DGB-01 Effects on Endurance Exercise

Conditions:Other Indications
Therapuetic Areas:Other
Age Range:18 - 60
Start Date:February 2012
Contact:William Black, MD
Phone:(859) 218-3276

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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.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

- All medications that can interfere with muscle mass such as corticosteroids (e.g.
prednisone), testosterone replacement or anabolic drugs such as Megace
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Lexington, KY
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