Changes of Biomarkers in Response to Training and Antioxidant Treatment

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00638560
• Other study ID #: MB-MR-2008-290208
• Status: Completed
• Phase: Phase 1
• First received: March 12, 2008
• Last updated: January 19, 2010
• Start date: March 2008
• Est. completion date: December 2008

Study information

• Verified date: February 2009
• Source: University of Leipzig
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 25 Years to 35 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Obesity
• Type 2 Diabetes

Intervention

Dietary Supplement:
• Vitamin C, Vitamin E
Vitamin C, 1g po, twice daily Vitamin E, 400 IU po, once daily
• Antioxidant treatment
no treatment

Locations

Country	Name	City	State
Germany	University of Leipzig	Leipzig

Sponsors (2)

Lead Sponsor	Collaborator
University of Leipzig	University of Jena

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PGC-1alpha mRNA expression in skeletal muscle PPARgamma mRNA expression in skeletal muscle Serum malondialdehyde concentration		after 4 weeks	No
Secondary	body weight glucose infusion rate during the steady state of an euglycemic-hyperinsulinemic clamp VO2max		4 weeks	No