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NCT Number: NCT06424860

Fish Oil, Metformin and 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.

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Key information

Age range

25 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Human Nutrition Research Unit - Li Ka Shing Health Research Center, Edmonton, Alberta, Canada

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About this study

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;

  • 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.
  • 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.
  • To assess the effect of dietary fish oil supplementation on insulin, glucose, and endocrine parameters.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fish Oil

Dietary Supplement

For 12 months

metformin

Drug

12 months

Fish Oil and Metformin

Combination Product

12 months

Primary outcomes

  1. Carotid intimal medial thickness

    Time frame: 12 months

    mm

  2. carotid plaque height

    Time frame: 12 months

    mm

  3. Left ventricular global longitudinal strain (LVGLS)

    Time frame: 12 months

    percent change in LVGLS

Secondary outcomes

  1. Blood lipids

    Time frame: 12 months

    TG, LDL-C, HDL-C, non-HDL-C mmol/l

  2. ApoB-lipoproteins

    Time frame: 12 months

    apob48 and apoB100 mg/l

  3. remnant-cholesterol

    Time frame: 12 months

    mmol/l

  4. Testosterone

    Time frame: 12 months

    nmol/l

  5. insulin

    Time frame: 12 months

    pmol/l

  6. glucose

    Time frame: 12 months

    mmol/l

Study contacts

Contact information is provided by the study sponsor or research team.

Donna Vine, PhD

CONTACT

[email protected]

780-492-4393

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Heart and Stroke Foundation of Canada

Registry information

Official study title

Dietary Fish Oil and Metformin Intervention for Heart Health in PCOS

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
May 22, 2024
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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