RecruitingPhase 1NCT06424860

Fish Oil, Metformin and Heart Health in PCOS

Dietary Fish Oil and Metformin Intervention for Heart Health in PCOS


Sponsor

University of Alberta

Enrollment

146 participants

Start Date

Nov 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 25 YearsMax Age: 45 Years

Inclusion Criteria5

  • 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 Criteria1

  • pregnancy, lactation

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Interventions

DIETARY_SUPPLEMENTFish oil

For 12 months

DRUGMetformin

12 months

COMBINATION_PRODUCTFish Oil and Metformin

12 months


Locations(3)

Human Nutrition Research Unit - Li Ka Shing Health Research Center

Edmonton, Alberta, Canada

Mazankowski Alberta Heart Institute

Edmonton, Alberta, Canada

University of Alberta Hospital - Division of Endocrinology

Edmonton, Alberta, Canada

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NCT06424860


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