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

Official Title: “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”

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.

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.

Intervention(s) in this Clinical Trial

• Dietary Supplement: Ocean Nutrition 2050
  • 1000mg capsules, 4 capsules/day for 8 weeks
• Dietary Supplement: Olive oil capsules
  • Olive oil capsules, 4 per day for 8 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • 20/50 fish oil, 1000mg capsules, Ocean Nutrition 2050,4g/day.
• Placebo Comparator: 2
  • olive oil capsules

Primary Measures

• 24 hour ambulatory systolic blood pressure
  • Time Frame: week 8 and week 24
    Safety Issue?: No

Secondary Measures

• 24 hour heart rate variability
  • Time Frame: week 8 and week 24
    Safety Issue?: No
• liver fat content (MRI)
  • Time Frame: week 8 and week 24
    Safety Issue?: No

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).

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 50 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Keogh Institute for Medical Research Other

Overall Clinical Trial Officials and Contacts

Andrea J Cussons, MBBS Principal Investigator The University of Western Australia  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00620529

Study ID Number: EC 2008/049

ClinicalTrials.gov Identifier: NCT00620529

Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration