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

This study has been completed.
Sponsor:
Collaborator:
Royal Perth Hospital
Information provided by:
Keogh Institute for Medical Research
ClinicalTrials.gov Identifier:
NCT00620529
First received: February 11, 2008
Last updated: January 31, 2010
Last verified: January 2010

February 11, 2008
January 31, 2010
February 2008
December 2008   (final data collection date for primary outcome measure)
24 hour ambulatory systolic blood pressure [ Time Frame: week 8 and week 24 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00620529 on ClinicalTrials.gov Archive Site
  • 24 hour heart rate variability [ Time Frame: week 8 and week 24 ] [ Designated as safety issue: No ]
  • liver fat content (MRI) [ Time Frame: week 8 and week 24 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Effects of Fish Oils on Blood Pressure, Heart Rate Variability and Liver Fat in the Polycystic Ovary Syndrome
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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Polycystic Ovary Syndrome
  • Dietary Supplement: Ocean Nutrition 2050
    1000mg capsules, 4 capsules/day for 8 weeks
    Other Name: Code name: 2050
  • Dietary Supplement: Olive oil capsules
    Olive oil capsules, 4 per day for 8 weeks
  • Experimental: 1
    20/50 fish oil, 1000mg capsules, Ocean Nutrition 2050,4g/day.
    Intervention: Dietary Supplement: Ocean Nutrition 2050
  • Placebo Comparator: 2
    olive oil capsules
    Intervention: Dietary Supplement: Olive oil capsules
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
February 2009
December 2008   (final data collection date for primary outcome measure)

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).
Female
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00620529
EC 2008/049
Yes
Dr Andrea Cussons, University of Western Australia
Keogh Institute for Medical Research
Royal Perth Hospital
Principal Investigator: Andrea J Cussons, MBBS The University of Western Australia
Keogh Institute for Medical Research
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP