Cheese and Human Health | NCT01140165

Studies
Cheese and Human Health

NCT01140165

Sponsor

University of Copenhagen

Status

Unknown status

Last Update Posted

Jun 9, 2010Estimated

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Cardiovascular Disease

Interventions

cheese

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Jun 2010Estimated

Completion Date

Dec 2011Estimated

First Submitted Date

Jun 4, 2010

First Submission Date that Met QC Criteria

Jun 8, 2010

First Posted Date

Jun 9, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 8, 2010

Last Update Posted Date

Jun 9, 2010Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

University of CopenhagenOTHER

Collaborators

Name	Class
The Danish Dairy Research Foundation, Denmark	OTHER
National Dairy Council	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
butter	Active Comparator	Danish butter	Other: cheese
cheese	Experimental		Other: cheese

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cheese	Other	the effect of cheese intake versus butter intake on blood lipids (primarily)	butter cheese

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total cholesterol		6 weeks
LDL cholesterol		6 weeks
HDL cholesterol		6 weeks
Triglyceride		6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Insulin		6 weeks
Glucose		6 weeks
fasting hsCRP

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tine Tholstrup, PhD	Department of Human Nutrition, University of Copenhagen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Human Nutrition		Frederiksberg			Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22030228	Derived	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.

ID	Term
D002611	Cheese
D002079	Butter

ID	Term
D043302	Cultured Milk Products
D008892	Milk
D001628	Beverages
D000066888	Diet, Food, and Nutrition