The Effects of Fish Oils on Blood Pressure, Heart Rate Variability and Liver Fat in the Polycystic Ovary Syndrome

Study Overview
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Brief Summary
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We hypothesise that fish oils will have a beneficial effect on cardiometabolic parameters in women with PCOS. The purpose of this study therefore is to examine the effects of fish oils on blood pressure, heart rate variability and liver fat content in obese women with the polycystic ovary syndrome.

Detailed Description
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The prevalence of abnormalities of blood pressure (ABP), variability of heart rate (HRV) and liver fat content is increased in women with the polycystic ovary syndrome (PCOS). We hypothesise that fish oils will have a beneficial effect on these endpoints and other cardiometabolic parameters such as cholesterol and liver function in women with PCOS. This crossover study of 40 obese women with PCOS will therefore examine the effects of fish oils on the above parameters compared with placebo (olive oil). Subjects with PCOS who have participated in previous studies with this research group will be approached for recruitment, as will eligible subjects within the endocrine clinics of the chief and co-investigators.

Official Title
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A Clinical Trial to Measure the Effect of DHA-enriched Fish Oils on Blood Pressure, Heart Rate Variability and Liver Fat Content in the Polycystic Ovary Syndrome

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Dietary Supplement: Ocean Nutrition 2050
* Dietary Supplement: Olive oil capsules


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Overweight/obese women with PCOS as per 1990 NIH criteria (see below) Non-smokers Age>18 years, premenopausal Acceptable to have/be on treatment for type 2 diabetes mellitus and/or dyslipidaemia Acceptable to be taking the oral contraceptive pill Exclusion Criteria: Uncontrolled hypertension (BP>160/100mmHg) Known co-morbidities including liver or renal disease Already taking fish oil supplements Other intercurrent illness (major surgery, CV event) Smokers Alcohol intake >20g/day Pregnancy Any metallic implant (contraindication for MRI).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>20/50 fish oil, 1000mg capsules, Ocean Nutrition 2050,4g/day. | Dietary Supplement: Ocean Nutrition 2050<br>* 1000mg capsules, 4 capsules/day for 8 weeks<br>* Other names: Code name: 2050;|
| Placebo Comparator: 2<br>olive oil capsules | Dietary Supplement: Olive oil capsules<br>* Olive oil capsules, 4 per day for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 hour ambulatory systolic blood pressure |  | week 8 and week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 hour heart rate variability |  | week 8 and week 24 | 
| liver fat content (MRI) |  | week 8 and week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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polycystic ovary syndrome, cardiovascular risk, metabolism, blood pressure, liver fat, heart rate variability