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

This study has been completed.
Sponsor:
Information provided by:
Aalborg Universityhospital
ClinicalTrials.gov Identifier:
NCT00901589
First received: May 13, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  Purpose

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 Intervention
Postmenopause
Premenopause
Dietary Supplement: marine n-3 polyunsaturated fatty acids
Dietary Supplement: thistle oil
Dietary Supplement: Thistle oil

Study Type: Interventional
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
Official Title: The Incorporation of Marine n-3 Polyunsaturated Fatty Acids in Pre- and Postmenopausal Women: a Randomized Double-Blinded Placebo-Controlled Clinical Trial

Resource links provided by NLM:


Further study details as provided by Aalborg Universityhospital:

Primary Outcome Measures:
  • Content of marine n-PUFAs as percent of total content of fatty acids in adipose tissue and in platelets before and after intervention [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measurement of oestrogen concentrations in blood before and after intervention [ Designated as safety issue: No ]

Enrollment: 92
Study Start Date: August 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00901589

Locations
Denmark
Center for cardiovascular research, Aalborg Hospital
Aalborg, Denmark, 9000
Sponsors and Collaborators
Aalborg Universityhospital
  More Information

No publications provided

Responsible Party: Dr., ph.d.stud. Petra Witt
ClinicalTrials.gov Identifier: NCT00901589     History of Changes
Other Study ID Numbers: Petra Witt
Study First Received: May 13, 2009
Last Updated: May 13, 2009
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Aalborg Universityhospital:
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

ClinicalTrials.gov processed this record on September 18, 2014