Text Size

Changes of Biomarkers in Response to Training and Antioxidant Treatment

This study has been completed.
Sponsor:
Collaborator:
University of Jena
Information provided by:
University of Leipzig
ClinicalTrials.gov Identifier:
NCT00638560
First received: March 12, 2008
Last updated: January 19, 2010
Last verified: February 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Obesity
Type 2 Diabetes
 Dietary Supplement: Vitamin C, Vitamin E
Dietary Supplement: Antioxidant treatment
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Training and Antioxidant Treatment on Circulating Markers of Oxidative Stress and Skeletal Muscle mRNA Expression

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Leipzig:

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

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

Enrollment: 40
Study Start Date: March 2008
Study Completion Date: December 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo Comparator: 2
Control
 Dietary Supplement: Antioxidant treatment
no treatment

  Eligibility

Ages Eligible for Study:   25 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00638560

Locations
Germany
University of Leipzig
Leipzig, Germany, 04103
Sponsors and Collaborators
University of Leipzig
University of Jena
Investigators
Principal Investigator: Matthias Blüher, MD University of Leipzig
  More Information

No publications provided by University of Leipzig

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Prof. Dr. med. Matthias Blüher, Medical Department, University of Leipzig
ClinicalTrials.gov Identifier: NCT00638560     History of Changes
Other Study ID Numbers: MB-MR-2008-290208
Study First Received: March 12, 2008
Last Updated: January 19, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Leipzig:
PGC-1alpha
PPARgamma
oxidative stress
training intervention

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Obesity
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Antioxidants
 Ascorbic Acid
Vitamin E
Alpha-Tocopherol
Tocopherols
Tocotrienols
Vitamins
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 16, 2013