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Effects of Milk Derived From Mountain-pasture Grazing Cows on Risk Markers of the Metabolic Syndrome Compared to Conventional Danish Milk

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:
NCT01343589
First received: April 18, 2011
Last updated: April 27, 2011
Last verified: June 2010
History of Changes
  Purpose

To investigate the effect of milk delivered from mountain-pasture grazing cows on risk markers of the metabolic syndrome and type-2 diabetes with the effect of conventional Danish milk. The study should reveal the importance of phytanic acid content for these effects.


Condition Intervention
Coronary Heart Disease
Type-2 Diabetes
 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: Effects of Milk Derived From Mountain-pasture Grazing Cows on Risk Markers of the Metabolic Syndrome Compared to Conventional Danish Milk

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • Oral glucose tolerance test [ Time Frame: before and after the intervention (12 weeks) ] [ Designated as safety issue: No ]
  • LDL cholesterol [ Time Frame: before and after the intervention (12 weeks) ] [ Designated as safety issue: No ]
  • HDL cholesterol [ Time Frame: before and after the intervention (12 weeks) ] [ Designated as safety issue: No ]
  • Total cholesterol [ Time Frame: before and after the intervention (12 weeks) ] [ Designated as safety issue: No ]
  • Triacylglycerol [ Time Frame: before and after the intervention (12 weeks) ] [ Designated as safety issue: No ]
  • C-reactive protein [ Time Frame: before and after the intervention (12 weeks) ] [ Designated as safety issue: No ]
  • fatty acid composition in plasma [ Time Frame: before and after the intervention (12 weeks) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • phytanic acid [ Time Frame: before and after the intervention (12 weeks) ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: January 2010
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: milk fat
    39 g milk fat per day in 12 weeks
    Other Name: Yellow feed
  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • sign written consent
  • Age: 50-70
  • 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: NCT01343589

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

Responsible Party: Tine Tholstrup, Dpt Human Nutrition, University of Copenhagen, Denmark
ClinicalTrials.gov Identifier: NCT01343589     History of Changes
Other Study ID Numbers: H-B-2009-052 (B del)
Study First Received: April 18, 2011
Last Updated: April 27, 2011
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Diabetes Mellitus, Type 2
Heart Diseases
Metabolic Syndrome X
Cardiovascular Diseases
Arteriosclerosis
 Arterial Occlusive Diseases
Vascular Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Resistance
Hyperinsulinism

ClinicalTrials.gov processed this record on May 23, 2013