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NCT Number: NCT00620529

The Effects of Fish Oils on Blood Pressure, Heart Rate Variability and Liver Fat 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.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Digestive System Diseases Endocrine System Diseases Fatty Liver Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Liver Diseases Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

School of Medicine and Pharmacology, Royal Perth Hospital

Perth, Western Australia, 6000, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Ocean Nutrition 2050

Dietary Supplement

1000mg capsules, 4 capsules/day for 8 weeks

Other names: Code name: 2050

olive oil capsules

Dietary Supplement

Olive oil capsules, 4 per day for 8 weeks

Primary outcomes

  1. 24 hour ambulatory systolic blood pressure

    Time frame: week 8 and week 24

Secondary outcomes

  1. 24 hour heart rate variability

    Time frame: week 8 and week 24

  2. liver fat content (MRI)

    Time frame: week 8 and week 24

Sponsors and collaborators

Lead sponsor

Keogh Institute for Medical Research

Other

Collaborators

  • Royal Perth Hospital

Registry information

Official study 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

Acronym: fops

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Feb 21, 2008
Registry last updated
Feb 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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