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

NCT ID: NCT00901589

Last Updated: 2009-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2009-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Postmenopause Premenopause

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Premenopausal women-fishoil

Group Type ACTIVE_COMPARATOR

marine n-3 polyunsaturated fatty acids

Intervention Type DIETARY_SUPPLEMENT

Four capsules daily containing 2.2 g marine n-3 polyunsaturated fatty acids in total

Premenopausal-placebo

Group Type PLACEBO_COMPARATOR

thistle oil

Intervention Type DIETARY_SUPPLEMENT

four capsules a day

Postmenopausal women-fishoil

Group Type ACTIVE_COMPARATOR

marine n-3 polyunsaturated fatty acids

Intervention Type DIETARY_SUPPLEMENT

Four capsules daily, 2.2 g marine n-3 PUFAs in total

Postmenopausal-placebo

Group Type PLACEBO_COMPARATOR

Thistle oil

Intervention Type DIETARY_SUPPLEMENT

Four capsules daily

Interventions

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marine n-3 polyunsaturated fatty acids

Four capsules daily containing 2.2 g marine n-3 polyunsaturated fatty acids in total

Intervention Type DIETARY_SUPPLEMENT

thistle oil

four capsules a day

Intervention Type DIETARY_SUPPLEMENT

marine n-3 polyunsaturated fatty acids

Four capsules daily, 2.2 g marine n-3 PUFAs in total

Intervention Type DIETARY_SUPPLEMENT

Thistle oil

Four capsules daily

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Fish oil Fish oil

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* hormone treatment
* foreseen compliance problem
* fish oil consumers
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Aalborg University Hospital

OTHER

Sponsor Role lead

Locations

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Center for cardiovascular research, Aalborg Hospital

Aalborg, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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Petra Witt

Identifier Type: -

Identifier Source: org_study_id

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