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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

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ClinicalTrials.gov Identifier: NCT01343589
Recruitment Status : Completed
First Posted : April 28, 2011
Last Update Posted : April 28, 2011
Sponsor:
Collaborators:
The Danish Dairy Research Foundation, Denmark
Det Strategiske Forskningsråd
Information provided by:
University of Copenhagen

Brief Summary:
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 or disease Intervention/treatment Phase
Coronary Heart Disease Type-2 Diabetes Dietary Supplement: milk fat Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : January 2010
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010



Intervention Details:
    Dietary Supplement: milk fat
    39 g milk fat per day in 12 weeks
    Other Name: Yellow feed


Primary Outcome Measures :
  1. Oral glucose tolerance test [ Time Frame: before and after the intervention (12 weeks) ]
  2. LDL cholesterol [ Time Frame: before and after the intervention (12 weeks) ]
  3. HDL cholesterol [ Time Frame: before and after the intervention (12 weeks) ]
  4. Total cholesterol [ Time Frame: before and after the intervention (12 weeks) ]
  5. Triacylglycerol [ Time Frame: before and after the intervention (12 weeks) ]
  6. C-reactive protein [ Time Frame: before and after the intervention (12 weeks) ]
  7. fatty acid composition in plasma [ Time Frame: before and after the intervention (12 weeks) ]

Secondary Outcome Measures :
  1. phytanic acid [ Time Frame: before and after the intervention (12 weeks) ]


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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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: NCT01343589     History of Changes
Other Study ID Numbers: H-B-2009-052 (B del)
First Posted: April 28, 2011    Key Record Dates
Last Update Posted: April 28, 2011
Last Verified: June 2010

Additional relevant MeSH terms:
Heart Diseases
Metabolic Syndrome X
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases