Evaluating the effects of oligopin supplementation on the turnover of bone formation and antioxidant changes in postmenopausal osteopenic women: A randomized double-blind clinical trial with placebo-concurrent controls
Red color represents old content. It may be empty showing addition in the new version.
Green color represents new content. It may be empty showing deletion in the new version.
Inline
Side by side
Added new contents,
deleted old contents,contents that are not changed.
New table contents
New table contents
Old table contents
Old table contents
Unchanged contents
Unchanged contents
Added new contents, contents that are not changed.
Deleted old contents, contents that are not changed.
Old table contents
Old table contents
Unchanged contents
Unchanged contents
New table contents
New table contents
Unchanged contents
Unchanged contents
Protocol summary
We aimed to investigate the effects of oligopin on bone turnover markers and plasma and peripheral mononuclear cells oxidative stress in postmenopausal women with osteopenia in a double-blind randomized clinical trial. Forty four women with osteopenia were divided into two groups randomly (22, having oligopin, 150 mg, once daily, for 12 weeks). The 2nd group (22 women with osteopenia) receives the same amount of the placebo. At the first and the end of the study, blood sample are taken to measure in order to peripheral blood mononuclear cells isolation and plasma separation. The levels of bone alkaline phosphatase and carboxy terminal collagen type I in plasma oxidative stress markers such as total anti-oxidant capacity, malondialdehyde, and protein carbonyl were evaluated. Furthermore, oxidative stress will be evaluated in peripheral blood mononuclear cells by measurement of expression and activity of magnesium superoxide dismutase,catalase and Nuclear factor (erythroid-derived 2)-like 2.
empty
We aimed to investigate the effects of oligopin on bone turnover markers and plasma and peripheral mononuclear cells oxidative stress in postmenopausal women with osteopenia in a double-blind randomized clinical trial. Forty four women with osteopenia were divided into two groups randomly (22, having oligopin, 150 mg, once daily, for 12 weeks). The 2nd group (22 women with osteopenia) receives the same amount of the placebo. At the first and the end of the study, blood sample are taken to measure in order to peripheral blood mononuclear cells isolation and plasma separation. The levels of bone alkaline phosphatase and carboxy terminal collagen type I in plasma oxidative stress markers such as total anti-oxidant capacity, malondialdehyde, and protein carbonyl were evaluated. Furthermore, oxidative stress will be evaluated in peripheral blood mononuclear cells by measurement of expression and activity of magnesium superoxide dismutase,catalase and Nuclear factor (erythroid-derived 2)-like 2.
هدف از مطالعه حاضر بررسي نقش احتمالی الیگوپین برماركرهاي بازآرايي استخوان ونيز استرس اکسیداتیو درپلاسما و سلول هاي تك هسته اي خون محيطي در زنان یائسه مبتلا به استئوپنی مي باشد. مطالعه حاضر به صورت يك کارآزمایی بالینی تصادفی شده دو سو کور در زنان یائسه مبتلا به استئوپنی انجام خواهد شد. این مطالعه بر روی 44 بیمار زن یائسه مبتلا به استئوپنی انجام خواهد شد. بیماران را به صورت تصادفی در دو گروه دریافت کننده مکمل (150 میلی گرم در روز) و دارونما قرار داده و به مدت 12 هفته مکمل یاری مي شوند. در ابتداو دوازده هفته پس از دريافت دارو و دارونما ،اندازه گیری نمایه های ساخت استخوانی شامل آلکالین فسفاتاز استخوانی و اندازه گیری تلوپپتید کربوکسی ترمینال کلاژن تيپ يك بعنوان نمایه تحلیل استخوان برای ارزیابی روند واگردش استخوان استفاده می شود. همچنین بررسی نقش احتمالی الیگوپین بر استرس اکسیداتیو از طریق سنجش استرس اكسيداتيو نظير ظرفيت تام آنتي اكسيداني، بيان ژن و فعاليت منگنز سوپراكسيد ديسموتاز ،كاتالاز و فاكنور شبه هسته اي مشتق از اريتروئيد مورد بررسی قرار خواهد گرفت.
empty
هدف از مطالعه حاضر بررسي نقش احتمالی الیگوپین برماركرهاي بازآرايي استخوان ونيز استرس اکسیداتیو درپلاسما و سلول هاي تك هسته اي خون محيطي در زنان یائسه مبتلا به استئوپنی مي باشد. مطالعه حاضر به صورت يك کارآزمایی بالینی تصادفی شده دو سو کور در زنان یائسه مبتلا به استئوپنی انجام خواهد شد. این مطالعه بر روی 44 بیمار زن یائسه مبتلا به استئوپنی انجام خواهد شد. بیماران را به صورت تصادفی در دو گروه دریافت کننده مکمل (150 میلی گرم در روز) و دارونما قرار داده و به مدت 12 هفته مکمل یاری مي شوند. در ابتداو دوازده هفته پس از دريافت دارو و دارونما ،اندازه گیری نمایه های ساخت استخوانی شامل آلکالین فسفاتاز استخوانی و اندازه گیری تلوپپتید کربوکسی ترمینال کلاژن تيپ يك بعنوان نمایه تحلیل استخوان برای ارزیابی روند واگردش استخوان استفاده می شود. همچنین بررسی نقش احتمالی الیگوپین بر استرس اکسیداتیو از طریق سنجش استرس اكسيداتيو نظير ظرفيت تام آنتي اكسيداني، بيان ژن و فعاليت منگنز سوپراكسيد ديسموتاز ،كاتالاز و فاكنور شبه هسته اي مشتق از اريتروئيد مورد بررسی قرار خواهد گرفت.
empty
To investigate the effects of oligopin on bone turnover markers and plasma and peripheral mononuclear cells oxidative stress in postmenopausal women with osteopenia in a double-blind randomized clinical trial.
To investigate the effects of oligopin on bone turnover markers and plasma and peripheral mononuclear cells oxidative stress in postmenopausal women with osteopenia in a double-blind randomized clinical trial.
empty
بررسي اثر الیگوپین برماركرهاي بازآرايي استخوان ونيز استرس اکسیداتیو در زنان یائسه مبتلا به استئوپنی
بررسي اثر الیگوپین برماركرهاي بازآرايي استخوان ونيز استرس اکسیداتیو در زنان یائسه مبتلا به استئوپنی
empty
A Randomized, Double-blind, Placebo-Controlled Trial
A Randomized, Double-blind, Placebo-Controlled Trial
empty
كارآزمايي باليني تصادفي دو سويه كور
كارآزمايي باليني تصادفي دو سويه كور
empty
Placebo and Oligopin® capsules were distributed by the site research officer who is unaware of the contents of the packages. Patients, health care clinicians and research staff involved in data collection and statistical analysis were blinded and unaware of the randomization and intervention of the patients.
Placebo and Oligopin® capsules were distributed by the site research officer who is unaware of the contents of the packages. Patients, health care clinicians and research staff involved in data collection and statistical analysis were blinded and unaware of the randomization and intervention of the patients.
empty
رندوم سازی بر اساس گروه بندی بر اساس سن( به سه گروه ۵۰-۵۵، ۵۵-۶۰ و ۶۰-۶۵ سال ) و BMI ( افراد با BMI بالاتر از ۲۷.۵ و کمتر از ۲۷.۵ kg/m2 )انجام شد.
فردی که در مطالعه شرکت نکرده بود، ظرفهای داروی دارای قفل کودک هر دو گروه را با قرار دادن قرصهای الیگوپین و دارونما داخل ظرف های یکسان و اختصاص کدهایی مطابق با هر بیمار آماده کرد. هم محققین و هم افراد شرکت کننده و هم افرادی که در آنالیز آماری شرکت داشتند در مطالعه از زمان تصادفی سازی تا زمان آنالیز دادهها کور بودند.
رندوم سازی بر اساس گروه بندی بر اساس سن( به سه گروه ۵۰-۵۵، ۵۵-۶۰ و ۶۰-۶۵ سال ) و BMI ( افراد با BMI بالاتر از ۲۷.۵ و کمتر از ۲۷.۵ kg/m2 )انجام شد. فردی که در مطالعه شرکت نکرده بود، ظرفهای داروی دارای قفل کودک هر دو گروه را با قرار دادن قرصهای الیگوپین و دارونما داخل ظرف های یکسان و اختصاص کدهایی مطابق با هر بیمار آماده کرد. هم محققین و هم افراد شرکت کننده و هم افرادی که در آنالیز آماری شرکت داشتند در مطالعه از زمان تصادفی سازی تا زمان آنالیز دادهها کور بودند.
empty
The inclusion criteria were postmenopausal women with a diagnosis of osteopenia ( -2.5 SD ≤ T-score ≤ -1 SD), age between 50-65, and having equal physical activities, complementary and pediatric therapies for at least three months before study entry.
The subjects were excluded if they had body mass index ≥ 40 kg/m2, the occurrence of any visible side effects of the intervention, fracture report during the follow-up period, refusal to continue the trial, history of acute and chronic disorders, and current smoking and alcohol intake. women receiving drugs affecting on bone metabolism were not permitted to participate in this study.
The inclusion criteria were postmenopausal women with a diagnosis of osteopenia ( -2.5 SD ≤ T-score ≤ -1 SD), age between 50-65, and having equal physical activities, complementary and pediatric therapies for at least three months before study entry. The subjects were excluded if they had body mass index ≥ 40 kg/m2, the occurrence of any visible side effects of the intervention, fracture report during the follow-up period, refusal to continue the trial, history of acute and chronic disorders, and current smoking and alcohol intake. women receiving drugs affecting on bone metabolism were not permitted to participate in this study.
empty
معیار ورود:
زنان یائسه
داشتن سن بالای 50 سال و کمتر از 65 سال
تشخیص استئوپنی که با -2.5 SD ≤ Tscore ≤ -1 SD تعریف میشود
داشتن فعالیت فیزیکی، تعذیه ای و مکمل درمانی یکسان طی حداقل سه ماه گذشته تا پایان مطالعه
معیار خروج:
سابقه بیماریهای مزمن
سابقه مصرف داروهايي که روي متابوليسم استخوان تأثير میگذارند و در دوسال گذشته بصورت منظم حداقل برای 6 ماه مصرف شده باشند
عدم تمایل به پذیرش تصادفی سازی (randomization)
وجود چاقی بیمارگونه (Morbid Obesity): وجود BMI بالای 40
معیار ورود: زنان یائسه داشتن سن بالای 50 سال و کمتر از 65 سال تشخیص استئوپنی که با -2.5 SD ≤ Tscore ≤ -1 SD تعریف میشود داشتن فعالیت فیزیکی، تعذیه ای و مکمل درمانی یکسان طی حداقل سه ماه گذشته تا پایان مطالعه معیار خروج: سابقه بیماریهای مزمن سابقه مصرف داروهايي که روي متابوليسم استخوان تأثير میگذارند و در دوسال گذشته بصورت منظم حداقل برای 6 ماه مصرف شده باشند عدم تمایل به پذیرش تصادفی سازی (randomization) وجود چاقی بیمارگونه (Morbid Obesity): وجود BMI بالای 40
empty
Oligopin ,150 mg , once daily, 12 week
placebo, 150 mg, once daily,12 weeks
Oligopin ,150 mg , once daily, 12 week placebo, 150 mg, once daily,12 weeks
empty
پلاسبو، 150 ميلي گرم، يك بار در روز به مدت 12 هفته
اليگوپين 150 میلی گرم ، يك بار در روز ، به مدت 12 هفته
پلاسبو، 150 ميلي گرم، يك بار در روز به مدت 12 هفته اليگوپين 150 میلی گرم ، يك بار در روز ، به مدت 12 هفته
empty
The levels of osteocalcin and carboxy-terminal collagen type I in plasma oxidative stress markers such as total antioxidant capacity, malondialdehyde, and protein carbonyl, total thiol content are evaluated. Furthermore, oxidative stress will be evaluated in peripheral blood mononuclear cells by measurement of expression and activity of magnesium superoxide dismutase, catalase in PBMCs, and Plasma and Nuclear factor (erythroid-derived 2)-like 2 expressions in PBMCs.
The levels of osteocalcin and carboxy-terminal collagen type I in plasma oxidative stress markers such as total antioxidant capacity, malondialdehyde, and protein carbonyl, total thiol content are evaluated. Furthermore, oxidative stress will be evaluated in peripheral blood mononuclear cells by measurement of expression and activity of magnesium superoxide dismutase, catalase in PBMCs, and Plasma and Nuclear factor (erythroid-derived 2)-like 2 expressions in PBMCs.
empty
در ابتداو دوازده هفته پس از دريافت دارو و دارونما ،اندازه گیری نمایه های ساخت استخوانی شامل ستئوکلسین و اندازه گیری تلوپپتید کربوکسی ترمینال کلاژن تيپ يك بعنوان نمایه تحلیل استخوان برای ارزیابی روند واگردش استخوان استفاده می شود. همچنین بررسی نقش احتمالی الیگوپین بر استرس اکسیداتیو از طریق سنجش استرس اكسيداتيو نظير ظرفيت تام آنتي اكسيداني،مالون دی آلدیید، پروتئین کربونیل، محتوای سولفیدریل، بيان ژن و فعاليت منگنز سوپراكسيد ديسموتاز ،كاتالاز در پلاسما و PBMC و بیان فاكنور شبه هسته اي مشتق از اريتروئيد مورد بررسی قرار خواهد گرفت.
در ابتداو دوازده هفته پس از دريافت دارو و دارونما ،اندازه گیری نمایه های ساخت استخوانی شامل ستئوکلسین و اندازه گیری تلوپپتید کربوکسی ترمینال کلاژن تيپ يك بعنوان نمایه تحلیل استخوان برای ارزیابی روند واگردش استخوان استفاده می شود. همچنین بررسی نقش احتمالی الیگوپین بر استرس اکسیداتیو از طریق سنجش استرس اكسيداتيو نظير ظرفيت تام آنتي اكسيداني،مالون دی آلدیید، پروتئین کربونیل، محتوای سولفیدریل، بيان ژن و فعاليت منگنز سوپراكسيد ديسموتاز ،كاتالاز در پلاسما و PBMC و بیان فاكنور شبه هسته اي مشتق از اريتروئيد مورد بررسی قرار خواهد گرفت.
General information
empty
43
43
2017-08-15, 1396/05/24
2017-08-25, 1396/06/03
2017-08-1525 00:00:00
empty
2018-02-01, 1396/11/12
2018-02-01 00:00:00
empty
2018-12-01, 1397/09/10
2018-12-01 00:00:00
empty
2019-03-01, 1397/12/10
2019-03-01 00:00:00
empty
we made a mistake in writing the expected recruitment start date because it had been written before the registration date by mistake. Since the manuscript is ready for submission, other parts including actual recruitment start date and end date, blinding, and allocation was completed.
The recruitment center was also changed from Shariarti Hospital to Shahid AkbarAbadi Hospital because of the impairment of Dual-energy X-ray absorptiometry (DEXA).
Since the trial has been completed, other parts were updated.
we made a mistake in writing the expected recruitment start date because it had been written before the registration date by mistake. Since the manuscript is ready for submission, other parts including actual recruitment start date and end date, blinding, and allocation was completed. The recruitment center was also changed from Shariarti Hospital to Shahid AkbarAbadi Hospital because of the impairment of Dual-energy X-ray absorptiometry (DEXA). Since the trial has been completed, other parts were updated.
empty
در ورژن قبلی تاریخ expected recruitment start به اشتباه پیش از registration date وارد شده بود که اصلاح شد. با توجه که در حال سامیت مقاله هستیم تاریخ های actual نیز تکمیل شد. به علاوه بخش blinding و allocation تکمیل شد.
به علاوه در ورژن نخست محل نمونه گیری بیمارستان شریعتی مرکز تحقیقات غدد و متابولیسم بود که به علت خراب بودن دستگاه سنجش تراکم استخوان در زمان نمونه گیری محل نمونه گیری به بیمارستان شهید اکبرآبادی تغییر یافت.
سایر بخشها که در ورژن قبلی نیز تکمیل نشده بودند به علت تکمیل پروژه و سابمیت مقاله به روز رسانی شدند.
در ورژن قبلی تاریخ expected recruitment start به اشتباه پیش از registration date وارد شده بود که اصلاح شد. با توجه که در حال سامیت مقاله هستیم تاریخ های actual نیز تکمیل شد. به علاوه بخش blinding و allocation تکمیل شد. به علاوه در ورژن نخست محل نمونه گیری بیمارستان شریعتی مرکز تحقیقات غدد و متابولیسم بود که به علت خراب بودن دستگاه سنجش تراکم استخوان در زمان نمونه گیری محل نمونه گیری به بیمارستان شهید اکبرآبادی تغییر یافت. سایر بخشها که در ورژن قبلی نیز تکمیل نشده بودند به علت تکمیل پروژه و سابمیت مقاله به روز رسانی شدند.
Postmenopausal women;
Aged between 50-65;
Diagnosis of osteopenia based on Tscore ( -2.5 SD ≤ Tscore ≤ -1 SD)
To have equal physical, pediatric and complementary therapies for at least three months before entrance to study
Postmenopausal women; Aged between 50-65; Diagnosis of osteopenia based on Tscore ( -2.5 SD ≤ Tscore ≤ -1 SD) To have equal physical, pediatric and complementary therapies for at least three months before entrance to study
داشتن سن بالای 50 سال و کمتر از 65 سال
زنان یائسه
تشخیص استئوپنی که با -2.5 SD ≤ Tscore ≤ -1 SD تعریف می¬شود
داشتن فعالیت فیزیکی، تعذیه ای و مکمل درمانی یکسان طی حداقل سه ماه گذشته تا پایان مطالعه
داشتن سن بالای 50 سال و کمتر از 65 سال زنان یائسه تشخیص استئوپنی که با -2.5 SD ≤ Tscore ≤ -1 SD تعریف می¬شود داشتن فعالیت فیزیکی، تعذیه ای و مکمل درمانی یکسان طی حداقل سه ماه گذشته تا پایان مطالعه
The subjects were excluded if they had body mass index ≥ 40 kg/m2, the occurrence of any visible side effects of the intervention,fracture report during the follow-up period, refusal to continue the trial, history of bone disorders, history of any malignancy, diabetes, kidney failure, hepatic disease, skeletal disorders, systemic inflammatory diseases, rheumatologic disorders, degenerative joint diseases, hyperthyroidism, Cushing's syndrome, history of gastrointestinal disease or bleeding, motor disabilities, untreated psychiatric illnesses such as Alzheimer's disease, Parkinson's disease, psychosis, and current smoking and alcohol intake.As for the history of the use of drugs, women receiving osteoporosis drugs (e.g. estrogen receptor-selective agonists / antagonists, bisphosphonates, PTH, and alternative HRTs), anticonvulsants (i.e. phenobarbital, phenytoin, sodium valproate), nonsteroidal anti-inflammatory drugs (i.e. naproxen, aspirin, and ibuprofen), thiazides, diuretics, glucocorticoids were not permitted to participate in this study.
The subjects were excluded if they had body mass index ≥ 40 kg/m2, the occurrence of any visible side effects of the intervention,fracture report during the follow-up period, refusal to continue the trial, history of bone disorders, history of any malignancy, diabetes, kidney failure, hepatic disease, skeletal disorders, systemic inflammatory diseases, rheumatologic disorders, degenerative joint diseases, hyperthyroidism, Cushing's syndrome, history of gastrointestinal disease or bleeding, motor disabilities, untreated psychiatric illnesses such as Alzheimer's disease, Parkinson's disease, psychosis, and current smoking and alcohol intake.As for the history of the use of drugs, women receiving osteoporosis drugs (e.g. estrogen receptor-selective agonists / antagonists, bisphosphonates, PTH, and alternative HRTs), anticonvulsants (i.e. phenobarbital, phenytoin, sodium valproate), nonsteroidal anti-inflammatory drugs (i.e. naproxen, aspirin, and ibuprofen), thiazides, diuretics, glucocorticoids were not permitted to participate in this study.
empty
Randomization was performed for all participants based on age (50–55, 55–60, and 60– 65 years old) and BMI (BMI more than 27.50 kg/m2and less than 27.50 kg/m2) to minimize any bias.
Randomization was performed for all participants based on age (50–55, 55–60, and 60– 65 years old) and BMI (BMI more than 27.50 kg/m2and less than 27.50 kg/m2) to minimize any bias.
empty
رندوم سازی بر اساس گروه بندی بر اساس سن( به سه گروه ۵۰-۵۵، ۵۵-۶۰ و ۶۰-۶۵ سال ) و BMI ( افراد با BMI بالاتر از ۲۷.۵ و کمتر از ۲۷.۵ kg/m2 )انجام شد
رندوم سازی بر اساس گروه بندی بر اساس سن( به سه گروه ۵۰-۵۵، ۵۵-۶۰ و ۶۰-۶۵ سال ) و BMI ( افراد با BMI بالاتر از ۲۷.۵ و کمتر از ۲۷.۵ kg/m2 )انجام شد
empty
Placebo and Oligopin® capsules were distributed by the site research officer who is unaware of the contents of the packages. Patients, health care clinicians and research staff involved in data collection and statistical analysis were blinded and unaware of the randomization and intervention of the patients.
It should be noted that capsules containing pine bark extract and placebo were identical in appearance, size, and color.
Placebo and Oligopin® capsules were distributed by the site research officer who is unaware of the contents of the packages. Patients, health care clinicians and research staff involved in data collection and statistical analysis were blinded and unaware of the randomization and intervention of the patients. It should be noted that capsules containing pine bark extract and placebo were identical in appearance, size, and color.
empty
تصادفی سازی توسط متخصص آماری که در انجام مطالعه دخالت نداشت و با اختصاص یک شماره به هر بیمار به انجام رسید. کپسول¬های الیگوپین و دارونما یکسان بودند. فردی که در مطالعه شرکت نکرده بود، ظرفهای داروی دارای قفل کودک هر دو گروه را با قرار دادن قرص¬های الیگوپین و دارونما داخل ظرف¬های یکسان و اختصاص کدهایی مطابق با هر بیمار آماده کرد. هم محققین و هم افراد شرکت کننده و هم افرادی که در آنالیز آماری شرکت داشتند در مطالعه از زمان تصادفی سازی تا زمان آنالیز داده¬ها کور بودند.
تصادفی سازی توسط متخصص آماری که در انجام مطالعه دخالت نداشت و با اختصاص یک شماره به هر بیمار به انجام رسید. کپسول¬های الیگوپین و دارونما یکسان بودند. فردی که در مطالعه شرکت نکرده بود، ظرفهای داروی دارای قفل کودک هر دو گروه را با قرار دادن قرص¬های الیگوپین و دارونما داخل ظرف¬های یکسان و اختصاص کدهایی مطابق با هر بیمار آماده کرد. هم محققین و هم افراد شرکت کننده و هم افرادی که در آنالیز آماری شرکت داشتند در مطالعه از زمان تصادفی سازی تا زمان آنالیز داده¬ها کور بودند.
empty
empty
Primary outcomes
#1
Bone alkaline phospatase
Carboxy terminal collagen type I
Bone alkaline phospataseCarboxy terminal collagen type I
آلكالن فسفاتاز ، ايزوزيم استخواني
Ctx1
آلكالن فسفاتاز ، ايزوزيم استخوانيCtx1
#2
Carboxy terminal collagen type I
Osteocalcin
Carboxy terminal collagen type IOsteocalcin
Ctx1
استئوکلسین
Ctx1استئوکلسین
الايزا
الایزا
الايزاالایزا
#3
empty
Osteocalcin/CTX1 ratio
Osteocalcin/CTX1 ratio
empty
نسبت استئوکلسین به CTX1
نسبت استئوکلسین به CTX1
empty
Before and third month after interventio
Before and third month after interventio
empty
قبل از مداخله، سه ماه پس از مداخله
قبل از مداخله، سه ماه پس از مداخله
empty
--
--
empty
--
--
Secondary outcomes
#1
MnSOD activity in peripheral blood mononuclear cells (PBMCs) in postmenopausal osteopenic women and placebo-concurrent controls
MnSOD activity in plasma and peripheral blood mononuclear cells (PBMCs) in postmenopausal osteopenic women and placebo-concurrent controls
MnSOD activity in plasma and peripheral blood mononuclear cells (PBMCs) in postmenopausal osteopenic women and placebo-concurrent controls
فعالیت آنزیمی منگنز سوپراكسيد ديسموتاز در سلول هاي تك هسته اي خون محيطي در دو گروه دريافت كننده مكمل اليگوپين و پلاسبو
فعالیت آنزیمی منگنز سوپراكسيد ديسموتاز در پلاسما و سلول هاي تك هسته اي خون محيطي در دو گروه دريافت كننده مكمل اليگوپين و پلاسبو
فعالیت آنزیمی منگنز سوپراكسيد ديسموتاز در پلاسما و سلول هاي تك هسته اي خون محيطي در دو گروه دريافت كننده مكمل اليگوپين و پلاسبو
#2
Catalse activity in peripheral blood mononuclear cells (PBMCs) in postmenopausal osteopenic women and placebo-concurrent controls
Catalse activity in plasma and peripheral blood mononuclear cells (PBMCs) in postmenopausal osteopenic women and placebo-concurrent controls
Catalse activity in plasma and peripheral blood mononuclear cells (PBMCs) in postmenopausal osteopenic women and placebo-concurrent controls
فعالیت آنزیمی کاتالاز در سلول هاي تك هسته اي خون محيطي در دو گروه دريافت كننده مكمل اليگوپين و پلاسبو
فعالیت آنزیمی کاتالاز در پلاسما و سلول هاي تك هسته اي خون محيطي در دو گروه دريافت كننده مكمل اليگوپين و پلاسبو
فعالیت آنزیمی کاتالاز در پلاسما و سلول هاي تك هسته اي خون محيطي در دو گروه دريافت كننده مكمل اليگوپين و پلاسبو
#3
NrF2 protein levels in peripheral blood mononuclear cells (PBMCs) in postmenopausal osteopenic women and placebo-concurrent controls
NrF2 gene expression in peripheral blood mononuclear cells (PBMCs) in postmenopausal osteopenic women and placebo-concurrent controls
NrF2 protein levelsgene expression in peripheral blood mononuclear cells (PBMCs) in postmenopausal osteopenic women and placebo-concurrent controls
بیان پروتئین فاكتور شبه هسته اي مشتق از اريتروئيد 2 در سلول هاي تك هسته اي خون محيطي در دو گروه دريافت كننده مكمل اليگوپين و پلاسبو
بیان ژن فاكتور شبه هسته اي مشتق از اريتروئيد 2 در سلول هاي تك هسته اي خون محيطي در دو گروه دريافت كننده مكمل اليگوپين و پلاسبو
بیان پروتئینژن فاكتور شبه هسته اي مشتق از اريتروئيد 2 در سلول هاي تك هسته اي خون محيطي در دو گروه دريافت كننده مكمل اليگوپين و پلاسبو
ELISA
Real-Time PCR
ELISAReal-Time PCR
الايزا
ریل تایم PCR
الايزاریل تایم PCR
#4
NrF2 expression in peripheral blood mononuclear cells (PBMCs) in postmenopausal osteopenic women and placebo-concurrent controls
MDA plasma levels in postmenopausal osteopenic women and placebo-concurrent controls
NrF2 expression in peripheral blood mononuclear cells (PBMCs)MDA plasma levels in postmenopausal osteopenic women and placebo-concurrent controls
بيان ژن فاكتور شبه هسته اي مشتق از اريتروئيد 2 در سلول هاي تك هسته اي خون محيطي در دو گروه دريافت كننده مكمل اليگوپين و پلاسبو
ميزان پلاسمايي مالون دي آلدهيد در دو گروه دريافت كننده مكمل اليگوپين و پلاسبو
بيان ژن فاكتور شبه هسته اي مشتق از اريتروئيد 2 در سلول هاي تك هسته اي خون محيطيميزان پلاسمايي مالون دي آلدهيد در دو گروه دريافت كننده مكمل اليگوپين و پلاسبو
real-time PCR
spectrophotometer
real-time PCRspectrophotometer
Real-Time PCR
اسپكتروفوتومتري
Real-Time PCRاسپكتروفوتومتري
#5
MDA plasma levels in postmenopausal osteopenic women and placebo-concurrent controls
Plasma levels of total antioxidant capacity in postmenopausal osteopenic women and placebo-concurrent controls
MDA plasmaPlasma levels of total antioxidant capacity in postmenopausal osteopenic women and placebo-concurrent controls
ميزان پلاسمايي مالون دي آلدهيد در دو گروه دريافت كننده مكمل اليگوپين و پلاسبو
ظرفیت تام آنتی اکسیدانی پلاسما در دو گروه دريافت كننده مكمل اليگوپين و پلاسبو
ميزان پلاسمايي مالون دي آلدهيدظرفیت تام آنتی اکسیدانی پلاسما در دو گروه دريافت كننده مكمل اليگوپين و پلاسبو
#6
Plasma levels of total antioxidant capacity in postmenopausal osteopenic women and placebo-concurrent controls
Evaluating plasma levels of protein carbonylation in postmenopausal osteopenic women and placebo-concurrent controlsP
PlasmaEvaluating plasma levels of total antioxidant capacityprotein carbonylation in postmenopausal osteopenic women and placebo-concurrent controlscontrolsP
ظرفیت تام آنتی اکسیدانی پلاسما در دو گروه دريافت كننده مكمل اليگوپين و پلاسبو
ميزان پلاسمايي پروتئين كربونيل در دو گروه دريافت كننده مكمل اليگوپين و پلاسبو
ظرفیت تام آنتی اکسیدانی پلاسماميزان پلاسمايي پروتئين كربونيل در دو گروه دريافت كننده مكمل اليگوپين و پلاسبو
#7
Evaluating plasma levels of protein carbonylation in postmenopausal osteopenic women and placebo-concurrent controlsP
Evaluating plasma levels of total thiol contents in postmenopausal osteopenic women and placebo-concurrent controls
Evaluating plasma levels of protein carbonylationtotal thiol contents in postmenopausal osteopenic women and placebo-concurrent controlsPcontrols
ميزان پلاسمايي پروتئين كربونيل در دو گروه دريافت كننده مكمل اليگوپين و پلاسبو
ميزان پلاسمايي پروتئين سولفیدریل در دو گروه دريافت كننده مكمل اليگوپين و پلاسبو
ميزان پلاسمايي پروتئين كربونيلسولفیدریل در دو گروه دريافت كننده مكمل اليگوپين و پلاسبو
اسپكتروفوتومتري
اسپکتروفوتومتری
اسپكتروفوتومترياسپکتروفوتومتری
Recruitment centers
#1
Name of recruitment center - English: Shariati Hospital
Name of recruitment center - Persian: بيمارستان شريعتي
Full name of responsible person - English:
Full name of responsible person - Persian:
Street address - English:
Street address - Persian:
City - English: Tehran
City - Persian: تهران
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Shahid Akbarabadi hospital.
Name of recruitment center - Persian: بيمارستان شهید اکبرآبادی
Full name of responsible person - English: Afsaneh Ghasemi-Solaleh Emamgholipour
Full name of responsible person - Persian: افسانه قاسمی-سلاله امامقلی پور
Street address - English: Mowlavi St., Ferdows Gardens Statio
Street address - Persian: تهران، خیابان مولوی،نرسیده به چهارراه مولوی، ایستگاه باغ فردوس
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1168743514
Phone: +98 21 5560 6034
Fax:
Email: akbarabadihosp@yahoo.com
Web page address:
Name of recruitment center - English: Shariati HospitalShahid Akbarabadi hospital. Name of recruitment center - Persian: بيمارستان شريعتيشهید اکبرآبادی Full name of responsible person - English: Afsaneh Ghasemi-Solaleh Emamgholipour Full name of responsible person - Persian: افسانه قاسمی-سلاله امامقلی پور Street address - English: Mowlavi St., Ferdows Gardens Statio Street address - Persian: تهران، خیابان مولوی،نرسیده به چهارراه مولوی، ایستگاه باغ فردوس City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1168743514 Phone: +98 21 5560 6034 Fax: Email: akbarabadihosp@yahoo.com Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Vice Chancellor of Research,Tehran University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشكي تهران
Full name of responsible person - English: Dr. Masoud Younesian
Full name of responsible person - Persian: دكتر مسعود يونسيان
Street address - English: Faculty of Medicine, Tehran University of Medical Sciences, Poursina avenue Tehran Tehran Iran
Street address - Persian: دانشگاه علوم پزشكي تهران
City - English: Tehran
City - Persian: تهران
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Mohammad Ali Sahraian
Full name of responsible person - Persian: دكتر محمد علی صحراییان
Street address - English: Faculty of Medicine, Tehran University of Medical Sciences, Poursina avenue Tehran Tehran Iran
Street address - Persian: دانشگاه علوم پزشكي تهران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1416753955
Phone: +98 21 6443 2623
Fax:
Email: gsia@tums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Vice Chancellor of Research,Tehran University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشكي تهران Full name of responsible person - English: Dr. Masoud YounesianMohammad Ali Sahraian Full name of responsible person - Persian: دكتر مسعود يونسيانمحمد علی صحراییان Street address - English: Faculty of Medicine, Tehran University of Medical Sciences, Poursina avenue Tehran Tehran Iran Street address - Persian: دانشگاه علوم پزشكي تهران City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1416753955 Phone: +98 21 6443 2623 Fax: Email: gsia@tums.ac.ir Web page address:
empty
Public
public
empty
Domestic
domestic
empty
Academic
academic
Vice Chancellor of Research,Tehran University of Medical Sciences
Tehran University of Medical Sciences
Vice Chancellor of Research,TehranTehran University of Medical Sciences
دانشگاه علوم پزشكي تهران
دانشگاه علوم پزشکی تهران
دانشگاه علوم پزشكيپزشکی تهران
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Tehran University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشكي تهران
Full name of responsible person - English: Ziba Majidi
Full name of responsible person - Persian: زيبا مجيدي
Position - English: PhD student
Position - Persian: دانشجوي دكتراي تخصصي
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Department of Biochemistry, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran
Street address - Persian: دانشگاه علوم پزشكي تهران، دانشكده پزشكي،گروه بيوشيمي
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 00982164432623
Phone: +98 21 6443 2623
Mobile: 00
Fax:
Email: s.emamgholipour@gmail.com ; semamgholipour@sina.tums.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Tehran University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشكي تهران
Full name of responsible person - English: Solaleh Emamgholipour
Full name of responsible person - Persian: سلاله امامقلی پور
Position - English: Assistant Professor
Position - Persian: استادیار
Latest degree: phd
Area of specialty/work: 25
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Department of Biochemistry, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran
Street address - Persian: دانشگاه علوم پزشكي تهران، دانشكده پزشكي،گروه بيوشيمي
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 00982164432623
Phone: +98 21 6443 2623
Mobile: +98 912 604 9894
Fax:
Email: semamgholipour@sina.tums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Tehran University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشكي تهران Full name of responsible person - English: Ziba MajidiSolaleh Emamgholipour Full name of responsible person - Persian: زيبا مجيديسلاله امامقلی پور Position - English: PhD studentAssistant Professor Position - Persian: دانشجوي دكتراي تخصصياستادیار Latest degree: phd Area of specialty/work: 025 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Department of Biochemistry, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran Street address - Persian: دانشگاه علوم پزشكي تهران، دانشكده پزشكي،گروه بيوشيمي City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 00982164432623 Phone: +98 21 6443 2623 Mobile: 00+98 912 604 9894 Fax: Email: s.emamgholipour@gmail.com ; semamgholipour@sina.tums.ac.ir Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Department of Biochemistry, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran
Name of organization / entity - Persian: دانشگاه علوم پزشكي تهران
Full name of responsible person - English: Solaleh Emamgholipour
Full name of responsible person - Persian: سلاله امامقلي پور
Position - English: PhD,Clinical Biochemistry,Assistant professor
Position - Persian: دكتراي تخصصي بيوشيمي باليني ،استاديار
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Department of Biochemistry, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran
Street address - Persian: دانشگاه علوم پزشكي تهران، دانشكده پزشكي،گروه بيوشيمي
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 21 6443 2623
Mobile: +98 912 604 9894
Fax:
Email: semamgholipour@sina.tums.ac.ir ; s.emamgholipour@gmail.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Department of Biochemistry, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran
Name of organization / entity - Persian: دانشگاه علوم پزشكي تهران
Full name of responsible person - English: Solaleh Emamgholipour
Full name of responsible person - Persian: سلاله امامقلي پور
Position - English: PhD,Clinical Biochemistry,Assistant professor
Position - Persian: دكتراي تخصصي بيوشيمي باليني ،استاديار
Latest degree: phd
Area of specialty/work: 25
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Department of Biochemistry, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran
Street address - Persian: دانشگاه علوم پزشكي تهران، دانشكده پزشكي،گروه بيوشيمي
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1416634793
Phone: +98 21 6443 2623
Mobile: +98 912 604 9894
Fax:
Email: semamgholipour@sina.tums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Department of Biochemistry, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran Name of organization / entity - Persian: دانشگاه علوم پزشكي تهران Full name of responsible person - English: Solaleh Emamgholipour Full name of responsible person - Persian: سلاله امامقلي پور Position - English: PhD,Clinical Biochemistry,Assistant professor Position - Persian: دكتراي تخصصي بيوشيمي باليني ،استاديار Latest degree: phd Area of specialty/work: 025 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Department of Biochemistry, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran Street address - Persian: دانشگاه علوم پزشكي تهران، دانشكده پزشكي،گروه بيوشيمي City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1416634793 Phone: +98 21 6443 2623 Mobile: +98 912 604 9894 Fax: Email: semamgholipour@sina.tums.ac.ir ; s.emamgholipour@gmail.com Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Department of Biochemistry, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran
Name of organization / entity - Persian: دانشگاه علوم پزشكي تهران
Full name of responsible person - English: Solaleh Emamgholipour
Full name of responsible person - Persian: سلاله امامقلي پور
Position - English: PhD,Clinical Biochemistry,Assistant professor
Position - Persian: دكتراي تخصصي بيوشيمي باليني، استاديار
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Department of Biochemistry, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran
Street address - Persian: دانشگاه علوم پزشكي تهران، دانشكده پزشكي،گروه بيوشيمي
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 00982164432623
Mobile: +98 912 604 9894
Fax:
Email: semamgholipour@sina.tums.ac.ir; s.emamgholipour@gmail.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Department of Biochemistry, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran
Name of organization / entity - Persian: دانشگاه علوم پزشكي تهران
Full name of responsible person - English: Solaleh Emamgholipour
Full name of responsible person - Persian: سلاله امامقلي پور
Position - English: PhD,Clinical Biochemistry,Assistant professor
Position - Persian: دكتراي تخصصي بيوشيمي باليني، استاديار
Latest degree: phd
Area of specialty/work: 25
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Department of Biochemistry, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran
Street address - Persian: دانشگاه علوم پزشكي تهران، دانشكده پزشكي،گروه بيوشيمي
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1416634793
Phone: +98 982164432623
Mobile: +98 912 604 9894
Fax:
Email: semamgholipour@sina.tums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Department of Biochemistry, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran Name of organization / entity - Persian: دانشگاه علوم پزشكي تهران Full name of responsible person - English: Solaleh Emamgholipour Full name of responsible person - Persian: سلاله امامقلي پور Position - English: PhD,Clinical Biochemistry,Assistant professor Position - Persian: دكتراي تخصصي بيوشيمي باليني، استاديار Latest degree: phd Area of specialty/work: 025 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Department of Biochemistry, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran Street address - Persian: دانشگاه علوم پزشكي تهران، دانشكده پزشكي،گروه بيوشيمي City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1416634793 Phone: +98 00982164432623982164432623 Mobile: +98 912 604 9894 Fax: Email: semamgholipour@sina.tums.ac.ir; s.emamgholipour@gmail.com Web page address:
Sharing plan
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
undecided
undecided
undecided
undecided
empty
Data are available on request to the authors after manuscript publication.
Data are available on request to the authors after manuscript publication.
empty
داده ها پس از چاپ مقاله در صورت درخواست از نویسنده مسئول به اشتراک گذاشته می شود.
داده ها پس از چاپ مقاله در صورت درخواست از نویسنده مسئول به اشتراک گذاشته می شود.
empty
when summary data are published
when summary data are published
empty
پس از چاپ مقاله مستخرج از کارآزمایی بالینی
پس از چاپ مقاله مستخرج از کارآزمایی بالینی
empty
This is only available for people working
This is only available for people working
empty
برای محققین شاغل در موسسات دانشگاهی
برای محققین شاغل در موسسات دانشگاهی
empty
----
----
empty
----
----
empty
Corresponding authors' email addresses
Corresponding authors' email addresses
empty
ایمیل نویسنده مسئول مقاله
ایمیل نویسنده مسئول مقاله
empty
---
---
empty
-----
-----
Protocol summary
Study aim
To investigate the effects of oligopin on bone turnover markers and plasma and peripheral mononuclear cells oxidative stress in postmenopausal women with osteopenia in a double-blind randomized clinical trial.
Design
A Randomized, Double-blind, Placebo-Controlled Trial
Settings and conduct
Placebo and Oligopin® capsules were distributed by the site research officer who is unaware of the contents of the packages. Patients, health care clinicians and research staff involved in data collection and statistical analysis were blinded and unaware of the randomization and intervention of the patients.
Participants/Inclusion and exclusion criteria
The inclusion criteria were postmenopausal women with a diagnosis of osteopenia ( -2.5 SD ≤ T-score ≤ -1 SD), age between 50-65, and having equal physical activities, complementary and pediatric therapies for at least three months before study entry.
The subjects were excluded if they had body mass index ≥ 40 kg/m2, the occurrence of any visible side effects of the intervention, fracture report during the follow-up period, refusal to continue the trial, history of acute and chronic disorders, and current smoking and alcohol intake. women receiving drugs affecting on bone metabolism were not permitted to participate in this study.
Intervention groups
Oligopin ,150 mg , once daily, 12 week
placebo, 150 mg, once daily,12 weeks
Main outcome variables
The levels of osteocalcin and carboxy-terminal collagen type I in plasma oxidative stress markers such as total antioxidant capacity, malondialdehyde, and protein carbonyl, total thiol content are evaluated. Furthermore, oxidative stress will be evaluated in peripheral blood mononuclear cells by measurement of expression and activity of magnesium superoxide dismutase, catalase in PBMCs, and Plasma and Nuclear factor (erythroid-derived 2)-like 2 expressions in PBMCs.
General information
Reason for update
we made a mistake in writing the expected recruitment start date because it had been written before the registration date by mistake. Since the manuscript is ready for submission, other parts including actual recruitment start date and end date, blinding, and allocation was completed.
The recruitment center was also changed from Shariarti Hospital to Shahid AkbarAbadi Hospital because of the impairment of Dual-energy X-ray absorptiometry (DEXA).
Since the trial has been completed, other parts were updated.
Acronym
IRCT registration information
IRCT registration number:IRCT2017060334308N1
Registration date:2017-08-20, 1396/05/29
Registration timing:prospective
Last update:2020-05-16, 1399/02/27
Update count:1
Registration date
2017-08-20, 1396/05/29
Registrant information
Name
Solaleh Emamgholipour
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6443 2623
Email address
semamgholipour@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2017-08-25, 1396/06/03
Expected recruitment end date
2018-08-15, 1397/05/24
Actual recruitment start date
2018-02-01, 1396/11/12
Actual recruitment end date
2018-12-01, 1397/09/10
Trial completion date
2019-03-01, 1397/12/10
Scientific title
Evaluating the effects of oligopin supplementation on the turnover of bone formation and antioxidant changes in postmenopausal osteopenic women: A randomized double-blind clinical trial with placebo-concurrent controls
Public title
Evaluating the effects of oligopin supplementation on the turnover of bone formation and antioxidant changes in postmenopausal osteopenic women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Postmenopausal women;
Aged between 50-65;
Diagnosis of osteopenia based on Tscore ( -2.5 SD ≤ Tscore ≤ -1 SD)
To have equal physical, pediatric and complementary therapies for at least three months before entrance to study
Exclusion criteria:
The subjects were excluded if they had body mass index ≥ 40 kg/m2, the occurrence of any visible side effects of the intervention,fracture report during the follow-up period, refusal to continue the trial, history of bone disorders, history of any malignancy, diabetes, kidney failure, hepatic disease, skeletal disorders, systemic inflammatory diseases, rheumatologic disorders, degenerative joint diseases, hyperthyroidism, Cushing's syndrome, history of gastrointestinal disease or bleeding, motor disabilities, untreated psychiatric illnesses such as Alzheimer's disease, Parkinson's disease, psychosis, and current smoking and alcohol intake.As for the history of the use of drugs, women receiving osteoporosis drugs (e.g. estrogen receptor-selective agonists / antagonists, bisphosphonates, PTH, and alternative HRTs), anticonvulsants (i.e. phenobarbital, phenytoin, sodium valproate), nonsteroidal anti-inflammatory drugs (i.e. naproxen, aspirin, and ibuprofen), thiazides, diuretics, glucocorticoids were not permitted to participate in this study.
Age
From 50 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
44
Actual sample size reached:
43
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was performed for all participants based on age (50–55, 55–60, and 60– 65 years old) and BMI (BMI more than 27.50 kg/m2and less than 27.50 kg/m2) to minimize any bias.
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo and Oligopin® capsules were distributed by the site research officer who is unaware of the contents of the packages. Patients, health care clinicians and research staff involved in data collection and statistical analysis were blinded and unaware of the randomization and intervention of the patients.
It should be noted that capsules containing pine bark extract and placebo were identical in appearance, size, and color.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences (TUMS)
Street address
Tehran University of Medical Sciences (TUMS)
City
Tehran
Province
Tehran
Postal code
1416634793
Approval date
2017-05-23, 1396/03/02
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1396.2372
Health conditions studied
1
Description of health condition studied
Osteopenia
ICD-10 code
M 81.0
ICD-10 code description
Postmenopausal osteoporosis
Primary outcomes
1
Description
Carboxy terminal collagen type I
Timepoint
Before and third month after intervention
Method of measurement
ELISA
2
Description
Osteocalcin
Timepoint
Before and third month after intervention
Method of measurement
ELISA
3
Description
Osteocalcin/CTX1 ratio
Timepoint
Before and third month after interventio
Method of measurement
--
Secondary outcomes
1
Description
MnSOD activity in plasma and peripheral blood mononuclear cells (PBMCs) in postmenopausal osteopenic women and placebo-concurrent controls
Timepoint
At first of study,third month
Method of measurement
spectrophotometer
2
Description
Catalse activity in plasma and peripheral blood mononuclear cells (PBMCs) in postmenopausal osteopenic women and placebo-concurrent controls
Timepoint
Before intervention,third month after intervention
Method of measurement
spectrophotometer
3
Description
NrF2 gene expression in peripheral blood mononuclear cells (PBMCs) in postmenopausal osteopenic women and placebo-concurrent controls
Timepoint
Before intervention,third month after intervention
Method of measurement
Real-Time PCR
4
Description
MnSOD expression in peripheral blood mononuclear cells (PBMCs) in postmenopausal osteopenic women and placebo-concurrent controls
Timepoint
Before intervention,third month after intervention
Method of measurement
real-time PCR
5
Description
Catalase expression in peripheral blood mononuclear cells (PBMCs) in postmenopausal osteopenic women and placebo-concurrent controls
Timepoint
Before intervention,third month after intervention
Method of measurement
real-time PCR
6
Description
MDA plasma levels in postmenopausal osteopenic women and placebo-concurrent controls
Timepoint
Before intervention,third month after intervention
Method of measurement
spectrophotometer
7
Description
Plasma levels of total antioxidant capacity in postmenopausal osteopenic women and placebo-concurrent controls
Timepoint
Before intervention,third month after intervention
Method of measurement
spectrophotometer
8
Description
Evaluating plasma levels of protein carbonylation in postmenopausal osteopenic women and placebo-concurrent controlsP
Timepoint
Before intervention,third month after intervention
Method of measurement
spectrophotometer
9
Description
Evaluating plasma levels of total thiol contents in postmenopausal osteopenic women and placebo-concurrent controls
Timepoint
Before intervention,third month after intervention
Method of measurement
spectrophotometer
Intervention groups
1
Description
placebo, 150 mg,once daily,12 weeks
Category
Treatment - Drugs
2
Description
Oligopin ,150 mg ,once daily, 12 week
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Akbarabadi hospital.
Full name of responsible person
Afsaneh Ghasemi-Solaleh Emamgholipour
Street address
Mowlavi St., Ferdows Gardens Statio
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 5560 6034
Email
akbarabadihosp@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahraian
Street address
Faculty of Medicine, Tehran University of Medical Sciences, Poursina avenue Tehran Tehran Iran
City
Tehran
Province
Tehran
Postal code
1416753955
Phone
+98 21 6443 2623
Email
gsia@tums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Solaleh Emamgholipour
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Department of Biochemistry, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
00982164432623
Phone
+98 21 6443 2623
Fax
Email
semamgholipour@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Biochemistry, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran
Full name of responsible person
Solaleh Emamgholipour
Position
PhD,Clinical Biochemistry,Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Department of Biochemistry, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1416634793
Phone
+98 21 6443 2623
Fax
Email
semamgholipour@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Biochemistry, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran
Full name of responsible person
Solaleh Emamgholipour
Position
PhD,Clinical Biochemistry,Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Department of Biochemistry, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1416634793
Phone
+98 982164432623
Fax
Email
semamgholipour@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Data are available on request to the authors after manuscript publication.
When the data will become available and for how long
when summary data are published
To whom data/document is available
This is only available for people working
Under which criteria data/document could be used
----
From where data/document is obtainable
Corresponding authors' email addresses
What processes are involved for a request to access data/document