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NCT Number: NCT07342946

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

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.

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Key information

Conditions

PCOS (Polycystic Ovary Syndrome) Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Polycystic Ovary Syndrome Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Mediterrenean Diet

Placebo

Other

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

Other names: Mediterrenean Diet

Primary outcomes

  1. Change in body weight

    Time frame: From 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.

  2. Change in body mass index (BMI)

    Time frame: 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.

  3. Change in body composition

    Time frame: From 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.

  4. Change in waist circumference

    Time frame: From 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.

  5. Change in hip circumference

    Time frame: From 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.

Secondary outcomes

  1. Change in insulin resistance (HOMA-IR)

    Time frame: From enrollment to the end of treatment at 8 weeks

    Changes in insulin resistance assessed using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), calculated from fasting plasma glucose and fasting insulin levels. A HOMA-IR value below 2.5 will be considered indicative of the absence of insulin resistance. Measurements will be performed at baseline and after the 8-week intervention.

  2. Change in fasting blood glucose

    Time frame: From enrollment to the end of treatment at 8 weeks

    Changes in fasting blood glucose levels measured in mg/dL from venous blood samples collected at baseline and after the 8-week intervention.

  3. Change in lipid profile

    Time frame: From enrollment to the end of treatment at 8 weeks

    Changes in serum lipid profile parameters, including high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), triglycerides (TG), and total cholesterol, measured in mg/dL from venous blood samples collected at baseline and after the 8-week intervention.

  4. Change in follicle-stimulating hormone (FSH) levels

    Time frame: From enrollment to the end of treatment at 8 weeks

    Changes in serum follicle-stimulating hormone (FSH) levels measured from venous blood samples collected at baseline and after the 8-week intervention.

  5. Change in luteinizing hormone (LH) levels

    Time frame: From enrollment to the end of treatment at 8 weeks

    Changes in serum luteinizing hormone (LH) levels measured from venous blood samples collected at baseline and after the 8-week intervention.

  6. Change in quality of life

    Time frame: From enrollment to the end of treatment at 8 weeks

    Changes in quality of life assessed using the Polycystic Ovary Syndrome Quality of Life Questionnaire (PCOSQ-50), a validated disease-specific instrument consisting of 50 items across six domains: psychosocial and emotional well-being, fertility, sexual function, obesity and menstrual irregularity, hirsutism, and coping with the disease. Each item is scored on a 5-point Likert scale ranging from 1 (always) to 5 (never), resulting in a total score range of 50 to 250. Higher scores indicate better quality of life. Domain scores are calculated as the mean of the items answered within each domain, excluding unanswered items. Assessments will be performed at baseline and after the 8-week intervention.

Study contacts

Contact information is provided by the study sponsor or research team.

Ayşenur Emirhuseyinoglu-Calik

CONTACT

[email protected]

+905315239218

Sponsors and collaborators

Lead sponsor

Atlas University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 15, 2026
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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