NCT07342946

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
15mo left

Started Dec 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress24%
Dec 2025Aug 2027

Study Start

First participant enrolled

December 20, 2025

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 23, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 15, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

1.3 years

First QC Date

December 23, 2025

Last Update Submit

January 6, 2026

Conditions

PCOS (Polycystic Ovary Syndrome)

Keywords

synbioticspcosdietnutrition

Outcome Measures

Primary Outcomes (5)

  • Change in body weight

    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.

    From enrollment to the end of treatment at 8 weeks

  • Change in body mass index (BMI)

    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.

    From enrollment to the end of treatment at 8 weeks

  • Change in body composition

    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.

    From enrollment to the end of treatment at 8 weeks

  • Change in waist circumference

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

    From enrollment to the end of treatment at 8 weeks

  • Change in hip circumference

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

    From enrollment to the end of treatment at 8 weeks

Secondary Outcomes (6)

  • Change in insulin resistance (HOMA-IR)

    From enrollment to the end of treatment at 8 weeks

  • Change in fasting blood glucose

    From enrollment to the end of treatment at 8 weeks

  • Change in lipid profile

    From enrollment to the end of treatment at 8 weeks

  • Change in follicle-stimulating hormone (FSH) levels

    From enrollment to the end of treatment at 8 weeks

  • Change in luteinizing hormone (LH) levels

    From enrollment to the end of treatment at 8 weeks

  • +1 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Synbiotics

ACTIVE COMPARATOR

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

Dietary Supplement: Synbiotic Supplement

Interventions

Synbiotic SupplementDIETARY_SUPPLEMENT

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

Also known as: Mediterrenean Diet
Synbiotics
PlaceboOTHER

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

Also known as: Mediterrenean Diet
Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 38172876BACKGROUND

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Derya Sivri-Aydın

    Atlas University

    STUDY DIRECTOR

Central Study Contacts

Ayşenur Emirhuseyinoglu-Calik

CONTACT

+905315239218ayse.emirhuseyinoglu@atlas.edu.tr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

December 23, 2025

First Posted

January 15, 2026

Study Start

December 20, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

January 15, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share