NCT06424860

Fish Oil, Metformin and Heart Health in PCOS

Dietary Fish Oil and Metformin Intervention for Heart Health in PCOS

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 146 (estimated)
• Sponsor: University of Alberta · Academic / Other
• Sex: Female
• Age: 25 Years – 45 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• PCOS
• Cardiovascular Disease
• Atherosclerotic Cardiovascular Disease
• Atherosclerotic Plaque
• Cardiac Hypertrophy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Fish oil	For 12 months
DRUG	Metformin	12 months
COMBINATION_PRODUCT	Fish Oil and Metformin	12 months

Timeline

• Start date: 2025-11-01
• Primary completion: 2026-12-30
• Completion: 2027-12-30
• First posted: 2024-05-22
• Last updated: 2025-12-12

Locations

3 sites across 1 country: Canada