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

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

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2009-02-28

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.

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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.

Conditions

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Polycystic Ovary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

20/50 fish oil, 1000mg capsules, Ocean Nutrition 2050,4g/day.

Group Type EXPERIMENTAL

Ocean Nutrition 2050

Intervention Type DIETARY_SUPPLEMENT

1000mg capsules, 4 capsules/day for 8 weeks

2

olive oil capsules

Group Type PLACEBO_COMPARATOR

Olive oil capsules

Intervention Type DIETARY_SUPPLEMENT

Olive oil capsules, 4 per day for 8 weeks

Interventions

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Ocean Nutrition 2050

1000mg capsules, 4 capsules/day for 8 weeks

Intervention Type DIETARY_SUPPLEMENT

Olive oil capsules

Olive oil capsules, 4 per day for 8 weeks

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Code name: 2050

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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No