DGB-01 Effects on Endurance Exercise

Completed · Not applicable

Conditions studied: Fatigue

In brief

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.

Key facts

Study ID: NCT01424904
Run by: William Black
People needed: 29
Starts: 2012-02-01
Expected to finish: 2013-06-01
Last updated by the study team: 2013-10-18

Who can join

Age: 18 and older, up to 60. Sex: male. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

Center for Clinical and Translational Science — Lexington, Kentucky, United States

Full record on ClinicalTrials.gov

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