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

Sponsors and Collaborators:	Keogh Institute for Medical Research Royal Perth Hospital
Information provided by:	Keogh Institute for Medical Research
ClinicalTrials.gov Identifier:	NCT00620529

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 IV

MedlinePlus related topics: Dietary Supplements

Drug Information available for: Fish oil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
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

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
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 20/50 fish oil, 1000mg capsules, Ocean Nutrition 2050,4g/day.	Dietary Supplement: Ocean Nutrition 2050 1000mg capsules, 4 capsules/day for 8 weeks
2: Placebo Comparator 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

University of Western Australia

More Information

Responsible Party:	University of Western Australia ( Dr Andrea Cussons )
Study ID Numbers:	EC 2008/049
Study First Received:	February 11, 2008
Last Updated:	June 12, 2008
ClinicalTrials.gov Identifier:	NCT00620529
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

Study placed in the following topic categories:

Genital Diseases, Female
Gonadal Disorders
Polycystic Ovary Syndrome
Endocrine System Diseases

Endocrinopathy
Ovarian Diseases
Cysts
Ovarian Cysts

Additional relevant MeSH terms:

Neoplasms
Pathologic Processes
Disease
Syndrome
Adnexal Diseases

ClinicalTrials.gov processed this record on January 16, 2009