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Completed

NCT Number: NCT04116203

Dietary Fish Oil Intervention in Polycystic Ovary Syndrome (PCOS)

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.

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Key information

About this study

Specific Objectives;

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

metformin

Drug

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

Other names: Metformin Hydrochloride Oral Antihyperglycemic Agent.

Fish Oil and Metformin

Combination Product

Combo of 2 other arms

Fish Oil

Dietary Supplement

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

Other names: Fish Oil; Fish Oil 1200 Mg; Omega-3

Primary outcomes

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

    Time frame: At baseline and postintervention at 12 weeks

    reported as mean +/- SEM

Secondary outcomes

  1. Plasma insulin and glucose

    Time frame: At baseline and postintervention at 12 weeks

    reported as mean +/- SEM

  2. Plasma hormones, testosterone, SHBG, Estrogen

    Time frame: At baseline and postintervention at 12 weeks

    reported as mean +/- SEM

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Alberta Diabetes Institute
  • Canadian Institutes of Health Research (CIHR)
  • Heart and Stroke Foundation of Canada
  • Women and Children's Health Research Institute, Canada

Registry information

Official study title

Dietary Fish Oil Intervention in Polycystic Ovary Syndrome

Acronym: PCOS

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Oct 4, 2019
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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