NCT00638560

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_1 obesity

Timeline
Completed

Started Mar 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 19, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

January 20, 2010

Status Verified

February 1, 2009

Enrollment Period

7 months

First QC Date

March 12, 2008

Last Update Submit

January 19, 2010

Conditions

ObesityType 2 Diabetes

Keywords

PGC-1alphaPPARgammaoxidative stresstraining intervention

Outcome Measures

Primary Outcomes (1)

  • PGC-1alpha mRNA expression in skeletal muscle PPARgamma mRNA expression in skeletal muscle Serum malondialdehyde concentration

    after 4 weeks

Secondary Outcomes (1)

  • body weight glucose infusion rate during the steady state of an euglycemic-hyperinsulinemic clamp VO2max

    4 weeks

Study Arms (2)

1

EXPERIMENTAL

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

Dietary Supplement: Vitamin C, Vitamin E

2

PLACEBO COMPARATOR

Control

Dietary Supplement: Antioxidant treatment

Interventions

Vitamin C, Vitamin EDIETARY_SUPPLEMENT

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

1
Antioxidant treatmentDIETARY_SUPPLEMENT

no treatment

2

Eligibility Criteria

Age25 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Must be able to swallow tablets
  • signed informed consent
  • no concommitant medication
  • male
  • age between 25 - 35 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Leipzig

Leipzig, 04103, Germany

Location

Related Publications (1)

  • Ristow M, Zarse K, Oberbach A, Kloting N, Birringer M, Kiehntopf M, Stumvoll M, Kahn CR, Bluher M. Antioxidants prevent health-promoting effects of physical exercise in humans. Proc Natl Acad Sci U S A. 2009 May 26;106(21):8665-70. doi: 10.1073/pnas.0903485106. Epub 2009 May 11.

    PMID: 19433800DERIVED

MeSH Terms

Conditions

ObesityDiabetes Mellitus, Type 2Carotid Intimal Medial Thickness 1

Interventions

Ascorbic AcidVitamin E

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydratesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Matthias Blüher, MD

    University of Leipzig

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 12, 2008

First Posted

March 19, 2008

Study Start

March 1, 2008

Primary Completion

October 1, 2008

Study Completion

December 1, 2008

Last Updated

January 20, 2010

Record last verified: 2009-02

Locations

DE(1)