Dietary Fish Oil Intervention in Polycystic Ovary Syndrome (PCOS)

University of Alberta

Status and phase: Enrolling; Phase 1

Conditions: Lipid Metabolism Disorders; Polycystic Ovary Syndrome

Treatments: Drug: Metformin; Dietary Supplement: Fish Oil; Combination Product: Fish Oil and Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT04116203

PRO00059201

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 180 estimated patients

Sex: Female

Ages: 18 to 30 years old

Volunteers: No 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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 3 patient groups

Fish Oil

Other group

Description:

Fish oil capsules 1200mg 6 tablets/day 12 weeks

Treatment:

Dietary Supplement: Fish Oil

Metformin

Other group

Description:

Metformin tablets (500 mg) 2/day 12 weeks

Treatment:

Drug: Metformin

Fish Oil and Metformin

Other group

Description:

Combo of other 2 arms

Treatment:

Combination Product: Fish Oil and Metformin