Dietary Fish Oil Intervention in Polycystic Ovary Syndrom... | NCT04116203

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

NCT04116203

Sponsor

University of Alberta

Status

Completed

Last Update Posted

Feb 28, 2025Actual

Enrollment

52Actual

Phase

Phase 1

Conditions

Polycystic Ovary Syndrome
Lipid Metabolism Disorders

Interventions

Metformin
Fish Oil and Metformin
Fish Oil

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 30, 2016Actual

Primary Completion Date

Nov 12, 2020Actual

Completion Date

Nov 12, 2020Actual

First Submitted Date

May 5, 2018

First Submission Date that Met QC Criteria

Oct 2, 2019

First Posted Date

Oct 4, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 27, 2025

Last Update Posted Date

Feb 28, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

University of AlbertaOTHER

Collaborators

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

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

52Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Metformin	Drug	Manufacturer's standard 500 mg. Submission Control No.:128147	Metformin

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender 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

18 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Donna F Vine, PhD	Associate Professor	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
9-111 Endocrinology Department, UofA Hospital		Edmonton	Alberta	T6G 2B7	Canada
2-004 Li Ka Shing Centre, UofA

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27997268	Result	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.

ID	Term
D011085	Polycystic Ovary Syndrome
D052439	Lipid Metabolism Disorders
D002318	Cardiovascular Diseases
D003920	Diabetes Mellitus
D009765	Obesity

ID	Term
D010048	Ovarian Cysts
D003560	Cysts
D009369	Neoplasms
D010049	Ovarian Diseases
D000291

ID	Term
D008687	Metformin
D005395	Fish Oils
D004281	Docosahexaenoic Acids

ID	Term
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals
D009821