Changes of Biomarkers in Response to Training and Antioxidant Treatment

Phase 1

Completed

• Conditions: Obesity; Type 2 Diabetes
• Interventions: Dietary Supplement: Vitamin C, Vitamin E; Dietary Supplement: Antioxidant treatment

• Registration Number: NCT00638560
• Lead Sponsor: University of Leipzig

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-03-12
• Study First Submitted QC: 2008-03-12
• Study First Posted: 2008-03-19
• Primary Completion: 2008-10
• Study Completion: 2008-12
• Status Verified: 2009-02
• Last Update Submitted: 2010-01-19
• Last Update Posted: 2010-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Vitamin C, Vitamin E	Antioxidant treatment arm: Vitamin E, 400 IU po, once daily Vitamin C, 1g po, twice daily
2	Antioxidant treatment	Control

Primary Outcome Measures

Name	Time	Method
PGC-1alpha mRNA expression in skeletal muscle PPARgamma mRNA expression in skeletal muscle Serum malondialdehyde concentration	after 4 weeks

Secondary Outcome Measures

Name	Time	Method
body weight glucose infusion rate during the steady state of an euglycemic-hyperinsulinemic clamp VO2max	4 weeks

Trial Locations

Locations (1)

University of Leipzig; 🇩🇪 Leipzig, Germany