Status:
COMPLETED
DGB-01 Effects on Endurance Exercise
Lead Sponsor:
William Black
Collaborating Sponsors:
Immunotec Inc.
Conditions:
Fatigue
Eligibility:
MALE
18-60 years
Phase:
NA
Brief 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 t...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT01424904
Start Date
February 1 2012
End Date
June 1 2013
Last Update
October 18 2013
Active Locations (1)
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1
Center for Clinical and Translational Science
Lexington, Kentucky, United States, 40536