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Fish Oil, Metformin and Heart Health in PCOS

NCT06424860 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2025-12-12

No results posted yet for this study

Summary

Women with Polycystic Ovary Syndrome (PCOS) have high testosterone levels which is associated with altered insulin-glucose metabolism and an adverse blood lipid profile, predisposing them to the development of Type II Diabetes and Cardiovascular Disease (CVD). This study will investigate the use of dietary fish oil supplementation as a safe and effective intervention, and as an adjunct therapy to standard of care treatment with metformin to improve heart health, blood lipids and insulin-glucose metabolism in women with PCOS, and those with PCOS and Type 2 Diabetes.

Conditions

Interventions

DIETARY_SUPPLEMENT

Fish oil

For 12 months

DRUG

Metformin

12 months

COMBINATION_PRODUCT

Fish Oil and Metformin

12 months

Sponsors & Collaborators

  • Heart and Stroke Foundation of Canada

    collaborator OTHER

  • University of Alberta

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-01
Primary Completion
2026-12-30
Completion
2027-12-30

Countries

  • Canada

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06424860 on ClinicalTrials.gov