Clinical trial NCT01424904: DGB-01 Effects on Endurance Exercise
Official title: DGB-01 Effects on Endurance Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Keywords: Ergogenic aid
Exercise endurance
High performance
Time trial performance
Glutathione
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: Immunotec Inc.
First posted: 2011-08-29
Enrollment: 29
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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 time trial as measured by a reduction in the amount of time required to complete the distance, using a computerized cycle ergometer.


Eligibility criteria: 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

Primary outcomes:
measure: The efficacy of DGB-01 in promoting exercise endurance will be measured by cycling performance on a standardized 40-km time trial course.
timeFrame: 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:
measure: Change in markers of plasma thiol status over the course of each time trial
timeFrame: 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.
measure: Outcome from specific questionnaires
timeFrame: 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.
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Center for Clinical and Translational Science
state: Kentucky
Study officials:
affiliation: University of Kentucky, Dept of Physiology
name: Michael Reid, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Kentucky, Dept of Physiology
name: William Black, MD
role: PRINCIPAL_INVESTIGATOR
References: