Back to resultsEffect of Dairy Fat on Plasma Phytanic Acid in Human
Primary Purpose
Coronary Heart Disease
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
milk fat
Sponsored by
About this trial
This is an interventional basic science trial for Coronary Heart Disease
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- poor compliance
- if they suffering from any chronic or long lasting illness
- abuse of alcohol or medicine
Sites / Locations
- Department of Human Nutrition
Outcomes
Primary Outcome Measures
plasma phytanic acid
Secondary Outcome Measures
total cholesterol
LDL cholesterol
HDL cholesterol
triacylglycerol
C-reactive protein
insulin
glucose
fatty acid composition in plasma
Full Information
NCT ID
NCT01343576
First Posted
April 18, 2011
Last Updated
April 26, 2011
Sponsor
University of Copenhagen
Collaborators
The Danish Dairy Research Foundation, Denmark, The Danish Council for Strategic Research
1. Study Identification
Unique Protocol Identification Number
NCT01343576
Brief Title
Effect of Dairy Fat on Plasma Phytanic Acid in Human
Official Title
Effect of Dairy Fat on Plasma Phytanic Acid in Healthy Volunteers - A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Copenhagen
Collaborators
The Danish Dairy Research Foundation, Denmark, The Danish Council for Strategic Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Dietary Supplement
Intervention Name(s)
milk fat
Other Intervention Name(s)
yellow group, Green group
Intervention Description
45 g milk fat per day in 4 weeks
Primary Outcome Measure Information:
Title
plasma phytanic acid
Time Frame
before and after the intervention (4 weeks)
Secondary Outcome Measure Information:
Title
total cholesterol
Time Frame
before and after the intervention (4 weeks)
Title
LDL cholesterol
Time Frame
before and after the intervention (4 weeks)
Title
HDL cholesterol
Time Frame
before and after the intervention (4 weeks)
Title
triacylglycerol
Time Frame
before and after the intervention (4 weeks)
Title
C-reactive protein
Time Frame
before and after the intervention (4 weeks)
Title
insulin
Time Frame
before and after the intervention (4 weeks)
Title
glucose
Time Frame
before and after the intervention (4 weeks)
Title
fatty acid composition in plasma
Time Frame
before and after the intervention (4 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
poor compliance
if they suffering from any chronic or long lasting illness
abuse of alcohol or medicine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tine Tholstrup, lector
Organizational Affiliation
Department of Human Nutrition, University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Human Nutrition
City
Frederiksberg
ZIP/Postal Code
1958
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
21663648
Citation
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.
Results Reference
derived
Learn more about this trial
Effect of Dairy Fat on Plasma Phytanic Acid in Human
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