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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00620529

Acronym

fops

Enrollment

Registered

2008-02-21

Start date

2008-02-29

Completion date

2009-02-28

Last updated

2010-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovary Syndrome

Keywords

polycystic ovary syndrome, cardiovascular risk, metabolism, blood pressure, liver fat, heart rate variability

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.

Interventions

DIETARY_SUPPLEMENTOcean Nutrition 2050

1000mg capsules, 4 capsules/day for 8 weeks

DIETARY_SUPPLEMENTOlive oil capsules

Olive oil capsules, 4 per day for 8 weeks

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

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).

Design outcomes

Primary

Measure	Time frame
24 hour ambulatory systolic blood pressure	week 8 and week 24

Secondary

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

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026