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

Aalborg University Hospital

Status: Completed

Conditions: Premenopause; Postmenopause

Treatments: Dietary Supplement: Thistle oil; Dietary Supplement: marine n-3 polyunsaturated fatty acids; Dietary Supplement: thistle oil

Study type: Interventional

Funder types: Other

Identifiers

NCT00901589

Petra Witt

Details and patient eligibility

About

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.

Enrollment: 92 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• hormone treatment
• foreseen compliance problem
• fish oil consumers

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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92 participants in 4 patient groups, including a placebo group

Premenopausal women-fishoil

Active Comparator group

Treatment:

Dietary Supplement: marine n-3 polyunsaturated fatty acids

Dietary Supplement: marine n-3 polyunsaturated fatty acids

Premenopausal-placebo

Placebo Comparator group

Treatment:

Dietary Supplement: thistle oil

Postmenopausal women-fishoil

Active Comparator group

Treatment:

Dietary Supplement: marine n-3 polyunsaturated fatty acids

Dietary Supplement: marine n-3 polyunsaturated fatty acids

Postmenopausal-placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Thistle oil