FatigueNCT01424904
DGB-01 Effects on Endurance Exercise
A study testing DGB-01 Supplementation in people with Fatigue, run by William Black at 1 site in United States.
Trial summary
The purpose of this research is to evaluate the effects of DGB-01 on performance of a 40-km time trial in trained male cyclists. The investigators believe that DGB-01 will improve performance on the time trial as measured by a reduction in the amount of time required to complete the distance, using a computerized… Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Fatigue
- What is being tested?
- DGB-01 Supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Jun 2013
- Phase
- Interventional
- 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 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males who are trained cyclists with a maximal oxygen uptake relative to body weight equal to or greater than 45 ml O2/kg/min.
- Subjects must be in the competitive phase of their annual training cycle.
- Between ages of 18-60
- Availability- commitment of the subject/expected participation in the study for 97 days.
Who cannot join
- Specific allergy to milk proteins (this is different from lactose intolerance)
- Use of immunosuppressive medication in the case of organ transplants
- Planned surgeries.
- Kidney disorders
- Use of antihypertensive medications
- Cardiovascular disease
Show all 11Show fewer
- Abnormal BUN, creatinine, hemoglobin, or hematocrit
- Body weight greater than 285 pounds
- A protein-restricted diet
- Subjects currently using dry whey protein supplements, N-acetylcysteine, or alpha-lipoic acid supplements. The wash-out period is 1 month for any of these supplements.
- All medications that can interfere with muscle mass such as corticosteroids (e.g. prednisone), testosterone replacement or anabolic drugs such as Megace
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Clinical and Translational Science
Lexington, Kentucky, 40536
About this study
The purpose of this research is to evaluate the effects of DGB-01 on performance of a 40-km time trial in trained male cyclists. The investigators believe that DGB-01 will improve performance on the time trial as measured by a reduction in the amount of time required to complete the distance, using a computerized cycle ergometer.
- Conditions
- Fatigue
- Being tested
- DGB-01 Supplementation
- Keywords
- Ergogenic aid, Exercise endurance, High performance, Time trial performance, Glutathione
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DGB-01 SupplementationDietary supplement
Approximately one-half of the subjects will initially receive DGB-01. The other half of the subjects will receive casein. Investigators and subjects are blinded to the product the subject is receiving. Subjects will be asked to consume one pouch of their assigned study product twice daily for four weeks.
Subsequently, all subjects will undergo a supplement-free washout period of at least four weeks duration. Following the washout period, the subjects who originally received DGB-01 will receive casein and the subjects who originally received casein will receive DGB-01. Subjects will be asked to consume one pouch of their assigned study product twice daily for four weeks.
| Study group | Role | What they receive |
|---|---|---|
| DGB-01 | Experimental | All subjects will receive DGB-01 during the study. Approximately one-half of the subjects during the first period and the other half during the second period. Receives: Dietary Supplement: DGB-01 Supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy of DGB-01 in promoting exercise endurance will be measured by cycling performance on a standardized 40-km time trial course.
Time to complete the 40km time trial for subjects with DGB-01 intervention in period 1 (minimum 4 weeks of supplementation) versus the time for time trial completion of these subjects with casein in period 2 (minimum of 4 weeks of supplementation); Between the two periods with supplementation, there will be a washout period of a minimum 4 weeks; Results of time trial for subjects with DGB-01 intervention in period 2 (minimum 4 weeks of supplementation) versus the time trial completion of these subjects with casein in period 1 (minimum 4 weeks supplementation).
Measured: Individual participants will be followed for the duration of study enrollment, an expected average of 97 days. The study will remain open for up to 2 years or until subject number requirement is met.
Secondary outcomes (2)
Change in markers of plasma thiol status over the course of each time trial
- A) Plasma samples will be obtained before and during the final minute of each time trial. These samples will be stored at -80oC for no longer than 14 days to prevent sample deterioration.
- B) All samples will be analyzed for glutathione (GSH), oxidized glutathione (GSSG), cysteine (CySH), cystine (CySS), and cysteine-glutathione disulfide (CySSG) using high-performance liquid chromatography (Clinical Biomarkers Laboratory, Emory University, Atlanta, GA). Total glutathione (TGSH) will be calculated as GSH + 2•GSSG + CySSG. Total cysteine (TCyS) will be calculated as CySH + 2•CySS + CySSG.
Measured: Individual participants will be followed for the duration of study enrollment, an expected average of 97 days. The study will remain open for up to 2 years or until subject number requirement is met.
Outcome from specific questionnaires
- The Standardized Overtraining Questionnaire of The French Society for Sports Medicine (SFMS) B) Foster's Psychological Complaint Index C) Classification of Muscle Soreness
Measured: Individual participants will be followed for the duration of study enrollment, an expected average of 97 days. The study will remain open for up to 2 years or until subject number requirement is met.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2011 (estimated)
- Study startFeb 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- William Black
- Sponsor type
- University, hospital or other
- Collaborators
- Immunotec Inc.
- Responsible party
- Sponsor-investigator, William Black, University of Kentucky
- Investigators
- Michael Reid, Ph.D, Principal investigator, University of Kentucky, Dept of PhysiologyWilliam Black, MD, Principal investigator, University of Kentucky, Dept of Physiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01424904
- Sponsor's protocol ID
- 11-0626-F1V
- Status last verified
- Oct 2013
- First submitted
- 19 Aug 2011
- Last updated
- 18 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DGB-01 Effects on Endurance Exercise
- ClinicalTrials.gov ID
- NCT01424904
- Acronym / sponsor ID
- 11-0626-F1V
- Conditions
- Fatigue
- Keywords
- Ergogenic aid, Exercise endurance, High performance, Time trial performance, Glutathione
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- William BlackUniversity, hospital or other
- Collaborators
- Immunotec Inc.
- Study start
- Feb 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 29 Aug 2011 (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 purpose of this research is to evaluate the effects of DGB-01 on performance of a 40-km time trial in trained male cyclists. The investigators believe that DGB-01 will improve performance on the time trial as measured by a reduction in the amount of time required to complete the distance, using a computerized cycle ergometer.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DGB-01 | Experimental | Dietary Supplement: DGB-01 SupplementationAll subjects will receive DGB-01 during the study. Approximately one-half of the subjects during the first period and the other half during the second period. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy males who are trained cyclists with a maximal oxygen uptake relative to body weight equal to or greater than 45 ml O2/kg/min.
- Subjects must be in the competitive phase of their annual training cycle.
- Between ages of 18-60
- Availability- commitment of the subject/expected participation in the study for 97 days.
Key exclusion criteria (11 listed)
- Specific allergy to milk proteins (this is different from lactose intolerance)
- Use of immunosuppressive medication in the case of organ transplants
- Planned surgeries.
- Kidney disorders
- Use of antihypertensive medications
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 |
|---|---|---|
| DGB-01 SupplementationApproximately one-half of the subjects will initially receive DGB-01. The other half of the subjects will receive casein. Investigators and subjects are blinded to the product the subject is receiving. Subjects will be asked to consume one pouch of their assigned study product twice daily for four weeks. Subsequently, all subjects will undergo a supplement-free washout period of at least four weeks duration. Following the washout period, the subjects who originally received DGB-01 will receive casein and the subjects who originally received casein will receive DGB-01. Subjects will be asked to consume one pouch of their assigned study product twice daily for four weeks. | Dietary supplement | DGB-01 |
Primary outcome
The efficacy of DGB-01 in promoting exercise endurance will be measured by cycling performance on a standardized 40-km time trial course.
Time frame: Individual participants will be followed for the duration of study enrollment, an expected average of 97 days. The study will remain open for up to 2 years or until subject number requirement is met.
Time to complete the 40km time trial for subjects with DGB-01 intervention in period 1 (minimum 4 weeks of supplementation) versus the time for time trial completion of these subjects with casein in period 2 (minimum of 4 weeks of supplementation); Between the two periods with supplementation, there will be a washout period of a minimum 4 weeks; Results of time trial for subjects with DGB-01 intervention in period 2 (minimum 4 weeks of supplementation) versus the time trial completion of these subjects with casein in period 1 (minimum 4 weeks supplementation).
2 secondary outcomes
Change in markers of plasma thiol status over the course of each time trial
Time frame: Individual participants will be followed for the duration of study enrollment, an expected average of 97 days. The study will remain open for up to 2 years or until subject number requirement is met.
Outcome from specific questionnaires
Time frame: Individual participants will be followed for the duration of study enrollment, an expected average of 97 days. The study will remain open for up to 2 years or until subject number requirement is met.
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 18 Oct 2013.
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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.
Michael Reid, Ph.D principal investigator
University of Kentucky, Dept of Physiology
William Black, MD principal investigator
University of Kentucky, Dept of Physiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DGB-01 Supplementation in people with Fatigue, run by William Black at 1 site in United States.
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 4 inclusion and 11 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 18 Oct 2013. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
The efficacy of DGB-01 in promoting exercise endurance will be measured by cycling performance on a standardized 40-km time trial course. (time frame: Individual participants will be followed for the duration of study enrollment, an expected average of 97 days. The study will remain open for up to 2 years or until subject number requirement is met.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Oct 2013.