The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Synbiotic Supplement, Placebo.
- Who it may be relevant to
- Registry conditions: PCOS (Polycystic Ovary Syndrome). Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effects of a Mediterranean Diet and Synbiotic Supplementation on Anthropometric and Biochemical Parameters and Quality of Life in Obese Women With Polycystic Ovary Syndrome
Overview
This study will look at whether a reduced-calorie Mediterranean-style eating plan, together with a synbiotic supplement, can improve health measures and quality of life in women who have polycystic ovary syndrome (PCOS) and are overweight or have obesity. Participants will be assigned by chance (like flipping a coin) to receive either the synbiotic supplement or a placebo (a look-alike product with no active ingredients). All participants will follow the same reduced-calorie Mediterranean diet for 8 weeks. The study team will measure body composition and weight-related measurements, and will collect blood samples to evaluate selected laboratory markers before and after the 8-week period. Participants will also complete the PCOSQ-50 quality-of-life questionnaire before and after the intervention. The goal is to better understand the possible role of synbiotic supplementation alongside dietary treatment in PCOS.
Detailed description
This randomized, placebo-controlled, single-blind clinical trial is designed to evaluate the effects of a hypocaloric Mediterranean diet combined with synbiotic supplementation on anthropometric measurements, biochemical parameters, and quality of life in overweight and obese women diagnosed with polycystic ovary syndrome (PCOS). Eligible participants will be randomly assigned to one of two study arms: a synbiotic supplementation group or a placebo group. Both groups will follow the same hypocaloric Mediterranean diet throughout the 8-week intervention period.
Anthropometric assessments, including body weight, body mass index, waist circumference, and body composition, will be performed at baseline and at the end of the intervention. Biochemical parameters will be evaluated through blood samples collected at baseline and after 8 weeks. Quality of life will be assessed using the PCOSQ-50 Quality of Life Questionnaire at both time points.
The study aims to determine whether the addition of synbiotic supplementation to a hypocaloric Mediterranean diet provides additional benefits in the management of PCOS-related metabolic parameters and quality of life compared with dietary intervention alone.
Interventions
- Dietary supplement Synbiotic Supplement
Participants in this arm will receive a hypocaloric Mediterranean diet in addition to synbiotic supplementation for a period of 8 weeks. - Other Placebo
Participants in this arm will receive a hypocaloric Mediterranean diet in addition to a placebo for a period of 8 weeks.
Primary outcome measures
- Change in body weight [Time frame: From enrollment to the end of treatment at 8 weeks]
- Change in body mass index (BMI) [Time frame: From enrollment to the end of treatment at 8 weeks]
- Change in body composition [Time frame: From enrollment to the end of treatment at 8 weeks]
- Change in waist circumference [Time frame: From enrollment to the end of treatment at 8 weeks]
- Change in hip circumference [Time frame: From enrollment to the end of treatment at 8 weeks]
Secondary outcome measures (6)
- Change in insulin resistance (HOMA-IR) [Time frame: From enrollment to the end of treatment at 8 weeks]
- Change in fasting blood glucose [Time frame: From enrollment to the end of treatment at 8 weeks]
- Change in lipid profile [Time frame: From enrollment to the end of treatment at 8 weeks]
- Change in follicle-stimulating hormone (FSH) levels [Time frame: From enrollment to the end of treatment at 8 weeks]
- Change in luteinizing hormone (LH) levels [Time frame: From enrollment to the end of treatment at 8 weeks]
- Change in quality of life [Time frame: From enrollment to the end of treatment at 8 weeks]
Eligibility criteria
Inclusion criteria
- Premenopausal women who are overweight or obese, with a body mass index (BMI) between 25 and 35 kg/m²
- Aged 18 to 45 years (reproductive age)
- Diagnosed with polycystic ovary syndrome (PCOS)
No underlying metabolic diseases, including type 2 diabetes mellitus, hypertension, diagnosed anemia, or any other metabolic condition requiring a special diet
Exclusion criteria
- Pregnancy or breastfeeding within the past 6 months
- Presence of comorbid conditions, including kidney, liver, or cardiovascular disease, gout, hyperuricemia, or other related disorders
- Use of oral contraceptives
- Following a special dietary treatment or a hypocaloric diet within the last 3 months
- Occasional or current use of medications that may affect fluid balance, including diuretics and laxatives
- Participants will be withdrawn from the study in case of abnormal biochemical parameters, non-adherence to the prescribed diet, or failure to comply with the supplementation protoco
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Hariri Z, Yari Z, Hoseini S, Abhari K, Sohrab G. Synbiotic as an ameliorating factor in the health-related quality of life in women with polycystic ovary syndrome. A randomized, triple-blind, placebo-controlled trial. BMC Womens Health. 2024 Jan 3;24(1):19. doi: 10.1186/s12905-023-02868-1. PMID 38172876
- Koyutürk, G., & Külünkoğlu, B. A. (2023). Polikistik Over Sendromu Yaşam Kalitesi-50 Ölçeği'nin Türkçe uyarlamasının geçerlik ve güvenirliği. Sağlık ve Yaşam Bilimleri Dergisi, 5(2), 63-70.
Identifiers
NCT: NCT07342946 · E-22686390-050.99-78501