Dietary Fish Oil and Metformin Intervention for Heart Health in PCOS

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug, Dietary supplement, Combination product
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: Female
Minimum Age: 25
Maximum Age: 45
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Canada
Human Nutrition Research Unit - Li Ka Shing Health Research Center
RECRUITING
Edmonton
Mazankowski Alberta Heart Institute
RECRUITING
Edmonton
University of Alberta Hospital - Division of Endocrinology
RECRUITING
Edmonton
Contact Information
Primary
Donna Vine, PhD
dvine@ualberta.ca
780-492-4393
Time Frame
Start Date: 2025-11-01
Estimated Completion Date: 2027-12-30
Participants
Target number of participants: 146
Treatments
Active_comparator: Metformin
metformin (1500mg/d) and placebo (olive oil capsule)
Experimental: Fishoil and metformin
metformin (1500mg/d) and fish oil (4000mg/d)
Sponsors
Collaborators: Heart and Stroke Foundation of Canada
Leads: University of Alberta

This content was sourced from clinicaltrials.gov