Changes of Biomarkers in Response to Training and Antioxidant Treatment

Study Overview
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Brief Summary
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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.

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

Conditions
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Obesity, Type 2 Diabetes

Intervention / Treatment
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* Dietary Supplement: Vitamin C, Vitamin E
* Dietary Supplement: Antioxidant treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Antioxidant treatment arm: Vitamin E, 400 IU po, once daily Vitamin C, 1g po, twice daily | Dietary Supplement: Vitamin C, Vitamin E<br>* Vitamin C, 1g po, twice daily Vitamin E, 400 IU po, once daily<br>|
| Placebo Comparator: 2<br>Control | Dietary Supplement: Antioxidant treatment<br>* no treatment<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PGC-1alpha, PPARgamma, oxidative stress, training intervention