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

Primary Purpose

Polycystic Ovary Syndrome, Lipid Metabolism Disorders

Status

Suspended

Phase

Phase 1

Locations

Canada

Study Type

Interventional

Intervention

Metformin

Fish Oil and Metformin

Fish Oil

About this trial

This is an interventional health services research trial for Polycystic Ovary Syndrome focused on measuring Polycystic Ovary Syndrome, metabolic and cardiovascular diseases, diabetes, obesity

Eligibility Criteria

18 Years - 30 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

9-111 Endocrinology Department, UofA Hospital
2-004 Li Ka Shing Centre, UofA

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Arm Label

Fish Oil

Metformin

Fish Oil and Metformin

Arm Description

Fish oil capsules 1200mg 6 tablets/day 12 weeks

Metformin tablets (500 mg) 2/day 12 weeks

Combo of other 2 arms

Outcomes

Primary Outcome Measures

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

reported as mean +/- SEM

Secondary Outcome Measures

Plasma insulin and glucose

reported as mean +/- SEM

Plasma hormones, testosterone, SHBG, Estrogen

reported as mean +/- SEM

Full Information

NCT ID

NCT04116203

First Posted

May 5, 2018

Last Updated

May 30, 2023

Sponsor

University of Alberta

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04116203

Brief Title

Dietary Fish Oil Intervention in Polycystic Ovary Syndrome (PCOS)

Acronym

PCOS

Official Title

Dietary Fish Oil Intervention in Polycystic Ovary Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Suspended

Why Stopped

waiting for additional funding to complete trial

Study Start Date

June 30, 2016 (Actual)

Primary Completion Date

December 30, 2023 (Anticipated)

Study Completion Date

December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Alberta

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Polycystic Ovary Syndrome, Lipid Metabolism Disorders

Keywords

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

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

None (Open Label)

Masking Description

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

Allocation

Randomized

Enrollment

180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Fish Oil

Arm Type

Other

Arm Description

Fish oil capsules 1200mg 6 tablets/day 12 weeks

Arm Title

Metformin

Arm Type

Other

Arm Description

Metformin tablets (500 mg) 2/day 12 weeks

Arm Title

Fish Oil and Metformin

Arm Type

Other

Arm Description

Combo of other 2 arms

Intervention Type

Drug

Intervention Name(s)

Metformin

Other Intervention Name(s)

Metformin Hydrochloride Oral Antihyperglycemic Agent.

Intervention Description

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

Intervention Type

Combination Product

Intervention Name(s)

Fish Oil and Metformin

Intervention Description

Combo of 2 other arms

Intervention Type

Dietary Supplement

Intervention Name(s)

Fish Oil

Other Intervention Name(s)

Fish Oil; Fish Oil 1200 Mg; Omega-3

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

reported as mean +/- SEM

Time Frame

At baseline and postintervention at 12 weeks

Secondary Outcome Measure Information:

Title

Plasma insulin and glucose

Description

reported as mean +/- SEM

Time Frame

At baseline and postintervention at 12 weeks

Title

Plasma hormones, testosterone, SHBG, Estrogen

Description

reported as mean +/- SEM

Time Frame

At baseline and postintervention at 12 weeks

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

The focus of this study is on overweight-obese high-risk metabolically-resistant young women (aged 18-30 yrs) newly diagnosed with PCOS

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Donna F Vine, PhD

Organizational Affiliation

Associate Professor

Official's Role

Principal Investigator

Facility Information:

Facility Name

9-111 Endocrinology Department, UofA Hospital

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2B7

Country

Canada

Facility Name

2-004 Li Ka Shing Centre, UofA

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2E1

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

There will be no sharing with other researchers.

Citations:

PubMed Identifier

27997268

Citation

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.

Results Reference

result

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Dietary Fish Oil Intervention in Polycystic Ovary Syndrome (PCOS)

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