Effect of Dairy Fat on Plasma Phytanic Acid in Human

Coronary Heart Disease Clinical Trial

Official title:

Effect of Dairy Fat on Plasma Phytanic Acid in Healthy Volunteers - A Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01343576
• Other study ID #: H-B-2009-052 (Adel)
• Status: Completed
• Phase: N/A
• First received: April 18, 2011
• Last updated: April 26, 2011
• Start date: August 2009
• Est. completion date: December 2010

Study information

• Verified date: November 2009
• 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

The aim of the study is to investigate if cow feeding regimes affects concentration of plasma phytanic acid and risk markers of the metabolic syndrome in human.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• sign written consent

• Age: 20-42

• 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
• Myocardial Ischemia

Intervention

Dietary Supplement:
• milk fat
45 g milk fat per day in 4 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	plasma phytanic acid		before and after the intervention (4 weeks)	No
Secondary	total cholesterol		before and after the intervention (4 weeks)	No
Secondary	LDL cholesterol		before and after the intervention (4 weeks)	No
Secondary	HDL cholesterol		before and after the intervention (4 weeks)	No
Secondary	triacylglycerol		before and after the intervention (4 weeks)	No
Secondary	C-reactive protein		before and after the intervention (4 weeks)	No
Secondary	insulin		before and after the intervention (4 weeks)	No
Secondary	glucose		before and after the intervention (4 weeks)	No
Secondary	fatty acid composition in plasma		before and after the intervention (4 weeks)	No