Changes of Biomarkers in Response to Training and Antioxidant Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2008-12-31

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.

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Detailed Description

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Conditions

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Obesity Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Antioxidant treatment arm:

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

Group Type EXPERIMENTAL

Vitamin C, Vitamin E

Intervention Type DIETARY_SUPPLEMENT

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

2

Control

Group Type PLACEBO_COMPARATOR

Antioxidant treatment

Intervention Type DIETARY_SUPPLEMENT

no treatment

Interventions

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Vitamin C, Vitamin E

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

Intervention Type DIETARY_SUPPLEMENT

Antioxidant treatment

no treatment

Intervention Type DIETARY_SUPPLEMENT

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

Minimum Eligible Age

25 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes