ObesityPhase 1NCT00638560
Changes of Biomarkers in Response to Training and Antioxidant Treatment
A Phase 1 study testing Vitamin C, Vitamin E and Antioxidant treatment in people with Obesity and Type 2 Diabetes, run by University of Leipzig at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 25 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Type 2 Diabetes
- What is being tested?
- Vitamin C, Vitamin E and Antioxidant treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2008to Dec 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must be able to swallow tablets
- signed informed consent
- no concommitant medication
- male
- age between 25 - 35 years
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Training and Antioxidant Treatment on Circulating Markers of Oxidative Stress and Skeletal Muscle mRNA Expression
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.
- Conditions
- Obesity, Type 2 Diabetes
- Being tested
- Vitamin C, Vitamin E, Antioxidant treatment
- Keywords
- PGC-1alpha, PPARgamma, oxidative stress, training intervention
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Carotid Intimal Medial Thickness 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin C, Vitamin EDietary supplement
Vitamin C, 1g po, twice daily Vitamin E, 400 IU po, once daily
Antioxidant treatmentDietary supplement
no treatment
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Antioxidant treatment arm:
Vitamin E, 400 IU po, once daily Vitamin C, 1g po, twice daily Receives: Dietary Supplement: Vitamin C, Vitamin E |
| 2 | Placebo comparator | Control Receives: Dietary Supplement: Antioxidant treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
PGC-1alpha mRNA expression in skeletal muscle PPARgamma mRNA expression in skeletal muscle Serum malondialdehyde concentration
Measured: after 4 weeks
Secondary outcomes (1)
body weight glucose infusion rate during the steady state of an euglycemic-hyperinsulinemic clamp VO2max
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionOct 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Collaborators
- University of Jena
- Investigators
- Matthias Blüher, MD, Principal investigator, University of Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00638560
- Sponsor's protocol ID
- MB-MR-2008-290208
- Status last verified
- Feb 2009
- First submitted
- 12 Mar 2008
- Last updated
- 20 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19433800
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Training and Antioxidant Treatment on Circulating Markers of Oxidative Stress and Skeletal Muscle mRNA Expression
- ClinicalTrials.gov ID
- NCT00638560
- Acronym / sponsor ID
- MB-MR-2008-290208
- Conditions
- Obesity, Type 2 Diabetes
- Keywords
- PGC-1alpha, PPARgamma, oxidative stress, training intervention
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Collaborators
- University of Jena
- Study start
- Mar 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 19 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Vitamin C, Vitamin EAntioxidant treatment arm: Vitamin E, 400 IU po, once daily Vitamin C, 1g po, twice daily |
| 2 | Placebo comparator | Dietary Supplement: Antioxidant treatmentControl |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Must be able to swallow tablets
- signed informed consent
- no concommitant medication
- male
- age between 25 - 35 years
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin C, Vitamin EVitamin C, 1g po, twice daily Vitamin E, 400 IU po, once daily | Dietary supplement | 1 |
| Antioxidant treatmentno treatment | Dietary supplement | 2 |
Primary outcome
PGC-1alpha mRNA expression in skeletal muscle PPARgamma mRNA expression in skeletal muscle Serum malondialdehyde concentration
Time frame: after 4 weeks
1 secondary outcome
body weight glucose infusion rate during the steady state of an euglycemic-hyperinsulinemic clamp VO2max
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2010.
- Derived from this study: PubMed 19433800Ristow 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias Blüher, MD principal investigator
University of Leipzig
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vitamin C, Vitamin E and Antioxidant treatment in people with Obesity and Type 2 Diabetes, run by University of Leipzig at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PGC-1alpha mRNA expression in skeletal muscle PPARgamma mRNA expression in skeletal muscle Serum malondialdehyde concentration (time frame: after 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00638560, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2010.