Changes of Biomarkers in Response to Training and Antioxidant Treatment

January 19, 2010 updated by: University of Leipzig

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

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 program individuals will have the following measurements: body weight, waist circumference, body fat content (DEXA scan), euglycemic-hyperinsulinemic clamps, ergospirometer (VO2 max), routine laboratory measurements, serum malondialdehyde concentrations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Leipzig, Germany, 04103
        • University of Leipzig

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Must be able to swallow tablets
  • signed informed consent
  • no concommitant 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Control
Dietary supplement: Antioxidant treatment
no treatment
Experimental: 1

Antioxidant treatment arm:

Vitamin E, 400 IU po, once daily Vitamin C, 1g po, twice daily
Dietary supplement: Vitamin C, Vitamin E
Vitamin C, 1g po, twice daily Vitamin E, 400 IU po, once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PGC-1alpha mRNA expression in skeletal muscle PPARgamma mRNA expression in skeletal muscle Serum malondialdehyde concentration
Time Frame: after 4 weeks
after 4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
body weight glucose infusion rate during the steady state of an euglycemic-hyperinsulinemic clamp VO2max
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leipzig

Collaborators

University of Jena

Investigators

  • Principal Investigator: Matthias Blüher, MD, University of Leipzig

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

March 12, 2008

First Submitted That Met QC Criteria

March 12, 2008

First Posted (Estimate)

March 19, 2008

Study Record Updates

Last Update Posted (Estimate)

January 20, 2010

Last Update Submitted That Met QC Criteria

January 19, 2010

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MB-MR-2008-290208

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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