Dietary Fish Oil Intervention in Polycystic Ovary Syndrome (PCOS)

University of Alberta52 enrolled

Overview

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.

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-lipoprotein concentrations. 2. 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. 3. 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Polycystic Ovary Syndrome Lipid Metabolism Disorders

Interventions

MetforminDRUG

Manufacturer's standard 500 mg. Submission Control No.:128147

Fish Oil and MetforminCOMBINATION_PRODUCT

Combo of 2 other arms

Fish OilDIETARY_SUPPLEMENT

NPN: 80028808 Licence Holder: WN Pharmaceuticals Ltd Dosage Form: Capsule, soft Recommended Route of Administration: Oral

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 30 Years

Medical Language ↔ Plain English

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.

Locations (2)

9-111 Endocrinology Department, UofA Hospital

Edmonton, Alberta, Canada

2-004 Li Ka Shing Centre, UofA

Edmonton, Alberta, Canada

Outcomes

Primary Outcomes

Plasma Triglycerides and apoB-lipoprotein remnants in non-fasting and fasted state

reported as mean +/- SEM

Time frame: At baseline and postintervention at 12 weeks

Secondary Outcomes

Plasma insulin and glucose

reported as mean +/- SEM

Time frame: At baseline and postintervention at 12 weeks

Plasma hormones, testosterone, SHBG, Estrogen

reported as mean +/- SEM

Time frame: At baseline and postintervention at 12 weeks

Data from ClinicalTrials.gov

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