Cheese and Human Health
Effects of Hard Cheese and Butter on Markers of Cardiovascular Disease -A Randomized Controlled Dietary Human Intervention
1 other identifier
interventional
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 4, 2010
CompletedFirst Posted
Study publicly available on registry
June 9, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedJune 9, 2010
October 1, 2009
5 months
June 4, 2010
June 8, 2010
Conditions
Outcome Measures
Primary Outcomes (4)
Total cholesterol
6 weeks
LDL cholesterol
6 weeks
HDL cholesterol
6 weeks
Triglyceride
6 weeks
Secondary Outcomes (4)
Insulin
6 weeks
Glucose
6 weeks
fasting hsCRP
6 weeks
Blood pressure
6 weeks
Study Arms (2)
butter
ACTIVE COMPARATORDanish butter
cheese
EXPERIMENTALInterventions
the effect of cheese intake versus butter intake on blood lipids (primarily)
Eligibility Criteria
You may qualify if:
- Sign written consent
- Age: 20-70
- BMI: 20-32
- Refrain from dietary supplements and blood donations prior to, and during the study
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Copenhagenlead
- The Danish Dairy Research Foundation, Denmarkcollaborator
- National Dairy Councilcollaborator
Study Sites (1)
Department of Human Nutrition
Frederiksberg, Denmark
Related Publications (1)
Hjerpsted J, Leedo E, Tholstrup T. Cheese intake in large amounts lowers LDL-cholesterol concentrations compared with butter intake of equal fat content. Am J Clin Nutr. 2011 Dec;94(6):1479-84. doi: 10.3945/ajcn.111.022426. Epub 2011 Oct 26.
PMID: 22030228DERIVED
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tine Tholstrup, PhD
Department of Human Nutrition, University of Copenhagen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 4, 2010
First Posted
June 9, 2010
Study Start
January 1, 2010
Primary Completion
June 1, 2010
Study Completion
December 1, 2011
Last Updated
June 9, 2010
Record last verified: 2009-10