Dietary Fish Oil Intervention in Polycystic Ovary Syndrome (PCOS)

• Status: Suspended
• Trial end date: 2020-07-30
• Target enrollment: 0
• Participant gender: Female

Summary

The primary objective in this proposed study is to determine the effect of dietary fish oil supplementation compared to standard care metformin treatment, and fish oil in combination with metformin on plasma lipids and apoB-remnant lipoprotein metabolism in overweight-obese young women with PCOS.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alberta
• Collaborators: Alberta Diabetes Institute; Canadian Institutes of Health Research (CIHR); Women and Children's Health Research Institute, Canada
• Treatments: Hypoglycemic Agents; Metformin

Criteria

Inclusion Criteria:

• Female

• Age at time of enrollment > 18 to <30 years

• Diagnosis of PCOS: clinical and/or biochemical hyperandrogenemia and menstrual dysfunction and the exclusion of other disorders.

• Overweight-obese (BMI >25 kg/m2) high-risk metabolically-resistant young women.

• Elevated fasting plasma TG (>150 mg/dL) and 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

• Lactating women

• Recent illness that the investigator determines to pose a potential risk for the participant

• Concomitant medications that influence metabolism (e.g. statins)

• Excessive alcohol consumption, as determined by the investigator.