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Marine n-3 Polyunsaturated Fatty Acids in Pre- and Postmenopausal Women

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ClinicalTrials.gov Identifier: NCT00901589
Recruitment Status : Completed
First Posted : May 14, 2009
Last Update Posted : May 14, 2009
Sponsor:
Information provided by:
Aalborg Universitetshospital

Brief 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.

Condition or disease Intervention/treatment Phase
Postmenopause Premenopause Dietary Supplement: marine n-3 polyunsaturated fatty acids Dietary Supplement: thistle oil Dietary Supplement: Thistle oil Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Incorporation of Marine n-3 Polyunsaturated Fatty Acids in Pre- and Postmenopausal Women: a Randomized Double-Blinded Placebo-Controlled Clinical Trial
Study Start Date : August 2007
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Premenopausal women-fishoil Dietary Supplement: marine n-3 polyunsaturated fatty acids
Four capsules daily containing 2.2 g marine n-3 polyunsaturated fatty acids in total
Other Name: Fish oil
Placebo Comparator: Premenopausal-placebo Dietary Supplement: thistle oil
four capsules a day
Active Comparator: Postmenopausal women-fishoil Dietary Supplement: marine n-3 polyunsaturated fatty acids
Four capsules daily, 2.2 g marine n-3 PUFAs in total
Other Name: Fish oil
Placebo Comparator: Postmenopausal-placebo Dietary Supplement: Thistle oil
Four capsules daily



Primary Outcome Measures :
  1. Content of marine n-PUFAs as percent of total content of fatty acids in adipose tissue and in platelets before and after intervention

Secondary Outcome Measures :
  1. Measurement of oestrogen concentrations in blood before and after intervention


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age 18-70 years old
  • healthy or well-treated chronic disease

Exclusion Criteria:

  • hormone treatment
  • foreseen compliance problem
  • fish oil consumers

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00901589


Locations
Denmark
Center for cardiovascular research, Aalborg Hospital
Aalborg, Denmark, 9000
Sponsors and Collaborators
Aalborg Universitetshospital

Responsible Party: Dr., ph.d.stud. Petra Witt
ClinicalTrials.gov Identifier: NCT00901589     History of Changes
Other Study ID Numbers: Petra Witt
First Posted: May 14, 2009    Key Record Dates
Last Update Posted: May 14, 2009
Last Verified: May 2009

Keywords provided by Aalborg Universitetshospital:
n-3 PUFAs
menopause
adipose tissue
estrogens
Incorporation of fishoil in pre- and postmenopausal women
Marine n-3 PUFAs influence on female hormones in blood