Dietary Fish Oil Intervention in Polycystic Ovary Syndrome (PCOS) (PCOS)

Dietary Fish Oil Intervention in Polycystic Ovary Syndrome

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.

Study Overview

• Status: Suspended
• Conditions: Polycystic Ovary Syndrome; Lipid Metabolism Disorders
• Intervention / Treatment: Dietary supplement: Fish Oil; Drug: Metformin; Combination product: Fish Oil and Metformin

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 Type: Interventional
• Enrollment (Estimated): 180
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 28 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Fish Oil; Fish oil capsules 1200mg 6 tablets/day 12 weeks	Dietary supplement: Fish Oil; 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
Other: Metformin; Metformin tablets (500 mg) 2/day 12 weeks	Drug: Metformin; Manufacturer's standard 500 mg. Submission Control No.:128147; Other Names: Metformin Hydrochloride Oral Antihyperglycemic Agent.
Other: Fish Oil and Metformin; Combo of other 2 arms	Combination product: Fish Oil and Metformin; Combo of 2 other arms

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma insulin and glucose	reported as mean +/- SEM	At baseline and postintervention at 12 weeks
Plasma hormones, testosterone, SHBG, Estrogen	reported as mean +/- SEM	At baseline and postintervention at 12 weeks

Collaborators and Investigators

• Sponsor: University of Alberta
• Collaborators: Canadian Institutes of Health Research (CIHR); Women and Children's Health Research Institute, Canada; Alberta Diabetes Institute
• Investigators: Principal Investigator: Donna F Vine, PhD, Associate Professor

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2016
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: May 5, 2018
• First Submitted That Met QC Criteria: October 2, 2019
• First Posted (Actual): October 4, 2019

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: diabetes; obesity; Polycystic Ovary Syndrome; metabolic and cardiovascular diseases
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Polycystic Ovary Syndrome; Syndrome; Metabolic Diseases; Lipid Metabolism Disorders; Physiological Effects of Drugs; Hypoglycemic Agents; Metformin
• Other Study ID Numbers: PRO00059201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There will be no sharing with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No