Cheese and Human Health
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by University of Copenhagen.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
University of Copenhagen
Collaborators:
The Danish Dairy Research Foundation, Denmark
National Dairy Council
Information provided by:
University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01140165
First received: June 4, 2010
Last updated: June 8, 2010
Last verified: October 2009
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | June 4, 2010 | ||||
| Last Updated Date | June 8, 2010 | ||||
| Start Date ICMJE | January 2010 | ||||
| Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
|
||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01140165 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
|
||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Cheese and Human Health | ||||
| Official Title ICMJE | Effects of Hard Cheese and Butter on Markers of Cardiovascular Disease -A Randomized Controlled Dietary Human Intervention | ||||
| 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. |
||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science |
||||
| Condition ICMJE | Cardiovascular Disease | ||||
| Intervention ICMJE | Other: cheese
the effect of cheese intake versus butter intake on blood lipids (primarily)
Other Name: cheese, butter, dairy |
||||
| Study Arm (s) |
|
||||
| Publications * | 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. Epub 2011 Oct 26. | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 60 | ||||
| Estimated Completion Date | December 2011 | ||||
| Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 20 Years to 70 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Denmark | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01140165 | ||||
| Other Study ID Numbers ICMJE | A308 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Tine Tholstrup, Dpt Human Nutrition, University of Copenhagen, Denmark | ||||
| Study Sponsor ICMJE | University of Copenhagen | ||||
| Collaborators ICMJE |
|
||||
| Investigators ICMJE |
|
||||
| Information Provided By | University of Copenhagen | ||||
| Verification Date | October 2009 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||