Dietary Fish Oil Intervention in Polycystic Ovary Syndrome (PCOS)
Dietary Fish Oil Intervention in Polycystic Ovary Syndrome
Lead SponsorUniversity of Alberta
Indication/ConditionPolycystic Ovary Syndrome Lipid Metabolism Disorders
Intervention/TreatmentMetformin Fish Oil and Metformin [fish oil (113717), metformin (724)] Fish Oil
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.
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-lipoprotein concentrations.
To determine the physiological mechanisms associated with the effect of dietary fish oil supplementation and metformin on in vivo plasma lipid and apoB-lipoprotein kinetics. We will quantitate the in vivo production and kinetics of plasma TG, apoB48 and apoB100-lipoproteins in plasma and isolated lipoprotein fractions, using established methods.
To explore the effects of dietary fish oil supplementation, metformin and fish oil in combination with metformin, on plasma insulin and testosterone, and the association with changes in plasma lipids and apoB-lipoprotein metabolism.
Manufacturer's standard 500 mg. Submission Control No.:128147
Combo of 2 other arms
NPN: 80028808 Licence Holder: WN Pharmaceuticals Ltd Dosage Form: Capsule, soft Recommended Route of Administration: Oral
Fish oil capsules 1200mg 6 tablets/day 12 weeks
Metformin tablets (500 mg) 2/day 12 weeks
Combo of other 2 arms
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.