The Effect Of Concentrated Pomegranate Juice On Depression score , Insulin Resistance(HOMA-IR) , oxidative And Antioxidant Markers (TAC , MDA) In Women With Polycystic Ovary Syndrome(PCOS)
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Protocol summary
we will give concentrated pomegranate juice 50 cc daily to the intervention group and and we say to dilute it with 200 cc water daily and consume in the evening. The control group received no intervention.
we will give concentrated pomegranate juice 45 cc daily to the intervention group and and we say to dilute it with 180 cc water daily and consume in the evening. The control group received no intervention.
we will give concentrated pomegranate juice 5045 cc daily to the intervention group and and we say to dilute it with 200180 cc water daily and consume in the evening. The control group received no intervention.
50 سی سی کنسانتره آب انار را روزانه به گروه مداخله خواهیم داد و ذکر می کنیم که آن را با 200 سی سی آب رقیق کرده و در ساعت مشخصی در عصر مصرف کنند. گروه کنترل مداخله دریافت نمی کند.
45 سی سی کنسانتره آب انار را روزانه به گروه مداخله خواهیم داد و ذکر می کنیم که آن را با 180 سی سی آب رقیق کرده و در ساعت مشخصی در عصر مصرف کنند. گروه کنترل مداخله دریافت نمی کند.
5045 سی سی کنسانتره آب انار را روزانه به گروه مداخله خواهیم داد و ذکر می کنیم که آن را با 200180 سی سی آب رقیق کرده و در ساعت مشخصی در عصر مصرف کنند. گروه کنترل مداخله دریافت نمی کند.
General information
2020-01-21, 1398/11/01
2018-04-14, 1397/01/25
20202018-0104-2114 00:00:00
2020-05-21, 1399/03/01
2019-03-03, 1397/12/12
20202019-0503-2103 00:00:00
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Correction of sampling date
Correction of sampling date
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Intervention groups
#1
Intervention group: 45 ml Concentrated Pomegranate Juice for 8 weeks with 200 cc water, in the afternoon, Takeda factory of East Azarbaijan .
Intervention group: 45 ml Concentrated Pomegranate Juice for 8 weeks with 180 cc water, in the afternoon, Takeda factory of East Azarbaijan .
Intervention group: 45 ml Concentrated Pomegranate Juice for 8 weeks with 200180 cc water, in the afternoon, Takeda factory of East Azarbaijan .
گروه مداخله: 45 میلی لیتر کنسانتره آب انار به مدت 8 هفته همراه با 200 سی سی آب، در عصر، کارخانه تکدانه آذربایجان شرقی
گروه مداخله: 45 میلی لیتر کنسانتره آب انار به مدت 8 هفته همراه با 180سی سی آب، در عصر، کارخانه تکدانه آذربایجان شرقی
گروه مداخله: 45 میلی لیتر کنسانتره آب انار به مدت 8 هفته همراه با 200 سی180سی سی آب، در عصر، کارخانه تکدانه آذربایجان شرقی
Protocol summary
Study aim
The effect of concentrated pomegranate juice on depression score , insulin resistance , oxidative and antioxidant markers in women with polycystic ovary syndrome.
Design
clinical trial, Randomized, non-blind, having Control group
Settings and conduct
First, we select 44 patients with PCOS who referre to Shahid Beheshti Clinic in Isfahan and divide into two groups. Participants were asked to record their 3-day dietary intake (2 days per week and one day off) and to complete the DASS questionnaire and the intervention is implemented.Then, anthropometric measurements and blood pressure are performed and their fasting blood samples are taken and then the intervention is performed.
Individuals are asked not to alter their dietary intake, calorie intake, eating habits, and exercise routine during the study period. After 8 weeks, all of the above steps will be repeated.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 18≤age≤40, BMI ≥ 25, being single, not having acute and chronic diseases such as: cardiovascular disease, diabetes, hypothyroidism, hypertension, dyslipidemia, depression, not following a specific diet and exercise program, non-use of drugs such as oral contraceptive pill, hormonal drugs, anti-diabetic drugs, antioxidant supplements, not consuming pomegranates at least 2 months before the study. Exclusion criteria: pregnancy,not consuming concentrated pomegranate juice completely, not willing to continue participating in the study.
Intervention groups
we will give concentrated pomegranate juice 45 cc daily to the intervention group and and we say to dilute it with 180 cc water daily and consume in the evening. The control group received no intervention.
The Effect Of Concentrated Pomegranate Juice On Depression score , Insulin Resistance(HOMA-IR) , oxidative And Antioxidant Markers (TAC , MDA) In Women With Polycystic Ovary Syndrome(PCOS)
Public title
The effect of pomegranate juice concentrate in women with polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18≤Age≤40
BMI ≥ 25
Being single
Not having acute and chronic diseases such as: cardiovascular disease, kidney, liver, diabetes, hypothyroidism, hyperthyroidism, asthma, neoplastic, hyperprolactinemia, malabsorption disorders, hypertension, dyslipidemia, (new or during 6 months).
No Depression
Not following a specific diet.
Not following a specific exercise program.
Non-use of drugs such as contraceptive pills (Oral contraceptive pill), hormonal drugs, anti-diabetic drugs, anti-obesity drugs, antioxidant supplements and multivitamin minerals, blood lipid lowering drugs.
Not smoking
Not allergic to pomegranate and its products.
Not consuming pomegranates and pomegranate-containing products at least 2 months before starting the study
Exclusion criteria:
Pregnancy
Not consuming Concentrated Pomegranate Juice completely
Not willing to continue participating in the study
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
First, we select all individuals using available sampling method and after describing the aims and methods of the study, if they wish to participate in the study, we randomly divided them into two groups of Concentrated pomegranate juice and control.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
In this study, all individuals are divided into two groups: the first group receives the intervention and the second group is the control group that receives no intervention.
Secondary Ids
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Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Faculty of Nutrition, Isfahan University of Medical Sciences, Hezar Jarib Ave., Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2018-03-04, 1396/12/13
Ethics committee reference number
396806
Health conditions studied
1
Description of health condition studied
Polycystic Ovary Syndrome
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Evaluation of malondialdehyde in women with polycystic ovary syndrome
Timepoint
Baseline and 8 weeks after starting the study
Method of measurement
Measurement of serum malondialdehyde by calorimetric method using kiazist kit
Secondary outcomes
1
Description
Evaluation of total antioxidant capacity in women with polycystic ovary syndrome
Timepoint
Baseline and 8 weeks after starting the study
Method of measurement
Measurement of serum total antioxidant capacity by cupric reducing antioxidant capacity (CUPRAC) method using kiazist kit
2
Description
Evaluation of insulin resistance in women with polycystic ovary syndrome
Timepoint
Baseline and 8 weeks after starting the study
Method of measurement
Measurement of Insulin Resistance Using Formula (fasting plasma glucose (mMol/L) × insulin (µIU/mL))/22.5. The levels of serum insulin will be determined using ELISA kit (AccuBind, Monobind Inc., USA) and fasting blood sugar will be measured by enzymatic photometric method using standard kits (Pars Azmun, Tehran, Iran).