Dietary Fish Oil Intervention in Polycystic Ovary Syndrome (PCOS)

Study Overview
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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.

Detailed Description
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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.

Official Title
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Dietary Fish Oil Intervention in Polycystic Ovary Syndrome

Conditions
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Polycystic Ovary Syndrome, Lipid Metabolism Disorders

Intervention / Treatment
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* Drug: Metformin
* Combination Product: Fish Oil and Metformin
* Dietary Supplement: Fish Oil


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Fish Oil<br>Fish oil capsules 1200mg 6 tablets/day 12 weeks | Dietary Supplement: Fish Oil<br>* NPN: 80028808 Licence Holder: WN Pharmaceuticals Ltd Dosage Form: Capsule, soft Recommended Route of Administration: Oral<br>* Other names: Fish Oil; Fish Oil 1200 Mg; Omega-3;|
| Other: Metformin<br>Metformin tablets (500 mg) 2/day 12 weeks | Drug: Metformin<br>* Manufacturer's standard 500 mg. Submission Control No.:128147<br>* Other names: Metformin Hydrochloride Oral Antihyperglycemic Agent.;|
| Other: Fish Oil and Metformin<br>Combo of other 2 arms | Combination Product: Fish Oil and Metformin<br>* Combo of 2 other arms<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 Outcome Measures

| Outcome Measure | 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 | At baseline and postintervention at 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, Polycystic Ovary Syndrome, metabolic and cardiovascular diseases, diabetes