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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 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: 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 August 19, 2014