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

Primary Purpose

Polycystic Ovary Syndrome

Status
Completed
Phase
Phase 4
Locations
Australia
Study Type
Interventional
Intervention
Ocean Nutrition 2050
Olive oil capsules
Sponsored by
Keogh Institute for Medical Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring polycystic ovary syndrome, cardiovascular risk, metabolism, blood pressure, liver fat, heart rate variability

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

  • School of Medicine and Pharmacology, Royal Perth Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

20/50 fish oil, 1000mg capsules, Ocean Nutrition 2050,4g/day.

olive oil capsules

Outcomes

Primary Outcome Measures

24 hour ambulatory systolic blood pressure

Secondary Outcome Measures

24 hour heart rate variability
liver fat content (MRI)

Full Information

First Posted
February 11, 2008
Last Updated
January 31, 2010
Sponsor
Keogh Institute for Medical Research
Collaborators
Royal Perth Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00620529
Brief Title
The Effects of Fish Oils on Blood Pressure, Heart Rate Variability and Liver Fat in the Polycystic Ovary Syndrome
Acronym
fops
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Keogh Institute for Medical Research
Collaborators
Royal Perth Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
polycystic ovary syndrome, cardiovascular risk, metabolism, blood pressure, liver fat, heart rate variability

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
20/50 fish oil, 1000mg capsules, Ocean Nutrition 2050,4g/day.
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
olive oil capsules
Intervention Type
Dietary Supplement
Intervention Name(s)
Ocean Nutrition 2050
Other Intervention Name(s)
Code name: 2050
Intervention Description
1000mg capsules, 4 capsules/day for 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Olive oil capsules
Intervention Description
Olive oil capsules, 4 per day for 8 weeks
Primary Outcome Measure Information:
Title
24 hour ambulatory systolic blood pressure
Time Frame
week 8 and week 24
Secondary Outcome Measure Information:
Title
24 hour heart rate variability
Time Frame
week 8 and week 24
Title
liver fat content (MRI)
Time Frame
week 8 and week 24

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea J Cussons, MBBS
Organizational Affiliation
The University of Western Australia
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Medicine and Pharmacology, Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia

12. IPD Sharing Statement

Learn more about this trial

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

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