DGB-01 Effects on Endurance Exercise

William Black

Status: Completed

Conditions: Fatigue

Treatments: Dietary Supplement: DGB-01 Supplementation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01424904

11-0626-F1V

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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 days.

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Double Blind

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29 participants in 1 patient group

DGB-01

Experimental group

Description:

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.

Treatment:

Dietary Supplement: DGB-01 Supplementation