NCT05272657

Brief Summary

This is a randomized controlled trial of two diets (low-carbohydrate and Mediterranean diet) in the treatment of women with polycystic ovary syndrome (PCOS). The trial assesses the effects of the two diets on clinical, metabolic and hormonal parameters, inflammatory markers and gut microbiota . This study is an interventional, randomized controlled trial, open-labeled.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 9, 2022

Completed
21 days until next milestone

Study Start

First participant enrolled

March 30, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

April 1, 2022

Status Verified

March 1, 2022

Enrollment Period

2 years

First QC Date

February 28, 2022

Last Update Submit

March 20, 2022

Conditions

Polycystic Ovary Syndrome (PCOS)

Keywords

microbiomeobesityMediterranean dietlow-carb diet

Outcome Measures

Primary Outcomes (2)

  • 1. Homeostasis Model Assessment for Insulin Resistance (HOMA-IR) index

    Changes in HOMA-IR index (fasting insulin \[mU/l\] \* fasting glucose \[mmol/L\]/22.5) after intervention

    12 weeks

  • 2. Free androgen index

    Changes in free androgen index \[ (total testosterone level / sex hormone binding globulin (SHBG) level) \* 100\].

    12 weeks

Secondary Outcomes (21)

  • 1. Total testosterone

    12 weeks

  • 2. Androstenedione

    12 weeks

  • 3. Anti-Müllerian hormone (AMH)

    12 weeks

  • 4. 17-Hydroxyprogesterone (17-OH-progesterone)

    12 weeks

  • 5. Luteinizing hormone (LH)

    12 weeks

  • +16 more secondary outcomes

Study Arms (2)

low-carbohydrate diet

EXPERIMENTAL

subjects in this arm are given detailed instructions and coaching in following a low-carbohydrate diet.

Other: low-carbohydrate diet

Mediterranean diet

EXPERIMENTAL

subjects in this arm are given detailed instructions and coaching in following a Mediterranean diet.

Other: Mediterranean diet

Interventions

low-carbohydrate dietOTHER

subjects in this arm are given detailed instructions and coaching in following a low-carbohydrate diet.

low-carbohydrate diet
Mediterranean dietOTHER

subjects in this arm are given detailed instructions and coaching in following a Mediterranean diet.

Mediterranean diet

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women with PCOS between the ages of 18-40 years and with a body mass index of less than or equal to 45.
  • Fulfillment of at least two of the following three criteria for PCOS, adopted by the Rotterdam Consensus in 2003 (Rotterdam ESHRE / ASRM-Sponsored PCOS Consensus Workshop Group):
  • signs of hyperandrogenemia - clinical and / or biochemical (increase in the index of free androgens or total testosterone)
  • signs of chronic anovulation
  • ultrasound signs: the number of follicles in the ovary ≥ 20 and / or ovarian volume ≥ 10 ml in any ovary in the case of gynecological age 8 or more years after menarche.

You may not qualify if:

  • The presence of hyperprolactinemia
  • Cushing's syndrome
  • Ongenital hyperplasia of the adrenal cortex
  • Hypothyroidism
  • Androgen-producing tumors
  • Regular use of drugs and dietary supplements that affect the function of the ovaries
  • Adrenal glands
  • Metabolism of carbohydrates
  • Lipids
  • Microbiota composition during the 2 months preceding the study
  • Pregnancy
  • Lactation
  • Significant comorbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Polycystic Ovary SyndromeObesity

Interventions

Diet, Carbohydrate-RestrictedDiet, Mediterranean

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaDiet, Plant-Based

Study Officials

  • Polina Popova, MD,PhD

    Almazov National Medical Research Centre

    STUDY CHAIR

Central Study Contacts

Polina Popova, MD,PhD

CONTACT

702-55-95pvpopova@yandex.ru

Elena Vasiukova

CONTACT

elenavasukova2@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2022

First Posted

March 9, 2022

Study Start

March 30, 2022

Primary Completion

March 30, 2024

Study Completion

June 30, 2024

Last Updated

April 1, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share