NCT00901589

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

May 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 14, 2009

Completed
Last Updated

May 14, 2009

Status Verified

May 1, 2009

Enrollment Period

1.8 years

First QC Date

May 13, 2009

Last Update Submit

May 13, 2009

Conditions

PostmenopausePremenopause

Keywords

n-3 PUFAsmenopauseadipose tissueestrogensIncorporation of fishoil in pre- and postmenopausal womenMarine n-3 PUFAs influence on female hormones in blood

Outcome Measures

Primary Outcomes (1)

  • Content of marine n-PUFAs as percent of total content of fatty acids in adipose tissue and in platelets before and after intervention

Secondary Outcomes (1)

  • Measurement of oestrogen concentrations in blood before and after intervention

Study Arms (4)

Premenopausal women-fishoil

ACTIVE COMPARATOR
Dietary Supplement: marine n-3 polyunsaturated fatty acids

Premenopausal-placebo

PLACEBO COMPARATOR
Dietary Supplement: thistle oil

Postmenopausal women-fishoil

ACTIVE COMPARATOR
Dietary Supplement: marine n-3 polyunsaturated fatty acids

Postmenopausal-placebo

PLACEBO COMPARATOR
Dietary Supplement: Thistle oil

Interventions

marine n-3 polyunsaturated fatty acidsDIETARY_SUPPLEMENT

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

Also known as: Fish oil
Premenopausal women-fishoil
Thistle oilDIETARY_SUPPLEMENT

four capsules a day

Premenopausal-placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • hormone treatment
  • foreseen compliance problem
  • fish oil consumers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for cardiovascular research, Aalborg Hospital

Aalborg, 9000, Denmark

Location

MeSH Terms

Interventions

Fish Oils

Intervention Hierarchy (Ancestors)

OilsLipids

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 13, 2009

First Posted

May 14, 2009

Study Start

August 1, 2007

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

May 14, 2009

Record last verified: 2009-05

Locations

DK(1)