Changes of Biomarkers in Response to Training and Antioxidant Treatment

University of Leipzig

Status and phase: Completed; Phase 1

Conditions: Obesity; Type 2 Diabetes

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00638560

MB-MR-2008-290208

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: Male

Ages: 25 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Antioxidant treatment arm: Vitamin E, 400 IU po, once daily Vitamin C, 1g po, twice daily

Treatment:

Dietary Supplement: Vitamin C, Vitamin E

2

Placebo Comparator group

Description:

Control

Treatment:

Dietary Supplement: Antioxidant treatment