Pharmacokinetics of Carnosine

This study has been completed.

Sponsor:

Information provided by:

Tufts University

ClinicalTrials.gov Identifier:

NCT00721708

First received: July 22, 2008

Last updated: December 14, 2009

Last verified: December 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

July 22, 2008

Last Updated Date

December 14, 2009

Start Date ^ICMJE

April 2007

Primary Completion Date

October 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Plasma histidine-dipeptide [ Time Frame: 0, 30, 60, 100, 180, 240, & 300 min ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00721708 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Pharmacokinetics of Carnosine

Official Title ^ICMJE

Pharmacokinetics of Carnosine

Brief Summary

The absorption kinetics of dietary carnosine (β-alanyl-L-histidine) will be determined in the healthy adults.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label

Condition ^ICMJE

Oxidative Stress

Intervention ^ICMJE

Dietary Supplement: pure carnosine
one time dose of pure carnosine (450 mg)
Other: Beef
one time dose, 150 g of beef
Other: Chicken
One time dose, 150g of chicken breast
Other: Chicken broth
one time dose of chicken broth obtained from 150g of chicken breast

Study Arm (s)

Experimental: 1
Carnosine(450 mg)

Intervention: Dietary Supplement: pure carnosine
Experimental: 2
Beef (150g)

Intervention: Other: Beef
Experimental: 3
chicken (150g)

Intervention: Other: Chicken
Experimental: 4
Chicken broth (obtained from 150 g of chicken breast)

Intervention: Other: Chicken broth

Publications *

Yeum KJ, Orioli M, Regazzoni L, Carini M, Rasmussen H, Russell RM, Aldini G. Profiling histidine dipeptides in plasma and urine after ingesting beef, chicken or chicken broth in humans. Amino Acids. 2009 Apr 19; [Epub ahead of print]

* 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

Completed

Enrollment ^ICMJE

Completion Date

July 2008

Primary Completion Date

October 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Healthy adult
normal hematological parameters, normal serum albumin, normal liver function, normal kidney function

Exclusion Criteria:

History of smoking or alcoholism

Gender

Female

Ages

40 Years to 70 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00721708

Other Study ID Numbers ^ICMJE

TMC/TUHS IRB 7737

Has Data Monitoring Committee

Responsible Party

Kyung-Jin Yeum, Scientist, Tufts University

Study Sponsor ^ICMJE

Tufts University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Kyung-Jin Yeum, Ph.D.

Tufts Medical Center

Information Provided By

Tufts University

Verification Date

December 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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