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Protocol summary
The aim of this double-blind randomized clinical trial is to determine the effects of isoflavones on cardiovascular disease risk factors, bone metabolism markers, serum concentrations of fructoseamine and advanced glycated end products in peritoneal dialysis patients.
The aim of this double-blind randomized clinical trial is to determine the effects of isoflavones on cardiovascular disease risk factors and bone metabolism markers in peritoneal dialysis patients.
The aim of this double-blind randomized clinical trial is to determine the effects of isoflavones on cardiovascular disease risk factors, and bone metabolism markers, serum concentrations of fructoseamine and advanced glycated end products in peritoneal dialysis patients.
هدف اين مطالعه كارآزمايي باليني تصادفي دو سو كور تعيين اثرات ایزوفلاون ها بر عوامل خطر بيماري هاي قلبي و عروقي، نشانگرهای متابوليسم استخوان و نیز غلظت سرمي گلوکز، فروکتوز آمين و محصولات نهايي گليکوزيلاسيون پیشرفته در بيماران تحت دياليز صفاقي است.
هدف اين مطالعه كارآزمايي باليني تصادفي دو سو كور تعيين اثرات ایزوفلاون ها بر عوامل خطر بيماري هاي قلبي و عروقي و نشانگرهای متابوليسم استخوان در بيماران تحت دياليز صفاقي است.
هدف اين مطالعه كارآزمايي باليني تصادفي دو سو كور تعيين اثرات ایزوفلاون ها بر عوامل خطر بيماري هاي قلبي و عروقي، و نشانگرهای متابوليسم استخوان و نیز غلظت سرمي گلوکز، فروکتوز آمين و محصولات نهايي گليکوزيلاسيون پیشرفته در بيماران تحت دياليز صفاقي است.
Serum concentrations of lipoprotein-a; malondialdehyde; high sensitivity c-reactive protein; Soluble intercellular adhesion molecule-1; bone alkaline phosphatase; osteocalcin; N-telopeptide; osteoprotegerin; Receptor activator of nuclear factor kappa-Β ligand; Intact parathyroid hormone; triglyceride; total cholesterol; High-density lipoprotein cholesterol; low-density lipoprotein cholesterol; fructoseamine; carboxymethyl lysine; pentosidine; glucose; albumin; calcium; phosphorous; blood pressure.
Serum concentrations of lipoprotein-a; malondialdehyde; high sensitivity c-reactive protein; Soluble intercellular adhesion molecule-1; Soluble vascular adhesion molecule-1; E-selectin; bone alkaline phosphatase; osteocalcin; N-telopeptide; osteoprotegerin; Receptor activator of nuclear factor kappa-Β ligand; Intact parathyroid hormone; triglyceride; total cholesterol; High-density lipoprotein cholesterol; low-density lipoprotein cholesterol; albumin; calcium; phosphorous; blood nitrogen urea; creatinine
غلظت سرمی لیپوپروتئین-a؛ مالون دی آلدهید؛ پروتئین واکنشگر C با حساسیت بالا؛ مولکول محلول چسبان بین سلولی - ۱؛ آلکالين فسفاتاز استخواني؛ استئوکلسین؛ N- تلوپپتید؛ استئوپروتگرین؛ گیرنده فاکتور هسته ای کاپا؛ پاراتورمون دست نخورده؛ تري گليسريد؛ كلسترول تام؛ کلسترول با چگالی بالا؛ کلسترول با چگالی پایین؛ فروکتوزآمين؛ کربوکسي متيل ليزين؛ پنتوزيدين؛ گلوکز سرم؛ آلبومين سرم؛ کلسيم؛ فسفر؛ فشار خون
غلظت سرمی لیپوپروتئین-a؛ مالون دی آلدهید؛ پروتئین واکنشگر C با حساسیت بالا؛ مولکول محلول چسبان بین سلولی - ۱؛ مولکول محلول چسبان عروقی - ۱؛ ای-سلکتین؛ آلکالين فسفاتاز استخواني؛ استئوکلسین؛ N- تلوپپتید؛ استئوپروتگرین؛ گیرنده فاکتور هسته ای کاپا؛ پاراتورمون دست نخورده؛ تري گليسريد؛ كلسترول تام؛ کلسترول با چگالی بالا؛ کلسترول با چگالی پایین؛ آلبومين سرم؛ کلسيم؛ فسفر؛ نیتروژن اوره خون؛ کراتینین
غلظت سرمی لیپوپروتئین-a؛ مالون دی آلدهید؛ پروتئین واکنشگر C با حساسیت بالا؛ مولکول محلول چسبان بین سلولی - ۱؛ مولکول محلول چسبان عروقی - ۱؛ ای-سلکتین؛ آلکالين فسفاتاز استخواني؛ استئوکلسین؛ N- تلوپپتید؛ استئوپروتگرین؛ گیرنده فاکتور هسته ای کاپا؛ پاراتورمون دست نخورده؛ تري گليسريد؛ كلسترول تام؛ کلسترول با چگالی بالا؛ کلسترول با چگالی پایین؛ فروکتوزآمين؛ کربوکسي متيل ليزين؛ پنتوزيدين؛ گلوکز سرم؛ آلبومين سرم؛ کلسيم؛ فسفر؛ فشارنیتروژن اوره خون؛ کراتینین
General information
empty
changes in some outcome variables
changes in some outcome variables
empty
تغییر چند متغیر پیامد مورد مطالعه
تغییر چند متغیر پیامد مورد مطالعه
Effects of isoflavones on cardiovascular disease risk factors, bone metabolism markers, serum concentrations of fructoseamine and advanced glycated end products in peritoneal dialysis patients
Effects of isoflavones on cardiovascular disease risk factors and bone metabolism markers in peritoneal dialysis patients
Effects of isoflavones on cardiovascular disease risk factors, and bone metabolism markers, serum concentrations of fructoseamine and advanced glycated end products in peritoneal dialysis patients
بررسی اثرات ایزوفلاون ها بر عوامل خطر بيماري هاي قلبي و عروقي، نشانگرهای متابوليسم استخوان و غلظت سرمي فروکتوز آمين و محصولات نهايي گليکوزيلاسيون پیشرفته در بيماران تحت دياليز صفاقي
بررسی اثرات ایزوفلاون ها بر عوامل خطر بيماري هاي قلبي و عروقي و نشانگرهای متابوليسم استخوان در بيماران تحت دياليز صفاقي
بررسی اثرات ایزوفلاون ها بر عوامل خطر بيماري هاي قلبي و عروقي، و نشانگرهای متابوليسم استخوان و غلظت سرمي فروکتوز آمين و محصولات نهايي گليکوزيلاسيون پیشرفته در بيماران تحت دياليز صفاقي
Primary outcomes
#1
empty
soluble vascular cellular adhesion molecule-1
soluble vascular cellular adhesion molecule-1
empty
مولکول محلول چسبان سلولهای عروق-1
مولکول محلول چسبان سلولهای عروق-1
empty
Before the intervention and 8 weeks after the intervention
Before the intervention and 8 weeks after the intervention
empty
قبل از شروع مداخله و 8 هفته پس از آن
قبل از شروع مداخله و 8 هفته پس از آن
empty
The enzyme-linked immunosorbent assay (ELISA)
The enzyme-linked immunosorbent assay (ELISA)
empty
کیت آزمایشگاهی آزمون ایمنوسوربنت متصل به آنزیم (الایزا)
کیت آزمایشگاهی آزمون ایمنوسوربنت متصل به آنزیم (الایزا)
#2
empty
E-selectin
E-selectin
empty
ای- سلکتین
ای- سلکتین
empty
Before the intervention and 8 weeks after the intervention
Before the intervention and 8 weeks after the intervention
empty
قبل از شروع مداخله و 8 هفته پس از آن
قبل از شروع مداخله و 8 هفته پس از آن
empty
The enzyme-linked immunosorbent assay (ELISA)
The enzyme-linked immunosorbent assay (ELISA)
empty
کیت آزمایشگاهی آزمون ایمنوسوربنت متصل به آنزیم (الایزا)
کیت آزمایشگاهی آزمون ایمنوسوربنت متصل به آنزیم (الایزا)
Secondary outcomes
#1
Serum concentrations of carboxymethyl lysine
Serum concentrations of albumin
Serum concentrations of carboxymethyl lysinealbumin
غلظت سرمی کربوکسی متیل لیزین
غلظت سرمی آلبومین
غلظت سرمی کربوکسی متیل لیزینآلبومین
The enzyme-linked immunosorbent assay (ELISA)
Enzymatic assay kit
The enzyme-linked immunosorbentEnzymatic assay (ELISA)kit
کیت آزمایشگاهی آزمون ایمنوسوربنت متصل به آنزیم (الایزا)
ارزیابی آنزیماتیک
کیت آزمایشگاهی آزمون ایمنوسوربنت متصل به آنزیم (الایزا)ارزیابی آنزیماتیک
#2
Serum concentrations of pentosidine
Serum concentrations of calcium
Serum concentrations of pentosidinecalcium
غلظت سرمی پنتوزیدین
غلظت سرمی کلسیم
غلظت سرمی پنتوزیدینکلسیم
The enzyme-linked immunosorbent assay (ELISA)
Colorimetric method using autoanalyzer
The enzyme-linked immunosorbent assay (ELISA)Colorimetric method using autoanalyzer
کیت آزمایشگاهی آزمون ایمنوسوربنت متصل به آنزیم (الایزا)
روش رنگ سنجي با استفاده از اتوآنالايزر
کیت آزمایشگاهی آزمون ایمنوسوربنت متصل به آنزیم (الایزا)روش رنگ سنجي با استفاده از اتوآنالايزر
#3
Serum concentrations of fructoseamine
Serum concentrations of phosphorous
Serum concentrations of fructoseaminephosphorous
غلظت سرمی فروکتوزآمین
غلظت سرمی فسفر
غلظت سرمی فروکتوزآمینفسفر
The enzyme-linked immunosorbent assay (ELISA)
Colorimetric method using autoanalyzer
The enzyme-linked immunosorbent assay (ELISA)Colorimetric method using autoanalyzer
کیت آزمایشگاهی آزمون ایمنوسوربنت متصل به آنزیم (الایزا)
روش رنگ سنجي با استفاده از اتوآنالايزر
کیت آزمایشگاهی آزمون ایمنوسوربنت متصل به آنزیم (الایزا)روش رنگ سنجي با استفاده از اتوآنالايزر
#4
Serum concentrations of glucose
blood nitrogen urea
Serum concentrations of glucoseblood nitrogen urea
غلظت سرمی گلوکز
نیتروژن اوره خون
غلظت سرمی گلوکزنیتروژن اوره خون
Enzymatic assay kit
Colorimetric method
Enzymatic assay kitColorimetric method
ارزیابی آنزیماتیک
رنگ سنجی
ارزیابی آنزیماتیکرنگ سنجی
#5
Serum concentrations of albumin
creatinine
Serum concentrations of albumincreatinine
غلظت سرمی آلبومین
کراتینین
غلظت سرمی آلبومینکراتینین
Enzymatic assay kit
Colorimetric method
Enzymatic assay kitColorimetric method
ارزیابی آنزیماتیک
روش رنگ سنجی
ارزیابی آنزیماتیکروش رنگ سنجی
#6
Serum concentrations of calcium
empty
Serum concentrations of calcium
غلظت سرمی کلسیم
empty
غلظت سرمی کلسیم
Before the intervention and 8 weeks after the intervention
empty
Before the intervention and 8 weeks after the intervention
قبل از شروع مداخله و 8 هفته پس از آن
empty
قبل از شروع مداخله و 8 هفته پس از آن
Colorimetric method using autoanalyzer
empty
Colorimetric method using autoanalyzer
روش رنگ سنجي با استفاده از اتوآنالايزر
empty
روش رنگ سنجي با استفاده از اتوآنالايزر
#7
Serum concentrations of phosphorous
empty
Serum concentrations of phosphorous
غلظت سرمی فسفر
empty
غلظت سرمی فسفر
Before the intervention and 8 weeks after the intervention
empty
Before the intervention and 8 weeks after the intervention
قبل از شروع مداخله و 8 هفته پس از آن
empty
قبل از شروع مداخله و 8 هفته پس از آن
Colorimetric method using autoanalyzer
empty
Colorimetric method using autoanalyzer
روش رنگ سنجي با استفاده از اتوآنالايزر
empty
روش رنگ سنجي با استفاده از اتوآنالايزر
#8
Systolic blood pressure
empty
Systolic blood pressure
فشارخون سیستولیک
empty
فشارخون سیستولیک
Before the intervention and 8 weeks after the intervention
empty
Before the intervention and 8 weeks after the intervention
قبل از شروع مداخله و 8 هفته پس از آن
empty
قبل از شروع مداخله و 8 هفته پس از آن
mercury sphygmomanometer
empty
mercury sphygmomanometer
فشارسنج جيوه اي
empty
فشارسنج جيوه اي
#9
Diastolic blood pressure
empty
Diastolic blood pressure
فشار خون دیاستولیک
empty
فشار خون دیاستولیک
Before the intervention and 8 weeks after the intervention
empty
Before the intervention and 8 weeks after the intervention
قبل از شروع مداخله و 8 هفته پس از آن
empty
قبل از شروع مداخله و 8 هفته پس از آن
mercury sphygmomanometer
empty
mercury sphygmomanometer
فشارسنج جيوه اي
empty
فشارسنج جيوه اي
Recruitment centers
#1
Name of recruitment center - English: shafa clinic
Name of recruitment center - Persian: کلینیک شفا
Full name of responsible person - English: shahnaz atabak
Full name of responsible person - Persian: دکتر شهناز اتابک
Street address - English: Valiasr square
Street address - Persian: میدان ولیعصر
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: -
Phone: +98 21 8889 6051
Fax:
Email: info@irankf.com
Web page address:
Name of recruitment center - English: Shafa Clinic
Name of recruitment center - Persian: کلینیک شفا
Full name of responsible person - English: Shahnaz Atabak
Full name of responsible person - Persian: دکتر شهناز اتابک
Street address - English: No 42, Hosseini Ave., Valiasr Square
Street address - Persian: میدان ولیعصر، خیابان حسینی، پلاک 42
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 6182965723
Phone: +98 21 8889 6051
Fax:
Email: Info@irankf.com
Web page address:
Name of recruitment center - English: shafa clinicShafa Clinic Name of recruitment center - Persian: کلینیک شفا Full name of responsible person - English: shahnaz atabakShahnaz Atabak Full name of responsible person - Persian: دکتر شهناز اتابک Street address - English: No 42, Hosseini Ave., Valiasr squareSquare Street address - Persian: میدان ولیعصر، خیابان حسینی، پلاک 42 City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: -6182965723 Phone: +98 21 8889 6051 Fax: Email: infoInfo@irankf.com Web page address:
#2
Name of recruitment center - English: Dr.najafi’s clinic
Name of recruitment center - Persian: کلینیک دکتر نجفی
Full name of responsible person - English: Iraj Najafi
Full name of responsible person - Persian: دکتر ایرج نجفی
Street address - English: Valiasr square
Street address - Persian: میدان ولیعصر
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: -
Phone: +98 21 8896 6916
Fax:
Email: info@irankf.com
Web page address:
Name of recruitment center - English: Dr.najafi’s Clinic
Name of recruitment center - Persian: کلینیک دکتر نجفی
Full name of responsible person - English: Iraj Najafi
Full name of responsible person - Persian: ایرج نجفی
Street address - English: No 8, Rooyan Ave., Valiasr Square
Street address - Persian: میدان ولیعصر، خیابان رویان، پلاک 8
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 6162365224
Phone: +98 21 8896 6916
Fax:
Email: Info@irankf.com
Web page address:
Name of recruitment center - English: Dr.najafi’s clinicClinic Name of recruitment center - Persian: کلینیک دکتر نجفی Full name of responsible person - English: Iraj Najafi Full name of responsible person - Persian: دکتر ایرج نجفی Street address - English: No 8, Rooyan Ave., Valiasr squareSquare Street address - Persian: میدان ولیعصر، خیابان رویان، پلاک 8 City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: -6162365224 Phone: +98 21 8896 6916 Fax: Email: infoInfo@irankf.com Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: National Nutrition and Food Technology Research Institute
Name of organization / entity - Persian: انستيتو تحقيقات تغذيه و صنايع غذايي كشور
Full name of responsible person - English: Dr. Esmat Naseri
Full name of responsible person - Persian: دكتر عصمت ناصري
Street address - English: No. 46, West Arghavan St., Farahzadi Blv., Shahrak Qods
Street address - Persian: شهرك قدس، بلوار فرحزادي، ارغوان غربي، پلاك 46
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1981619573
Phone: +98 21 2207 7425
Fax:
Email: info@nnftri.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: National Nutrition and Food Technology Research Institute
Name of organization / entity - Persian: انستيتو تحقيقات تغذيه و صنايع غذايي كشور
Full name of responsible person - English: Esmat Naseri
Full name of responsible person - Persian: عصمت ناصري
Street address - English: No. 46, West Arghavan St., Farahzadi Blv., Shahrak Qods
Street address - Persian: شهرك قدس، بلوار فرحزادي، ارغوان غربي، پلاك 46
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1981619573
Phone: +98 21 2207 7425
Fax:
Email: Nasseri_esm@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: National Nutrition and Food Technology Research Institute Name of organization / entity - Persian: انستيتو تحقيقات تغذيه و صنايع غذايي كشور Full name of responsible person - English: Dr. Esmat Naseri Full name of responsible person - Persian: دكتر عصمت ناصري Street address - English: No. 46, West Arghavan St., Farahzadi Blv., Shahrak Qods Street address - Persian: شهرك قدس، بلوار فرحزادي، ارغوان غربي، پلاك 46 City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1981619573 Phone: +98 21 2207 7425 Fax: Email: infoNasseri_esm@nnftri.ac.iryahoo.com Web page address:
Protocol summary
Study aim
The aim of this double-blind randomized clinical trial is to determine the effects of isoflavones on cardiovascular disease risk factors and bone metabolism markers in peritoneal dialysis patients.
Design
This study is a double-blind, randomized controlled clinical trial with two parallel groups. 50 patients will be randomly assigned into isoflavone and control group.
Settings and conduct
Patients under peritoneal dialysis referring to the Shafa clinic and Dr. Najafi clinic will be invited to participate. After assessing the entrance criteria, 7 cc blood samples are taken. The food recall is completed. Supplements are given to patients for a month. For double-blind implementation, in the beginning, all boxes of supplements by a third party is coded as A and B
Participants/Inclusion and exclusion criteria
Inclusion criteria: At least 6 months have passed since the onset of Continuous Ambulatory Peritoneal Dialysis; Being in the age range of 18-75 years
Exclusion criteria: Receiving isoflavones supplement
Intervention groups
Patients in the isoflavone group will receive, for 8 weeks, two tablets of Soyagol (Goldaru Company) per day, each containing 50 mg of soy isoflavone.
Patients in the control group will receive 2 tablets of placebo containing starch (Goldaru Company) per day.
Main outcome variables
Serum concentrations of lipoprotein-a; malondialdehyde; high sensitivity c-reactive protein; Soluble intercellular adhesion molecule-1; Soluble vascular adhesion molecule-1; E-selectin; bone alkaline phosphatase; osteocalcin; N-telopeptide; osteoprotegerin; Receptor activator of nuclear factor kappa-Β ligand; Intact parathyroid hormone; triglyceride; total cholesterol; High-density lipoprotein cholesterol; low-density lipoprotein cholesterol; albumin; calcium; phosphorous; blood nitrogen urea; creatinine
General information
Reason for update
changes in some outcome variables
Acronym
IRCT registration information
IRCT registration number:IRCT20181120041710N1
Registration date:2019-01-10, 1397/10/20
Registration timing:registered_while_recruiting
Last update:2019-11-28, 1398/09/07
Update count:1
Registration date
2019-01-10, 1397/10/20
Registrant information
Name
Zahra Yari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2235 7484
Email address
zahrayari_nut@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-28, 1397/09/07
Expected recruitment end date
2019-01-30, 1397/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of isoflavones on cardiovascular disease risk factors and bone metabolism markers in peritoneal dialysis patients
Public title
Effect of isoflavones supplementation in peritoneal dialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Continuous Ambulatory Peritoneal Dialysis for 6 months or more
Body mass index (BMI) below 35
Exclusion criteria:
Infectious diseases (especially peritonitis) and inflammatory diseases
Liver diseases
Past medical history of cancer
Receiving glucocorticoid drugs, non-steroidal anti-inflammatory drugs
Receiving isoflavone supplements
Constant consumption of soy or foods containing soy in the diet
Age
From 18 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Patients on the basis of diabetes are categorized and are randomly assigned to the soy isoflavone or placebo group. To random allocation, a Stratified Blocked Randomization method is used. After specifying blocks of size 4 and allocating numbers to each block, a random number table is used to determine the treatment assignment list. Randomization is concealed in sequentially numbered, sealed, opaque envelope.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double-blind (investigators and patients) trial. For double-blind implementation, at the beginning of the study, all boxes containing soybean isoflavone or placebo by a third party (someone other than the researchers) is coded as A and B.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of National Nutrition and Food Technology Research Institute
Street address
No. 46, West Arghavan St., Farahzadi Blv., Shahrak Qods,
City
Tehran
Province
Tehran
Postal code
1981619573
Approval date
2018-09-11, 1397/06/20
Ethics committee reference number
IR.SBMU.NNFTRI.REC.1397.001
Health conditions studied
1
Description of health condition studied
peritoneal dialysis patients
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Serum concentrations of lipoprotein(a) [Lp (a)]
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
Enzyme-linked immunosorbent assay (ELISA) kit
2
Description
Serum concentrations of malondialdehyde (MDA)
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
Enzyme-linked immunosorbent assay (ELISA) kit
3
Description
Serum concentrations of high sensitivity c-reactive protein (hs-CRP)
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
Enzyme-linked immunosorbent assay (ELISA) kit
4
Description
Serum concentrations of Soluble intercellular adhesion molecule-1 (sICAM-1)
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
Enzyme-linked immunosorbent assay (ELISA) kit
5
Description
Serum concentrations of bone alkaline phosphatase
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
The enzyme-linked immunosorbent assay (ELISA)
6
Description
Serum concentrations of Osteocalcin
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
The enzyme-linked immunosorbent assay (ELISA)
7
Description
Serum concentrations of N-telopeptide
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
The enzyme-linked immunosorbent assay (ELISA)
8
Description
Serum concentrations of Osteoprotegerin
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
The enzyme-linked immunosorbent assay (ELISA)
9
Description
Serum concentrations of Receptor activator of nuclear factor kappa-Β ligand (RANKL)
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
The enzyme-linked immunosorbent assay (ELISA)
10
Description
Serum concentrations of Intact parathyroid hormone (iPTH)
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
The enzyme-linked immunosorbent assay (ELISA)
11
Description
Serum concentrations of triglyceride
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
Enzymatic assay kit
12
Description
Serum concentrations of total cholesterol
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
Enzymatic assay kit
13
Description
Serum concentrations of High-density lipoprotein cholesterol (HDL-C)
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
Enzymatic assay kit
14
Description
Serum concentrations of low-density lipoprotein cholesterol (LDL-C)
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
Enzymatic assay kit
15
Description
soluble vascular cellular adhesion molecule-1
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
The enzyme-linked immunosorbent assay (ELISA)
16
Description
E-selectin
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
The enzyme-linked immunosorbent assay (ELISA)
Secondary outcomes
1
Description
Serum concentrations of albumin
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
Enzymatic assay kit
2
Description
Serum concentrations of calcium
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
Colorimetric method using autoanalyzer
3
Description
Serum concentrations of phosphorous
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
Colorimetric method using autoanalyzer
4
Description
blood nitrogen urea
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
Colorimetric method
5
Description
creatinine
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
Colorimetric method
Intervention groups
1
Description
Intervention group: isoflavone supplementation: they will receive, for 8 weeks, two tablets of Soyagol (Goldaru Company) per day, each containing 50 mg of soy isoflavone.
Category
Treatment - Other
2
Description
Control group: they will receive 2 tablets of placebo containing starch (Goldaru Company) per day for 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Clinic
Full name of responsible person
Shahnaz Atabak
Street address
No 42, Hosseini Ave., Valiasr Square
City
Tehran
Province
Tehran
Postal code
6182965723
Phone
+98 21 8889 6051
Email
Info@irankf.com
2
Recruitment center
Name of recruitment center
Dr.najafi’s Clinic
Full name of responsible person
Iraj Najafi
Street address
No 8, Rooyan Ave., Valiasr Square
City
Tehran
Province
Tehran
Postal code
6162365224
Phone
+98 21 8896 6916
Email
Info@irankf.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
National Nutrition and Food Technology Research Institute
Full name of responsible person
Esmat Naseri
Street address
No. 46, West Arghavan St., Farahzadi Blv., Shahrak Qods
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2207 7425
Email
Nasseri_esm@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National Nutrition and Food Technology Research Institute
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Yari
Position
Ph.D candidate
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
No. 46, West Arghavan St., Farahzadi Blv., Shahrak Qods
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2207 7424
Email
zahrayari_nut@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hadi Tabibi
Position
Associated Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No. 46, West Arghavan St., Farahzadi Blv., Shahrak Qods
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2207 7424
Email
hadtabibi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Yari
Position
Ph.D candidate
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
No. 46, West Arghavan St., Farahzadi Blv., Shahrak Qods
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2207 7424
Email
zahrayari_nut@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available