Mediterranean Diet with a Synbiotic Supplement for PCOS
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
Run by Atlas University · NCT07342946 · Data updated 2026-11-12
This study tests whether a reduced-calorie Mediterranean diet plus a synbiotic can improve health measures and quality of life for women with PCOS who are overweight or obese.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 45 Years |
| Sex | Women only |
| Enrollment | 32 (estimated) |
| Sponsor | Atlas University Academic / other |
| Locations | 1 site (Istanbul, Istanbul) |
| Status | Recruiting |
| Started | December 20, 2026 |
| Main results expected | April 1, 2027 |
| Study ends | August 1, 2027 |
| Registry record updated | October 28, 2026 |
| Trial ID | NCT07342946 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Premenopausal women aged 18-45 with BMI 25-35 kg/m² diagnosed with PCOS, not on special diets or certain medications, and without major comorbidities.
✕Probably not a fit
Individuals with uncontrolled metabolic diseases, recent pregnancy, or conditions requiring special diets may not benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, placebo-controlled, single-blind trial will assign overweight or obese premenopausal women with PCOS to receive either a synbiotic supplement or a placebo, while all participants follow a hypocaloric Mediterranean diet for 8 weeks. Researchers will measure body composition, weight-related metrics, and blood biomarkers at baseline and after 8 weeks, and will assess quality of life using the PCOSQ-50 questionnaire. The goal is to determine if adding synbiotic therapy to dietary treatment provides additional metabolic or quality-of-life benefits beyond diet alone.
Why it matters
Potential benefit: If successful, participants may see improved metabolic parameters and quality of life from the combined dietary and synbiotic approach.
How similar studies have gone: Previous work in related areas suggests potential benefits of synbiotics and diet on metabolic health, but results for PCOS remain exploratory and interventional evidence is evolving.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Atlas University
Istanbul, Istanbul, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Ayşenur Emirhuseyinoglu-Calik
- Email: ayse.emirhuseyinoglu@atlas.edu.tr
- Phone: +905315239218
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.