Dietary Fish Oil Intervention in Polycystic Ovary Syndrome (PCOS)

NCT04116203 | Completed Phase 1 DMC

• 1 other identifier: PRO00059201
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

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.

Conditions

Polycystic Ovary Syndrome; Lipid Metabolism Disorders

Keywords

Polycystic Ovary Syndrome; metabolic and cardiovascular diseases; diabetes; obesity

Outcome Measures

Primary Outcomes (1)

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

  reported as mean +/- SEM

  At baseline and postintervention at 12 weeks

Secondary Outcomes (2)

• Plasma insulin and glucose

  At baseline and postintervention at 12 weeks

• Plasma hormones, testosterone, SHBG, Estrogen

  At baseline and postintervention at 12 weeks

Study Arms (3)

Fish Oil

OTHER

Fish oil capsules 1200mg 6 tablets/day 12 weeks

Dietary Supplement: Fish Oil

Metformin

OTHER

Metformin tablets (500 mg) 2/day 12 weeks

Drug: Metformin

Fish Oil and Metformin

OTHER

Combo of other 2 arms

Combination Product: Fish Oil and Metformin

Interventions

Metformin DRUG

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

Also known as: Metformin Hydrochloride Oral Antihyperglycemic Agent.

Metformin

Fish Oil and Metformin COMBINATION_PRODUCT

Combo of 2 other arms

Fish Oil and Metformin

Fish Oil DIETARY_SUPPLEMENT

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

Fish Oil

Eligibility Criteria

• Age: 18 Years - 30 Years
• Gender Eligibility Details: The focus of this study is on overweight-obese high-risk metabolically-resistant young women (aged 18-30 yrs) newly diagnosed with PCOS
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female
• Age at time of enrollment \> 18 to \<30 years
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (2)

9-111 Endocrinology Department, UofA Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

2-004 Li Ka Shing Centre, UofA

Edmonton, Alberta, T6G 2E1, Canada

Location

Related Publications (1)

• 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.

  PMID: 27997268 RESULT

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Lipid Metabolism Disorders; Cardiovascular Diseases; Diabetes Mellitus; Obesity

Interventions

Metformin; Fish Oils; Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Glucose Metabolism Disorders; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Oils; Lipids; Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Fatty Acids, Unsaturated; Fatty Acids

Study Officials

• Donna F Vine, PhD

  Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is a randomized open-label parallel study in overweight/obese young women with PCOS, in which the participant will be randomly assigned to one of three treatment arms
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Outcomes at 6 and 12 weeks will be compared to baseline values to determine the efficacy of interventions. Participants will act as their own control in each intervention

Study Record Dates

• First Submitted: May 5, 2018
• First Posted: October 4, 2019
• Study Start: June 30, 2016
• Primary Completion: November 12, 2020
• Study Completion: November 12, 2020
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)