Trial | NCT04116203  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Suspended

  • Study Participants

    180
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.
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.
Study Started
Jun 30
2016
Primary Completion
Dec 30
2023
Anticipated
Study Completion
Dec 30
2023
Anticipated
Last Update
Jun 01
2023

Drug Metformin

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

  • Other names: Metformin Hydrochloride Oral Antihyperglycemic Agent.

Combination Product Fish Oil and Metformin [fish oil (Omegavan), metformin (glucophage)]

Combo of 2 other arms

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

Fish Oil Other

Fish oil capsules 1200mg 6 tablets/day 12 weeks

Metformin Other

Metformin tablets (500 mg) 2/day 12 weeks

Fish Oil and Metformin Other

Combo of other 2 arms

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.
No Results Posted