The Protein (Meat) and Function Study | NCT00621231

Studies
The Protein (Meat) and Function Study

NCT00621231

Sponsor

University of Copenhagen

Status

Completed

Last Update Posted

Feb 22, 2008Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Healthy

Interventions

Placebo
Protein

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

May 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Dec 2007Actual

Completion Date

Apr 2008

First Submitted Date

Feb 12, 2008

First Submission Date that Met QC Criteria

Feb 21, 2008

First Posted Date

Feb 22, 2008Estimated

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

Feb 21, 2008

Last Update Posted Date

Feb 22, 2008Estimated

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 the proposed study is to investigate the effects of different amounts of protein intake primarily from meat on muscle function, immune response, mental function, proteomics, biochemical regulators of protein metabolism, energy expenditure, and composition in young healthy males.

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

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Placebo Comparator		Dietary Supplement: Placebo
2	Experimental		Dietary Supplement: Protein

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Dietary Supplement	Placebo	1
Protein

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy males, 19-40 y/o

Exclusion Criteria:

Smokers

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of human nutrition		Copenhagen	DK-Frederiksberg C	1958	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21239090	Derived	Jakobsen LH, Kondrup J, Zellner M, Tetens I, Roth E. Effect of a high protein meat diet on muscle and cognitive functions: a randomised controlled dietary intervention trial in healthy men. Clin Nutr. 2011 Jun;30(3):303-11. doi: 10.1016/j.clnu.2010.12.010. Epub 2011 Jan 15.