NCT04116203

Dietary Fish Oil Intervention in Polycystic Ovary Syndrome (PCOS)

Dietary Fish Oil Intervention in Polycystic Ovary Syndrome

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: University of Alberta · Academic / Other
• Sex: Female
• Age: 18 Years – 30 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Polycystic Ovary Syndrome
• Lipid Metabolism Disorders

Interventions

Type	Name	Description
DRUG	Metformin	Manufacturer's standard 500 mg. Submission Control No.:128147
COMBINATION_PRODUCT	Fish Oil and Metformin	Combo of 2 other arms
DIETARY_SUPPLEMENT	Fish Oil	NPN: 80028808 Licence Holder: WN Pharmaceuticals Ltd Dosage Form: Capsule, soft Recommended Route of Administration: Oral

Timeline

• Start date: 2016-06-30
• Primary completion: 2020-11-12
• Completion: 2020-11-12
• First posted: 2019-10-04
• Last updated: 2025-02-28

Locations

2 sites across 1 country: Canada