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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00901589
Other study ID # Petra Witt
Secondary ID
Status Completed
Phase N/A
First received May 13, 2009
Last updated May 13, 2009
Start date August 2007
Est. completion date May 2009

Study information

Verified date May 2009
Source Aalborg Universitetshospital
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Dataprotection Agency
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
marine n-3 polyunsaturated fatty acids
Four capsules daily containing 2.2 g marine n-3 polyunsaturated fatty acids in total
thistle oil
four capsules a day
marine n-3 polyunsaturated fatty acids
Four capsules daily, 2.2 g marine n-3 PUFAs in total
Thistle oil
Four capsules daily

Locations

Country Name City State
Denmark Center for cardiovascular research, Aalborg Hospital Aalborg

Sponsors (1)

Lead Sponsor Collaborator
Aalborg Universitetshospital

Country where clinical trial is conducted

Denmark, 

Outcome

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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