Effects of Milk Derived From Mountain-pasture Grazing Cows on Risk Markers of the Metabolic Syndrome Compared to Conventional Danish Milk
Primary Purpose
Coronary Heart Disease, Type-2 Diabetes
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: 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
Sites / Locations
- Department of Human Nutrition
Outcomes
Primary Outcome Measures
Oral glucose tolerance test
LDL cholesterol
HDL cholesterol
Total cholesterol
Triacylglycerol
C-reactive protein
fatty acid composition in plasma
Secondary Outcome Measures
phytanic acid
Full Information
NCT ID
NCT01343589
First Posted
April 18, 2011
Last Updated
April 27, 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
NCT01343589
Brief Title
Effects of Milk Derived From Mountain-pasture Grazing Cows on Risk Markers of the Metabolic Syndrome Compared to Conventional Danish Milk
Official Title
Effects of Milk Derived From Mountain-pasture Grazing Cows on Risk Markers of the Metabolic Syndrome Compared to Conventional Danish Milk
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease, Type-2 Diabetes
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Dietary Supplement
Intervention Name(s)
milk fat
Other Intervention Name(s)
Yellow feed
Intervention Description
39 g milk fat per day in 12 weeks
Primary Outcome Measure Information:
Title
Oral glucose tolerance test
Time Frame
before and after the intervention (12 weeks)
Title
LDL cholesterol
Time Frame
before and after the intervention (12 weeks)
Title
HDL cholesterol
Time Frame
before and after the intervention (12 weeks)
Title
Total cholesterol
Time Frame
before and after the intervention (12 weeks)
Title
Triacylglycerol
Time Frame
before and after the intervention (12 weeks)
Title
C-reactive protein
Time Frame
before and after the intervention (12 weeks)
Title
fatty acid composition in plasma
Time Frame
before and after the intervention (12 weeks)
Secondary Outcome Measure Information:
Title
phytanic acid
Time Frame
before and after the intervention (12 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
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
23842081
Citation
Werner LB, Hellgren LI, Raff M, Jensen SK, Petersen RA, Drachmann T, Tholstrup T. Effects of butter from mountain-pasture grazing cows on risk markers of the metabolic syndrome compared with conventional Danish butter: a randomized controlled study. Lipids Health Dis. 2013 Jul 10;12:99. doi: 10.1186/1476-511X-12-99.
Results Reference
derived
Learn more about this trial
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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