Protocol summary
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Study aim
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The aim of the present study is to investigate the effects of oral intake of thylakoid with low calorie diet on the metabolic, hormonal and inflammatory factors in obese women with polycystic ovary syndrome.
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Design
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Randomized double-blind clinical trial with two arm parallel groups
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Settings and conduct
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The study will be conducted in the Tabriz University of Medical Sciences associated clinics, and supplementation duration will be 12 weeks.The thylakoid and placebo sachets will be coded by the person responsible for preparing them, and the main investigators and the patients will be blinded to the type of the supplement each group receives.
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Participants/Inclusion and exclusion criteria
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48 women with polycystic ovary syndrome with BMI of 30-40 Kg/m2 will be included in the study. Pregnancy, lactation, and co-morbidity of other metabolic diseases are among the exclusion criteria of the study.
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Intervention groups
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The Individuals in both groups will receive a low-calorie diet considering their dietary habits. Patients in the thylakoid group will take a 5 gram thylakoid sachet with their lunch, daily. In the placebo group, the sachet will contain 5 grams of raw corn starch.
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Main outcome variables
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Anthropometric indices, body composition, insulin resistance index (HOMA-IR), components of metabolic syndrome, serum levels of free fatty acid, omentin, chemerin, hs-CRP, Neoptrin, FSH, LH, testosterone, SHBG and free androgen index(FAI).
General information
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Reason for update
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In order to need a precise interpretation of the mechanism of action of thylakoid in terms of metabolic, inflammatory, and hormonal effects in the study subjects, the measurement and evaluation of serum levels of these newly added parameters were considered necessary.
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Acronym
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ندارد
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IRCT registration information
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IRCT registration number:
IRCT20140907019082N9
Registration date:
2018-09-23, 1397/07/01
Registration timing:
registered_while_recruiting
Last update:
2021-02-01, 1399/11/13
Update count:
1
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Registration date
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2018-09-23, 1397/07/01
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-08-29, 1397/06/07
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Expected recruitment end date
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2018-12-21, 1397/09/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effects of oral thylakoid intake on the metabolic, hormonal and inflammatory parameters in obese women with polycystic ovary syndrome under hypocaloric diet: A randomized double-blinded placebo controlled trial
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Public title
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Effect of oral thylakoid intake with low-calorie diet in the treatment of polycystic ovary syndrome
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
All patients in our selected population were diagnosed with polycystic ovary syndrome according to Rotterdam diagnostic criteria with the diagnosis of the gynecologist.Having at least two of the three following symptoms:1-Abnormal menstrual cycles (oligomenorrhea, amenorrhea)2- Polycystic ovary in ultrasound3- Clinical signs of hyperandrogenism (Acne- Hirsutism) or biochemical symptoms of hyperandrogenism.
Women aged 20-40 years
Body Mass Index (BMI) range: 30-40 Kg/m2
Moderate activity level
Only OCP consumer (estrogen and progesterone combination pills). All participants will only receive OCP.
Willingness to participate in the study
Exclusion criteria:
Pregnancy(tendency to become pregnant) or lactation
Having any illness that affecting the studied variables (such as liver disease, thyroid disease, cardiovascular disease, renal disease, gastrointestinal disease , Cushing's syndrome,adrenal hyperplasia, androgen-secreting tumors , hyperprolactinemia).
Insulin infusion and intakes of blood pressure regulating drugs, statins and or drugs that affect insulin resistance (such as metformin), thiazolidinedione, anti androgens.
Using of any vitamin and mineral supplements and or antioxidants or being under certain diets at least two months before the study.
Any changes in the therapeutic protocol during the study
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Age
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From 20 years old to 45 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
48
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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From among the patients who volunteer to participate in the study, 48 individuals will be selected by simple randomization. Then by using the Random Allocation Software, the subjects will be allocated into either thylakoid or placebo group, stratified by age and body mass index (BMI).
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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In this study, the main investigators (including the student, and her supervisor and adviser professors) as well as the patients will be blinded to the type of the supplement (thylakoid or placebo) received by each group. The person responsible for preparing the supplement sachets (who is completely unrelated to the study) will be asked to assign a three digit code to each of the two powders (prebiotic and placebo), and keep the codes for himself until the end of the study and data analyses.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-08-27, 1397/06/05
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Ethics committee reference number
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IR.TBZMED.REC.1397.447
Health conditions studied
1
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Description of health condition studied
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Polycystic ovary syndrome
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ICD-10 code
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E28.2
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ICD-10 code description
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Polycystic ovarian syndrome
Primary outcomes
1
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Description
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Anthropometric indices
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Timepoint
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Baseline, middle of the study(sixth week) and 12 weeks after intervention
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Method of measurement
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Seca Scale, stadiometer and strip meter
2
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Description
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Body composition
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Timepoint
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Baseline, middle of the study(sixth week) and 12 weeks after intervention
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Method of measurement
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With the body composition analyzer
3
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Description
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Lipid profile
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Timepoint
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Baseline and 12 weeks after intervention
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Method of measurement
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Laboratory evaluation
4
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Description
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Fasting Blood Glucose (FBG)
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Timepoint
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Baseline and 12 weeks after intervention
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Method of measurement
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Laboratory evaluation
5
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Description
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Serum level of Insulin
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Timepoint
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Baseline and 12 weeks after intervention
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Method of measurement
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ELIZA
6
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Description
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Insulin resistance index
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Timepoint
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Baseline and 12 weeks after intervention
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Method of measurement
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Using formula
7
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Description
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Serum levels of free fatty acid (FFA)
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Timepoint
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Baseline and 12 weeks after intervention
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Method of measurement
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ELIZA
8
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Description
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Systolic and diastolic blood pressure
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Timepoint
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Baseline and 12 weeks after intervention
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Method of measurement
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manometer
9
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Description
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Serum level of chemerin
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Timepoint
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Baseline and 12 weeks after intervention
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Method of measurement
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ELIZA
10
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Description
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Serum level of Omentin
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Timepoint
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Baseline and 12 weeks after intervention
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Method of measurement
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ELIZA
11
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Description
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Inflammatory factors
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Timepoint
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Baseline and 12 weeks after intervention
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Method of measurement
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ELIZA
12
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Description
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Serum levels of testosterone
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Timepoint
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Baseline and 12 weeks after intervention
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Method of measurement
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ELIZA
13
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Description
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Serum levels of sex hormone binding glubolin (SHBG)
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Timepoint
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Baseline and 12 weeks after intervention
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Method of measurement
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ELIZA
14
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Description
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Serum levels of LH
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Timepoint
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Baseline and 12 weeks after intervention
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Method of measurement
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ELIZA
15
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Description
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Serum levels of FSH
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Timepoint
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Baseline and 12 weeks after intervention
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Method of measurement
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ELIZA
16
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Description
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Serum levels of DHEA-s
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Timepoint
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Baseline and 12 weeks after intervention
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Method of measurement
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ELIZA
Secondary outcomes
1
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Description
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serumic Sirtuin- 1
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Timepoint
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before and after of study
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Method of measurement
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ELISA
2
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Description
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Renal function parameters (serum levels of albumin, total protein, creatinine and blood urea nitrogen)
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Timepoint
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before and after of study
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Method of measurement
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Bromocresol Green(for Albumin), Creatinine (jaffe), others(colorimetric)
3
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Description
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TAC (total antioxidant capacity)
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Timepoint
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before and after of study
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Method of measurement
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Colorimetry (by spectrophotometry)
4
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Description
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Catalase
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Timepoint
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before and after of study
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Method of measurement
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Colorimetry (by spectrophotometry)
5
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Description
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MDA
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Timepoint
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before and after of study
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Method of measurement
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Colorimetry (by spectrophotometry)
6
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Description
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serum LPS
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Timepoint
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before and after of study
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Method of measurement
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ELISA
7
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Description
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serum Brain-Derived Neurotrophic Factor (BDNF)
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Timepoint
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before and after of study
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Method of measurement
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ELISA
8
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Description
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Serumic S100B
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Timepoint
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before and after of study
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Method of measurement
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ELISA
Intervention groups
1
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Description
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Intervention group: Patients in this group will receive low-calorie diet with a thylakoid supplement for 12 weeks. Thylakoid supplement is a sachet containing 5 grams of thylakoid (extracted from spinach leaves and made by a researcher) which will be dissolved in a glass of water and used once a day with lunch.
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Category
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Treatment - Drugs
2
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Description
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Control group: Patients in this group will receive low-calorie diet and placebo for 12 weeks. Placebo is a sachet containing 5 grams of raw corn starch, which will be dissolved in a glass of water and used once a day with lunch.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Vice chancellor for research , Tabriz University of Medical Sciences,
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Not applicable