Changes of Biomarkers in Response to Training and Antioxidant Treatment - Tabular View

Tracking Information

First Received Date ^ICMJE

March 12, 2008

Last Updated Date

March 12, 2008

Start Date ^ICMJE

March 2008

Estimated Primary Completion Date

April 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

PGC-1alpha mRNA expresion in skeletal muscle PPARgamma mRNA expresion in skeletal muscle Serum malondialdehyde concentration [ Time Frame: after 4 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

body weight glucose infusion rate during the steady state of an eugglycemic-hyperinsulinemic clamp VO2max [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Changes of Biomarkers in Response to Training and Antioxidant Treatment

Official Title ^ICMJE

Effects of Training and Antioxidant Treatment on Circulating Markers of Oxidative Stress and Skeletal Muscle mRNA Expression

Brief Summary

The aim of the study is to compare the effects of an intensive 4 weeks exercise training program with or without additional treatment with antioxidants. 16 volunteers are included into the study and randomized into a treatment (n=8,Vitamine E 400 IU od + vitamine C 1g twice daily) and a non-treatment (n=8, training only) group. Before and after the training program, skeletal muscle biopsies will be taken to measure PGC-1alpha and PPARgamma mRNA expression. In addition before and after the training programm individuals will have the following measurements: body weight, waist circumference, body fat content (DEXA scan), euglycemic-hyperinsulinemic clamps, ergospirometry (VO2 max), routine laboratory measurements, serum malondialdehyde concentrations.

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Basic Science, Randomized, Open Label, Placebo Control, Parallel Assignment

Condition ^ICMJE

Obesity
Type 2 Diabetes

Intervention ^ICMJE

Dietary Supplement: Vitamin C, Vitamin E
Dietary Supplement: Antioxidant treatment

Study Arms / Comparison Groups

Experimental:
Antioxidant treatment arm:

Vitamin E, 400 IU po, once daily Vitamin C, 1g po, twice daily
Placebo Comparator: Control

Publications *

Ristow M, Zarse K, Oberbach A, Klöting N, Birringer M, Kiehntopf M, Stumvoll M, Kahn CR, Blüher M. Antioxidants prevent health-promoting effects of physical exercise in humans. Proc Natl Acad Sci U S A. 2009 May 26;106(21):8665-70. Epub 2009 May 11.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

April 2008

Estimated Primary Completion Date

April 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Must be able to swallow tablets
signed informed consent
no concommittant medication
male
age between 25 - 35 years

Exclusion Criteria:

drug, tobacco or alcohol abuse
any chronic disease
any acute or chronic inflammatory disease as determined by a leucocyte count > 7000 Gpt/l, C-reactive protein (CrP) > 5.0 mg/dl or clinical signs of infection
systolic blood pressure (SBP) > 140mmHg and diastolic blood pressure (DBP) was > 85mmHg
cardiovascular or peripheral artery disease
thyroid dysfunction

Gender

Male

Ages

25 Years to 35 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Matthias Blüher, MD	+49 341 97 ext 15984	bluma@medizin.uni-leipzig.de
Contact: Andreas Oberbach, MD	+49 341 97 ext 22431	andreas.oberbach@medizin.uni-leipzig.de

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00638560

Responsible Party

Prof. Dr. med. Matthias Blüher, Medical Department, University of Leipzig

Study ID Numbers ^ICMJE

MB-MR-2008-290208

Study Sponsor ^ICMJE

University of Leipzig

Collaborators ^ICMJE

University of Jena

Investigators ^ICMJE

Principal Investigator:

Matthias Blüher, MD

University of Leipzig

Information Provided By

University of Leipzig

Verification Date

February 2008

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