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Effect of oral thylakoid intake with low-calorie diet in the treatment of polycystic ovary syndrome

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20140907019082N9
Enrollment
48
Registered
2018-09-23
Start date
2018-08-29
Completion date
Unknown
Last updated
2021-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic ovary syndrome. Polycystic ovarian syndrome

Interventions

Intervention 1: 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 (ext

Sponsors

Vice chancellor for research , Tabriz University of Medical Sciences,
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 45 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Anthropometric indices. Timepoint: Baseline, middle of the study(sixth week) and 12 weeks after intervention. Method of measurement: Seca Scale, stadiometer and strip meter.;Body composition. Timepoint: Baseline, middle of the study(sixth week) and 12 weeks after intervention. Method of measurement: With the body composition analyzer.;Lipid profile. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Laboratory evaluation.;Fasting Blood Glucose (FBG). Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Laboratory evaluation.;Serum level of Insulin. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELIZA.;Insulin resistance index. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Using formula.;Serum levels of free fatty acid (FFA). Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELIZA.;Systolic and diastolic blood pressure. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: manometer.;Serum level of chemerin. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELIZA.;Serum level of Omentin. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELIZA.;Inflammatory factors. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELIZA.;Serum levels of testosterone. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELIZA.;Serum levels of sex hormone binding glubolin (SHBG). Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELIZA.;Serum levels of LH. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELIZA.;Serum levels of FSH. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELIZA.;Serum levels of DHEA-s. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELIZA.

Secondary

MeasureTime frame
Serumic Sirtuin- 1. Timepoint: before and after of study. Method of measurement: ELISA.;Renal function parameters (serum levels of albumin, total protein, creatinine and blood urea nitrogen). Timepoint: before and after of study. Method of measurement: Bromocresol Green(for Albumin), Creatinine (jaffe), others(colorimetric).;TAC (total antioxidant capacity). Timepoint: before and after of study. Method of measurement: Colorimetry (by spectrophotometry).;Catalase. Timepoint: before and after of study. Method of measurement: Colorimetry (by spectrophotometry).;MDA. Timepoint: before and after of study. Method of measurement: Colorimetry (by spectrophotometry).;Serum LPS. Timepoint: before and after of study. Method of measurement: ELISA.;Serum Brain-Derived Neurotrophic Factor (BDNF). Timepoint: before and after of study. Method of measurement: ELISA.;Serumic S100B. Timepoint: before and after of study. Method of measurement: ELISA.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh Pourteymour Fard Tabrizi

Tabriz University of Medical Sciences

Fateme.Pourteymour@gmail.com+98 41 3335 7582

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 26, 2026