Clinical trial

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

Opening soon · Not applicable · 0 countries · Registry ID NCT07342946

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 45 Years

SexFemale

Healthy volunteersNot accepted

ConditionPCOS (Polycystic Ovary Syndrome)

Full registry 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or current use of medications that may affect fluid balance, including diuretics and laxatives * Participants will be withdrawn from the study in case of abnormal biochemical parameters, non-adherence to the prescribed diet, or failure to comply with the supplementation protoco

Treatments and study arms

Synbiotic Supplement

Dietary Supplement

Participants in this arm will receive a hypocaloric Mediterranean diet in addition to synbiotic supplementation for a period of 8 weeks.

Placebo

Other

Participants in this arm will receive a hypocaloric Mediterranean diet in addition to a placebo for a period of 8 weeks.

Primary outcomes

Change in body weightFrom enrollment to the end of treatment at 8 weeks

Changes in body weight measured in kilograms using the Tanita MC-780 bioelectrical impedance analysis (BIA) device at baseline and after the 8-week intervention.

Change in body mass index (BMI)From enrollment to the end of treatment at 8 weeks

Changes in body mass index (BMI), calculated as weight in kilograms divided by height in meters squared (kg/m²), with body weight measured using the Tanita MC-780 bioelectrical impedance analysis (BIA) device at baseline and after the 8-week intervention.

Change in body compositionFrom enrollment to the end of treatment at 8 weeks

Changes in body composition parameters, including fat mass and fat-free mass, assessed using the Tanita MC-780 bioelectrical impedance analysis (BIA) device at baseline and after the 8-week intervention.

Change in waist circumferenceFrom enrollment to the end of treatment at 8 weeks

Changes in waist circumference measured in centimeters using a non-elastic measuring tape at baseline and after the 8-week intervention.

Change in hip circumferenceFrom enrollment to the end of treatment at 8 weeks

Changes in hip circumference measured in centimeters using a non-elastic measuring tape at baseline and after the 8-week intervention.

Study locations

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No public site location was included in this record. Check the original registry for updates.