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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Polycystic Ovary Syndrome
 Dietary Supplement: Ocean Nutrition 2050
Dietary Supplement: Olive oil capsules
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Keogh Institute for Medical Research:

Primary Outcome Measures:
  • 24 hour ambulatory systolic blood pressure [ Time Frame: week 8 and week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: February 2008
Study Completion Date: February 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
20/50 fish oil, 1000mg capsules, Ocean Nutrition 2050,4g/day.
 Dietary Supplement: Ocean Nutrition 2050
1000mg capsules, 4 capsules/day for 8 weeks
Other Name: Code name: 2050
Placebo Comparator: 2
olive oil capsules
 Dietary Supplement: Olive oil capsules
Olive oil capsules, 4 per day for 8 weeks

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00620529

Locations
Australia, Western Australia
School of Medicine and Pharmacology, Royal Perth Hospital
Perth, Western Australia, Australia, 6000
Sponsors and Collaborators
Keogh Institute for Medical Research
Royal Perth Hospital
Investigators
Principal Investigator: Andrea J Cussons, MBBS The University of Western Australia
  More Information

No publications provided

Responsible Party: Dr Andrea Cussons, University of Western Australia
ClinicalTrials.gov Identifier: NCT00620529     History of Changes
Other Study ID Numbers: EC 2008/049
Study First Received: February 11, 2008
Last Updated: January 31, 2010
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Keogh Institute for Medical Research:
polycystic ovary syndrome
cardiovascular risk
metabolism
 blood pressure
liver fat
heart rate variability

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
 Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 23, 2013