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

NCT ID: NCT07342946

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-20
• Study Completion Date: 2027-08-01

Brief Summary

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.

Conditions

PCOS (Polycystic Ovary Syndrome)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Synbiotics

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

Group Type: ACTIVE_COMPARATOR

Synbiotic Supplement

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Synbiotic Supplement

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: OTHER

Other Intervention Names

Mediterrenean Diet; Mediterrenean Diet

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Atlas University

OTHER

Sponsor Role: lead

Responsible Party

Aysenur Emirhuseyinoglu Calik

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Derya Sivri-Aydın

Role: STUDY_DIRECTOR

Atlas University

Central Contacts

Ayşenur Emirhuseyinoglu-Calik

Role: CONTACT

ayse.emirhuseyinoglu@atlas.edu.tr

+905315239218

References

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.

Reference Type: BACKGROUND

PMID: 38172876 (View on PubMed)

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.

Reference Type: BACKGROUND

Other Identifiers

E-22686390-050.99-78501

Identifier Type: -

Identifier Source: org_study_id