Dietary Fish Oil Intervention in Polycystic Ovary Syndrome (PCOS)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2020-11-12

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Polycystic Ovary Syndrome Lipid Metabolism Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

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

Study Groups

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Fish Oil

Fish oil capsules 1200mg 6 tablets/day 12 weeks

Group Type OTHER

Fish Oil

Intervention Type DIETARY_SUPPLEMENT

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

Metformin

Metformin tablets (500 mg) 2/day 12 weeks

Group Type OTHER

Metformin

Intervention Type DRUG

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

Fish Oil and Metformin

Combo of other 2 arms

Group Type OTHER

Fish Oil and Metformin

Intervention Type COMBINATION_PRODUCT

Combo of 2 other arms

Interventions

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Metformin

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

Intervention Type DRUG

Fish Oil and Metformin

Combo of 2 other arms

Intervention Type COMBINATION_PRODUCT

Fish Oil

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Metformin Hydrochloride Oral Antihyperglycemic Agent. Fish Oil; Fish Oil 1200 Mg; Omega-3

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No