Dietary Fish Oil Intervention in Polycystic Ovary Syndrome (PCOS)

Phase 1

Completed

• Conditions: Lipid Metabolism Disorders; Polycystic Ovary Syndrome
• Interventions: Combination Product: Fish Oil and Metformin; Dietary Supplement: Fish Oil; Drug: Metformin

• Registration Number: NCT04116203
• Lead Sponsor: University of Alberta

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 plasma lipids and apoB-remnant lipoprotein metabolism in overweight-obese young women with PCOS.

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-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 Timeline

• Study Start: 2016-06-30
• Study First Submitted: 2018-05-05
• Study First Submitted QC: 2019-10-02
• Study First Posted: 2019-10-04
• Primary Completion: 2020-11-12
• Study Completion: 2020-11-12
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 52

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fish Oil and Metformin	Fish Oil and Metformin	Combo of other 2 arms
Fish Oil	Fish Oil	Fish oil capsules 1200mg 6 tablets/day 12 weeks
Metformin	Metformin	Metformin tablets (500 mg) 2/day 12 weeks

Primary Outcome Measures

Name	Time	Method
Plasma Triglycerides and apoB-lipoprotein remnants in non-fasting and fasted state	At baseline and postintervention at 12 weeks	reported as mean +/- SEM

Secondary Outcome Measures

Name	Time	Method
Plasma hormones, testosterone, SHBG, Estrogen	At baseline and postintervention at 12 weeks	reported as mean +/- SEM
Plasma insulin and glucose	At baseline and postintervention at 12 weeks	reported as mean +/- SEM

Trial Locations

Locations (2)

9-111 Endocrinology Department, UofA Hospital; 🇨🇦 Edmonton, Alberta, Canada

2-004 Li Ka Shing Centre, UofA; 🇨🇦 Edmonton, Alberta, Canada