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Trial record 17 of 107 for:    Polycystic Ovary Syndrome: Clinical Trials

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:
ClinicalTrials.gov Identifier:
NCT00620529
First Posted: February 21, 2008
Last Update Posted: February 2, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Royal Perth Hospital
Information provided by:
Keogh Institute for Medical Research
  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
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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:


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 ]

Secondary Outcome Measures:
  • 24 hour heart rate variability [ Time Frame: week 8 and week 24 ]
  • liver fat content (MRI) [ Time Frame: week 8 and week 24 ]

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

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dr Andrea Cussons, University of Western Australia
ClinicalTrials.gov Identifier: NCT00620529     History of Changes
Other Study ID Numbers: EC 2008/049
First Submitted: February 11, 2008
First Posted: February 21, 2008
Last Update Posted: February 2, 2010
Last Verified: January 2010

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:
Syndrome
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases