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

Polycystic Ovary Syndrome Clinical Trial

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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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00620529
• Other study ID #: EC 2008/049
• Status: Completed
• Phase: Phase 4
• First received: February 11, 2008
• Last updated: January 31, 2010
• Start date: February 2008
• Est. completion date: February 2009

Study information

• Verified date: January 2010
• Source: Keogh Institute for Medical Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Dietary Supplement:
• Ocean Nutrition 2050
1000mg capsules, 4 capsules/day for 8 weeks
• Olive oil capsules
Olive oil capsules, 4 per day for 8 weeks

Locations

Country	Name	City	State
Australia	School of Medicine and Pharmacology, Royal Perth Hospital	Perth	Western Australia

Sponsors (2)

Lead Sponsor	Collaborator
Keogh Institute for Medical Research	Royal Perth Hospital

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24 hour ambulatory systolic blood pressure		week 8 and week 24	No
Secondary	24 hour heart rate variability		week 8 and week 24	No
Secondary	liver fat content (MRI)		week 8 and week 24	No