Effect of β-alanine Supplementation on Muscle Carnosine | NCT00813553

Studies
Effect of β-alanine Supplementation on Muscle Carnosine

NCT00813553

Sponsor

Société des Produits Nestlé (SPN)

Status

Completed

Last Update Posted

Apr 25, 2012Estimated

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Healthy

Interventions

placebo
beta-alanine
beta-alanine

Countries

Switzerland

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

Apr 2012

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

Dec 2008

Primary Completion Date

Oct 2009Actual

Completion Date

Oct 2009Actual

First Submitted Date

Dec 22, 2008

First Submission Date that Met QC Criteria

Dec 22, 2008

First Posted Date

Dec 23, 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

Apr 24, 2012

Last Update Posted Date

Apr 25, 2012Estimated

Name	Class
University of Bern	OTHER
Insel Gruppe AG, University Hospital Bern	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

Carnosine is a natural acid buffering substance of muscle. The primary objective of this study is to test whether a nutritional supplement of beta-alanine enhances carnosine content in muscle.

Detailed Description

Volunteers will be randomized to receiving 3 nutritional supplements. Two supplements contain beta-alanine at different doses, the third supplement is a placebo.

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

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
beta-alanine 0	Placebo Comparator	Dietary Supplement: placebo
beta-alanine 1	Experimental	Dietary Supplement: beta-alanine
beta-alanine 2	Experimental	Dietary Supplement: beta-alanine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
placebo	Dietary Supplement	daily	beta-alanine 0
beta-alanine

Measure	Description	Time Frame
muscle carnosine concentration		0 to 8 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Stable health as evaluated by medical evaluation
Body mass index higher than 18 kg/m2
Body mass index lower than 25 kg/m2, unless body fat is less than 20%

Exclusion Criteria:

intolerance to β-alanine,
allergy to soy, fish and crustacean
participation in another intervention study
consumer of dietary supplement susceptible to contain beta-alanine
determined to have very high baseline muscle carnosine concentration

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 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
University and Inselspital		Bern	Canton of Bern	3010	Switzerland

ID	Term
D009043	Motor Activity

ID	Term
D001519	Behavior

Intervention Browse Module

MeSH Terms

ID	Term
D015091	beta-Alanine

Ancestor Terms

ID	Term
D000409	Alanine
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins

Browse Leaves

Not provided

Browse Branches

Not provided