Fish Oil, Metformin and Heart Health in PCOS

December 4, 2025 updated by: University of Alberta

Dietary Fish Oil and Metformin Intervention for Heart Health in PCOS

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES The objective in this proposed study is to determine the effect of dietary fish oil supplementation with metformin compared to standard of care metformin-alone treatment for 12 months on plasma lipids and apoB- remnant lipoprotein metabolism, and atherosclerotic cardiovascular disease and cardiac function in high-risk overweight-obese young individuals with PCOS.

This study will provide evidence-based research on the efficacy of fish oil, in the form as an adjunct therapy to standard treatment with metformin, as a safe nutritional treatment to add to therapeutic guidelines to reduce early CVD risk in young women with PCOS.

Specific Objectives;

  1. To quantify carotid intimal medical thickness (cIMT) and plaque height before and after the intervention to assess the effect of fish oil supplementation combined with metformin standard of care on atherosclerotic cardiovascular disease and cardiac function.
  2. To determine the effects of dietary fish oil supplementation combined with metformin and metformin standard of care on fasting and non-fasting plasma TG, apoB48 and apoB100-lipoprotein concentrations, and cardiac function variables including left ventricular (LV) posterior wall thickness, LV ejection fraction.
  3. To assess the effect of dietary fish oil supplementation on insulin, glucose, and endocrine parameters.

Study Type

Interventional

Enrollment (Estimated)

146

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2E1
        • Recruiting
        • Human Nutrition Research Unit - Li Ka Shing Health Research Center
        • Contact:
        • Contact:
      • Edmonton, Alberta, Canada, T6G-2B7
        • Recruiting
        • Mazankowski Alberta Heart Institute
        • Contact:
        • Contact:
      • Edmonton, Alberta, Canada, T6G-2B7
        • Recruiting
        • University of Alberta Hospital - Division of Endocrinology
        • Contact:
        • Contact:
          • Beate Sydora

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • diagnosis of PCOS
  • overweight-obese (BMI >25 kg/m2)
  • elevated fasting plasma TG (>150 mg/dL)
  • and/or apoB48-remnant cholesterol lipoproteins (>20 ug/ml)
  • impaired insulin sensitivity (glucose 100-125 mg/dL and/or insulin >15 (uM/ml), and may be diagnosed with T2D (blood glucose >126 mg/dL).

Exclusion Criteria:

-pregnancy, lactation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Metformin
metformin (1500mg/d) and placebo (olive oil capsule)
Drug: Metformin
12 months
Experimental: Fishoil and metformin
metformin (1500mg/d) and fish oil (4000mg/d)
Dietary supplement: Fish oil
For 12 months
Combination product: Fish Oil and Metformin
12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Carotid intimal medial thickness
Time Frame: 12 months
mm
12 months
carotid plaque height
Time Frame: 12 months
mm
12 months
Left ventricular global longitudinal strain (LVGLS)
Time Frame: 12 months
percent change in LVGLS
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood lipids
Time Frame: 12 months
TG, LDL-C, HDL-C, non-HDL-C mmol/l
12 months
ApoB-lipoproteins
Time Frame: 12 months
apob48 and apoB100 mg/l
12 months
remnant-cholesterol
Time Frame: 12 months
mmol/l
12 months
Testosterone
Time Frame: 12 months
nmol/l
12 months
insulin
Time Frame: 12 months
pmol/l
12 months
glucose
Time Frame: 12 months
mmol/l
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Collaborators

Heart and Stroke Foundation of Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2025

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

April 29, 2024

First Submitted That Met QC Criteria

May 16, 2024

First Posted (Actual)

May 22, 2024

Study Record Updates

Last Update Posted (Actual)

December 12, 2025

Last Update Submitted That Met QC Criteria

December 4, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00141704

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

no plan

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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