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

Phase 4

Completed

• Conditions: Polycystic Ovary Syndrome
• Interventions: Dietary Supplement: Ocean Nutrition 2050; Dietary Supplement: Olive oil capsules

• Registration Number: NCT00620529
• Lead Sponsor: Keogh Institute for Medical Research

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-11
• Study First Submitted QC: 2008-02-20
• Study First Posted: 2008-02-21
• Primary Completion: 2008-12
• Study Completion: 2009-02
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-31
• Last Update Posted: 2010-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Ocean Nutrition 2050	20/50 fish oil, 1000mg capsules, Ocean Nutrition 2050,4g/day.
2	Olive oil capsules	olive oil capsules

Primary Outcome Measures

Name	Time	Method
24 hour ambulatory systolic blood pressure	week 8 and week 24

Secondary Outcome Measures

Name	Time	Method
24 hour heart rate variability	week 8 and week 24
liver fat content (MRI)	week 8 and week 24

Trial Locations

Locations (1)

School of Medicine and Pharmacology, Royal Perth Hospital; 🇦🇺 Perth, Western Australia, Australia