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

NCT00620529 | Completed Phase 4 DMC

• 1 other identifier: EC 2008/049
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 24 hour ambulatory systolic blood pressure

  week 8 and week 24

Secondary Outcomes (2)

• 24 hour heart rate variability

  week 8 and week 24

• liver fat content (MRI)

  week 8 and week 24

Study Arms (2)

1

EXPERIMENTAL

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

Dietary Supplement: Ocean Nutrition 2050

2

PLACEBO COMPARATOR

olive oil capsules

Dietary Supplement: Olive oil capsules

Interventions

Ocean Nutrition 2050 DIETARY_SUPPLEMENT

1000mg capsules, 4 capsules/day for 8 weeks

Also known as: Code name: 2050

1

Olive oil capsules DIETARY_SUPPLEMENT

Olive oil capsules, 4 per day for 8 weeks

2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Keogh Institute for Medical Research: lead
• Royal Perth Hospital: collaborator

Study Sites (1)

School of Medicine and Pharmacology, Royal Perth Hospital

Perth, Western Australia, 6000, Australia

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Fatty Liver

Interventions

Olive Oil

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Andrea J Cussons, MBBS

  The University of Western Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 11, 2008
• First Posted: February 21, 2008
• Study Start: February 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: February 1, 2009
• Last Updated: February 2, 2010

Record last verified: 2010-01

Locations

AU (1)