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Effect of Dairy Fat on Plasma Phytanic Acid in Human

This study has been completed.
Sponsor:
Collaborators:
The Danish Dairy Research Foundation, Denmark
Det Strategiske Forskningsråd
Information provided by:
University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01343576
First received: April 18, 2011
Last updated: April 26, 2011
Last verified: November 2009
History of Changes
  Purpose

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.


Condition Intervention
Coronary Heart Disease
 Dietary Supplement: milk fat

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of Dairy Fat on Plasma Phytanic Acid in Healthy Volunteers - A Randomized Controlled Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • plasma phytanic acid [ Time Frame: before and after the intervention (4 weeks) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • total cholesterol [ Time Frame: before and after the intervention (4 weeks) ] [ Designated as safety issue: No ]
  • LDL cholesterol [ Time Frame: before and after the intervention (4 weeks) ] [ Designated as safety issue: No ]
  • HDL cholesterol [ Time Frame: before and after the intervention (4 weeks) ] [ Designated as safety issue: No ]
  • triacylglycerol [ Time Frame: before and after the intervention (4 weeks) ] [ Designated as safety issue: No ]
  • C-reactive protein [ Time Frame: before and after the intervention (4 weeks) ] [ Designated as safety issue: No ]
  • insulin [ Time Frame: before and after the intervention (4 weeks) ] [ Designated as safety issue: No ]
  • glucose [ Time Frame: before and after the intervention (4 weeks) ] [ Designated as safety issue: No ]
  • fatty acid composition in plasma [ Time Frame: before and after the intervention (4 weeks) ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: August 2009
Study Completion Date: December 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: milk fat
    45 g milk fat per day in 4 weeks
    Other Names:
    • yellow group
    • Green group
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01343576

Locations
Denmark
Department of Human Nutrition
Frederiksberg, Denmark, 1958
Sponsors and Collaborators
University of Copenhagen
The Danish Dairy Research Foundation, Denmark
Det Strategiske Forskningsråd
Investigators
Principal Investigator: Tine Tholstrup, lector Department of Human Nutrition, University of Copenhagen
  More Information

No publications provided by University of Copenhagen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Tine Tholstrup, Dpt Human Nutrition, University of Copenhagen, Denmark
ClinicalTrials.gov Identifier: NCT01343576     History of Changes
Other Study ID Numbers: H-B-2009-052 (Adel)
Study First Received: April 18, 2011
Last Updated: April 26, 2011
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013