NCT01343576

Brief Summary

The aim of the study is to investigate if cow feeding regimes affects concentration of plasma phytanic acid and risk markers of the metabolic syndrome in human.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2009

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, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 28, 2011

Completed
Last Updated

April 28, 2011

Status Verified

November 1, 2009

Enrollment Period

3 months

First QC Date

April 18, 2011

Last Update Submit

April 26, 2011

Conditions

Coronary Heart Disease

Outcome Measures

Primary Outcomes (1)

  • plasma phytanic acid

    before and after the intervention (4 weeks)

Secondary Outcomes (8)

  • total cholesterol

    before and after the intervention (4 weeks)

  • LDL cholesterol

    before and after the intervention (4 weeks)

  • HDL cholesterol

    before and after the intervention (4 weeks)

  • triacylglycerol

    before and after the intervention (4 weeks)

  • C-reactive protein

    before and after the intervention (4 weeks)

  • +3 more secondary outcomes

Interventions

milk fatDIETARY_SUPPLEMENT

45 g milk fat per day in 4 weeks

Also known as: yellow group, Green group

Eligibility Criteria

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

You may qualify if:

  • sign written consent
  • Age: 20-42
  • BMI: 20-30
  • increased risk of developing MS
  • refrain from dietary supplements and blood donations prior to, and during the study

You may not qualify if:

  • poor compliance
  • if they suffering from any chronic or long lasting illness
  • abuse of alcohol or medicine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Human Nutrition

Frederiksberg, 1958, Denmark

Location

Related Publications (1)

  • Werner LB, Hellgren LI, Raff M, Jensen SK, Petersen RA, Drachmann T, Tholstrup T. Effect of dairy fat on plasma phytanic acid in healthy volunteers - a randomized controlled study. Lipids Health Dis. 2011 Jun 10;10:95. doi: 10.1186/1476-511X-10-95.

    PMID: 21663648DERIVED

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Tine Tholstrup, lector

    Department of Human Nutrition, University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 18, 2011

First Posted

April 28, 2011

Study Start

August 1, 2009

Primary Completion

November 1, 2009

Study Completion

December 1, 2010

Last Updated

April 28, 2011

Record last verified: 2009-11

Locations

DK(1)