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

Coronary Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01343589
• Other study ID #: H-B-2009-052 (B del)
• Status: Completed
• Phase: N/A
• First received: April 18, 2011
• Last updated: April 27, 2011
• Start date: January 2010
• Est. completion date: June 2010

Study information

• Verified date: June 2010
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Metabolic Syndrome X
• Myocardial Ischemia
• Type-2 Diabetes

Intervention

Dietary Supplement:
• milk fat
39 g milk fat per day in 12 weeks

Locations

Country	Name	City	State
Denmark	Department of Human Nutrition	Frederiksberg

Sponsors (3)

Lead Sponsor	Collaborator
University of Copenhagen	Det Strategiske Forskningsråd, The Danish Dairy Research Foundation, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral glucose tolerance test		before and after the intervention (12 weeks)	No
Primary	LDL cholesterol		before and after the intervention (12 weeks)	No
Primary	HDL cholesterol		before and after the intervention (12 weeks)	No
Primary	Total cholesterol		before and after the intervention (12 weeks)	No
Primary	Triacylglycerol		before and after the intervention (12 weeks)	No
Primary	C-reactive protein		before and after the intervention (12 weeks)	No
Primary	fatty acid composition in plasma		before and after the intervention (12 weeks)	No
Secondary	phytanic acid		before and after the intervention (12 weeks)	No