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Sponsors and Collaborators: |
Keogh Institute for Medical Research Royal Perth Hospital |
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Information provided by: | Keogh Institute for Medical Research |
ClinicalTrials.gov Identifier: | NCT00620529 |
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 |
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Polycystic Ovary Syndrome |
Dietary Supplement: Ocean Nutrition 2050 Dietary Supplement: Olive oil capsules |
Phase IV |
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 |
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 |
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1: Experimental
20/50 fish oil, 1000mg capsules, Ocean Nutrition 2050,4g/day.
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Dietary Supplement: Ocean Nutrition 2050
1000mg capsules, 4 capsules/day for 8 weeks
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2: Placebo Comparator
olive oil capsules
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Dietary Supplement: Olive oil capsules
Olive oil capsules, 4 per day for 8 weeks
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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.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Australia, Western Australia | |
School of Medicine and Pharmacology, Royal Perth Hospital | |
Perth, Western Australia, Australia, 6000 |
Principal Investigator: | Andrea J Cussons, MBBS | University of Western Australia |
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 History of Changes |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
polycystic ovary syndrome cardiovascular risk metabolism |
blood pressure liver fat heart rate variability |
Genital Diseases, Female Gonadal Disorders Polycystic Ovary Syndrome Endocrine System Diseases Endocrinopathy |
Ovarian Diseases Cysts Ovarian Cysts Polycystic Ovarian Syndrome |
Genital Diseases, Female Neoplasms Pathologic Processes Disease Gonadal Disorders Syndrome |
Polycystic Ovary Syndrome Endocrine System Diseases Ovarian Diseases Cysts Ovarian Cysts Adnexal Diseases |