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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
Sponsor:
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
  Purpose

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.


Condition Intervention
Cardiovascular Disease
Other: cheese

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Effects of Hard Cheese and Butter on Markers of Cardiovascular Disease -A Randomized Controlled Dietary Human Intervention

Resource links provided by NLM:


Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • Total cholesterol [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • LDL cholesterol [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • HDL cholesterol [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Triglyceride [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Insulin [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Glucose [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • fasting hsCRP [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: January 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: butter
Danish butter
Other: cheese
the effect of cheese intake versus butter intake on blood lipids (primarily)
Other Name: cheese, butter, dairy
Experimental: cheese Other: cheese
the effect of cheese intake versus butter intake on blood lipids (primarily)
Other Name: cheese, butter, dairy

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01140165

Locations
Denmark
Department of Human Nutrition
Frederiksberg, Denmark
Sponsors and Collaborators
University of Copenhagen
The Danish Dairy Research Foundation, Denmark
National Dairy Council
Investigators
Principal Investigator: Tine Tholstrup, PhD Department of Human Nutrition, University of Copenhagen
  More Information

No publications provided by University of Copenhagen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tine Tholstrup, Dpt Human Nutrition, University of Copenhagen, Denmark
ClinicalTrials.gov Identifier: NCT01140165     History of Changes
Other Study ID Numbers: A308
Study First Received: June 4, 2010
Last Updated: June 8, 2010
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014