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

January 31, 2010 updated by: Keogh Institute for Medical Research

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Western Australia
      • Perth, Western Australia, Australia, 6000
        • School of Medicine and Pharmacology, Royal Perth Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Code name: 2050
PLACEBO_COMPARATOR: 2
olive oil capsules
Dietary supplement: Olive oil capsules
Olive oil capsules, 4 per day for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
24 hour ambulatory systolic blood pressure
Time Frame: week 8 and week 24
week 8 and week 24

Secondary Outcome Measures

Outcome Measure
Time Frame
24 hour heart rate variability
Time Frame: week 8 and week 24
week 8 and week 24
liver fat content (MRI)
Time Frame: week 8 and week 24
week 8 and week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Keogh Institute for Medical Research

Collaborators

Royal Perth Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (ACTUAL)

December 1, 2008

Study Completion (ACTUAL)

February 1, 2009

Study Registration Dates

First Submitted

February 11, 2008

First Submitted That Met QC Criteria

February 20, 2008

First Posted (ESTIMATE)

February 21, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

February 2, 2010

Last Update Submitted That Met QC Criteria

January 31, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC 2008/049

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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