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

May 13, 2009 updated by: Aalborg University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9000
        • Center for cardiovascular research, Aalborg Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • hormone treatment
  • foreseen compliance problem
  • fish oil consumers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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 Names:
  • Fish oil
Dietary supplement: marine n-3 polyunsaturated fatty acids
Four capsules daily, 2.2 g marine n-3 PUFAs in total
Other Names:
  • 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 containing 2.2 g marine n-3 polyunsaturated fatty acids in total
Other Names:
  • Fish oil
Dietary supplement: marine n-3 polyunsaturated fatty acids
Four capsules daily, 2.2 g marine n-3 PUFAs in total
Other Names:
  • Fish oil
PLACEBO_COMPARATOR: Postmenopausal-placebo
Dietary supplement: Thistle oil
Four capsules daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
Measurement of oestrogen concentrations in blood before and after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aalborg University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (ACTUAL)

May 1, 2009

Study Completion (ACTUAL)

May 1, 2009

Study Registration Dates

First Submitted

May 13, 2009

First Submitted That Met QC Criteria

May 13, 2009

First Posted (ESTIMATE)

May 14, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

May 14, 2009

Last Update Submitted That Met QC Criteria

May 13, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Petra Witt

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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