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The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome

RecruitingNAAges 18 Years - 45 YearsFemaleAtlas University
NCT07342946 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 die

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📋 Eligibility rules (as published)
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or current use of medications that may affect fluid balance, including diuretics and laxatives * Participants will be withdrawn from the study in case of abnormal biochemical parameters, non-adherence to the prescribed diet, or failure to comply with the supplementation protoco
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What it tests

  • Synbiotic Supplement
  • Placebo
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Where

1 site
Atlas University
Istanbul, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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