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

Postmenopause Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00901589
• Other study ID #: Petra Witt
• Status: Completed
• Phase: N/A
• First received: May 13, 2009
• Last updated: May 13, 2009
• Start date: August 2007
• Est. completion date: May 2009

Study information

• Verified date: May 2009
• Source: Aalborg Universitetshospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• age 18-70 years old

• healthy or well-treated chronic disease

Exclusion Criteria:

• hormone treatment

• foreseen compliance problem

• fish oil consumers

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

Related Conditions & MeSH terms

• Postmenopause
• Premenopause

Intervention

Dietary Supplement:
• marine n-3 polyunsaturated fatty acids
Four capsules daily containing 2.2 g marine n-3 polyunsaturated fatty acids in total
• thistle oil
four capsules a day
• marine n-3 polyunsaturated fatty acids
Four capsules daily, 2.2 g marine n-3 PUFAs in total
• Thistle oil
Four capsules daily

Locations

Country	Name	City	State
Denmark	Center for cardiovascular research, Aalborg Hospital	Aalborg

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg Universitetshospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Content of marine n-PUFAs as percent of total content of fatty acids in adipose tissue and in platelets before and after intervention			No
Secondary	Measurement of oestrogen concentrations in blood before and after intervention			No