Status:
COMPLETED
Dietary Fish Oil Intervention in Polycystic Ovary Syndrome (PCOS)
Lead Sponsor:
University of Alberta
Collaborating Sponsors:
Women and Children's Health Research Institute, Canada
Canadian Institutes of Health Research (CIHR)
Conditions:
Polycystic Ovary Syndrome
Lipid Metabolism Disorders
Eligibility:
FEMALE
18-30 years
Phase:
PHASE1
Brief 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...
Detailed Description
Specific Objectives; 1. To determine the effect of dietary fish oil supplementation, metformin, and fish oil in combination with metformin on fasting and non-fasting plasma TG, apoB48 and apoB100-lip...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 30 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 12 2020
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04116203
Start Date
June 30 2016
End Date
November 12 2020
Last Update
February 28 2025
Active Locations (2)
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1
9-111 Endocrinology Department, UofA Hospital
Edmonton, Alberta, Canada, T6G 2B7
2
2-004 Li Ka Shing Centre, UofA
Edmonton, Alberta, Canada, T6G 2E1