Postmenopause Clinical Trial
Official title:
The Incorporation of Marine n-3 Polyunsaturated Fatty Acids in Pre- and Postmenopausal Women: a Randomized Double-Blinded Placebo-Controlled Clinical Trial
Verified date | May 2009 |
Source | Aalborg Universitetshospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Denmark: Danish Dataprotection Agency |
Study type | Interventional |
The study is a randomised placebo controlled double-blinded clinical trial where a group of healthy pre- and postmenopausal women is randomised to the intake of fish oil capsules or placebo oil capsules for 12 weeks. Anthropometric measurements(weight, height,blood pressure) blood samples and adipose tissue biopsies will be taken in order to illustrate the effect of marine n-3 PUFAs (fish oil) on the concentration of circulating female hormones and to investigate what impact menopause might have on the ability to incorporate marine n-3 PUFAs into tissues.
Status | Completed |
Enrollment | 92 |
Est. completion date | May 2009 |
Est. primary completion date | May 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - age 18-70 years old - healthy or well-treated chronic disease Exclusion Criteria: - hormone treatment - foreseen compliance problem - fish oil consumers |
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Denmark | Center for cardiovascular research, Aalborg Hospital | Aalborg |
Lead Sponsor | Collaborator |
---|---|
Aalborg Universitetshospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Content of marine n-PUFAs as percent of total content of fatty acids in adipose tissue and in platelets before and after intervention | No | ||
Secondary | Measurement of oestrogen concentrations in blood before and after intervention | No |
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