CClinicalTrials.gg
Sign In
CompletedNCT04116203PCOSUpdated Feb 28, 2025

Dietary Fish Oil Intervention in Polycystic Ovary Syndrome (PCOS)

A Phase 1 interventional study of Metformin and Fish Oil and Metformin in Polycystic Ovary Syndrome and Lipid Metabolism Disorders, sponsored by University of Alberta. Completed at 2 sites in Canada. Open to female participants aged 18 Years to 30 Years. Per ClinicalTrials.gov, last updated 2025-02-28.

Sponsored by University of Alberta · Phase 1, Interventional, and Health services research

From the registry’s dates

  • Registered 1 year 10 months after the study started (first participant enrolled Jun 2016, registered May 2018).
Phase
Phase 1
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
Female
01

Study 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.

Read the 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.
02

Conditions studied

  • Polycystic Ovary Syndrome
  • Lipid Metabolism Disorders

Keywords

  • Polycystic Ovary Syndrome
  • metabolic and cardiovascular diseases
  • diabetes
  • obesity
03

In context

Polycystic Ovary Syndrome

944 studies on the registry are indexed under Polycystic Ovary Syndrome; 174 are open to participants now.

This study's enrollment of 52 is below the median of 70 across 685 interventional studies indexed under Polycystic Ovary Syndrome.

Browse Polycystic Ovary Syndrome studies →

Lead sponsor

University of Alberta is the lead sponsor of 800 studies on the registry; 168 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
52 participants (actual)

Study arms

  • Other
    Fish Oil

    Fish oil capsules 1200mg 6 tablets/day 12 weeks

    Dietary Supplement: Fish Oil

  • Other
    Metformin

    Metformin tablets (500 mg) 2/day 12 weeks

    Drug: Metformin

  • Other
    Fish Oil and Metformin

    Combo of other 2 arms

    Combination Product: Fish Oil and Metformin

Interventions

  • DrugMetformin

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

    Also known as: Metformin Hydrochloride Oral Antihyperglycemic Agent.

  • Combination productFish Oil and Metformin

    Combo of 2 other arms

  • Dietary supplementFish Oil

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

    Also known as: Fish Oil; Fish Oil 1200 Mg; Omega-3

06

What researchers measure

Primary outcomes

  1. 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

  1. Plasma insulin and glucose

    reported as mean +/- SEM

    Time frame: At baseline and postintervention at 12 weeks

  2. Plasma hormones, testosterone, SHBG, Estrogen

    reported as mean +/- SEM

    Time frame: At baseline and postintervention at 12 weeks

07

Study locations

2 sites
  • 9-111 Endocrinology Department, UofA Hospital
    Edmonton, Alberta T6G 2B7, Canada
  • 2-004 Li Ka Shing Centre, UofA
    Edmonton, Alberta T6G 2E1, Canada
08

References and documents

Publications

  • Vine DF, Wang Y, Jetha MM, Ball GD, Proctor SD. Impaired ApoB-Lipoprotein and Triglyceride Metabolism in Obese Adolescents With Polycystic Ovary Syndrome. J Clin Endocrinol Metab. 2017 Mar 1;102(3):970-982. doi: 10.1210/jc.2016-2854. PubMed 27997268 ↗

Individual participant data

Plan to share: No — There will be no sharing with other researchers.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04116203
Lead sponsor
University of Alberta
Collaborators
Women and Children's Health Research Institute, Canada, Canadian Institutes of Health Research (CIHR), Alberta Diabetes Institute, Heart and Stroke Foundation of Canada
Responsible party
Sponsor
First posted
Oct 4, 2019
Start date
Jun 30, 2016
Primary completion
Nov 12, 2020
Completion
Nov 12, 2020
Last update
Feb 28, 2025

Study contacts

Donna F Vine, PhD
principal investigator · Associate Professor

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Polycystic Ovary Syndrome→

Other studies from this sponsor

University of Alberta

Start the discussion