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

Study Overview
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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.

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

Conditions
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Postmenopause, Premenopause

Intervention / Treatment
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* Dietary Supplement: marine n-3 polyunsaturated fatty acids
* Dietary Supplement: thistle oil
* Dietary Supplement: marine n-3 polyunsaturated fatty acids
* Dietary Supplement: Thistle oil


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Premenopausal women-fishoil<br> | Dietary Supplement: marine n-3 polyunsaturated fatty acids<br>* Four capsules daily containing 2.2 g marine n-3 polyunsaturated fatty acids in total<br>* Other names: Fish oil;|
| Placebo Comparator: Premenopausal-placebo<br> | Dietary Supplement: thistle oil<br>* four capsules a day<br>|
| Active Comparator: Postmenopausal women-fishoil<br> | Dietary Supplement: marine n-3 polyunsaturated fatty acids<br>* Four capsules daily, 2.2 g marine n-3 PUFAs in total<br>* Other names: Fish oil;|
| Placebo Comparator: Postmenopausal-placebo<br> | Dietary Supplement: Thistle oil<br>* Four capsules daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of oestrogen concentrations in blood before and after intervention |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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