Cheese and Human Health

Cardiovascular Disease Clinical Trial

Official title:

Effects of Hard Cheese and Butter on Markers of Cardiovascular Disease -A Randomized Controlled Dietary Human Intervention

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01140165
• Other study ID #: A308
• Status: Active, not recruiting
• Phase: N/A
• First received: June 4, 2010
• Last updated: June 8, 2010
• Start date: January 2010
• Est. completion date: December 2011

Study information

• Verified date: October 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 this study is to examine if a diet rich in cheese will have a beneficial effect on risk markers of cardiovascular disease compared to a diet rich in butter.

The primary parameters are total cholesterol as well as LDL-, HDL cholesterol and triacylglycerol (TAG). The secondary parameters are hsCRP, markers of insulin resistance, fasting insulin and glucose (HOMA). Furthermore bloodpressure is measured.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• Sign written consent

• Age: 20-70

• BMI: 20-32

• Refrain from dietary supplements and blood donations prior to, and during the study

Exclusion Criteria:

• Known or suspected abuse of alcohol, drugs or medication

• Poor compliance

• Current or previously cardiovascular disease

• Diabetes Mellitus or other severe chronic disease, including severe allergies

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Other:
• cheese
the effect of cheese intake versus butter intake on blood lipids (primarily)

Locations

Country	Name	City	State
Denmark	Department of Human Nutrition	Frederiksberg

Sponsors (3)

Lead Sponsor	Collaborator
University of Copenhagen	National Dairy Council, The Danish Dairy Research Foundation, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total cholesterol		6 weeks	No
Primary	LDL cholesterol		6 weeks	No
Primary	HDL cholesterol		6 weeks	No
Primary	Triglyceride		6 weeks	No
Secondary	Insulin		6 weeks	No
Secondary	Glucose		6 weeks	No
Secondary	fasting hsCRP		6 weeks	No
Secondary	Blood pressure		6 weeks	No