DGB-01 Effects on Endurance Exercise

NCT01424904 | Completed

• 1 other identifier: 11-0626-F1V
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Fatigue

Keywords

Ergogenic aid; Exercise endurance; High performance; Time trial performance; Glutathione

Outcome Measures

Primary Outcomes (1)

• The efficacy of DGB-01 in promoting exercise endurance will be measured by cycling performance on a standardized 40-km time trial course.

  Time to complete the 40km time trial for subjects with DGB-01 intervention in period 1 (minimum 4 weeks of supplementation) versus the time for time trial completion of these subjects with casein in period 2 (minimum of 4 weeks of supplementation); Between the two periods with supplementation, there will be a washout period of a minimum 4 weeks; Results of time trial for subjects with DGB-01 intervention in period 2 (minimum 4 weeks of supplementation) versus the time trial completion of these subjects with casein in period 1 (minimum 4 weeks supplementation).

  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 (2)

• Change in markers of plasma thiol status over the course of each time trial

  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.

• Outcome from specific questionnaires

  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.

Study Arms (1)

DGB-01

EXPERIMENTAL

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.

Dietary Supplement: DGB-01 Supplementation

Interventions

DGB-01 Supplementation DIETARY_SUPPLEMENT

Approximately one-half of the subjects will initially receive DGB-01. The other half of the subjects will receive casein. Investigators and subjects are blinded to the product the subject is receiving. Subjects will be asked to consume one pouch of their assigned study product twice daily for four weeks. Subsequently, all subjects will undergo a supplement-free washout period of at least four weeks duration. Following the washout period, the subjects who originally received DGB-01 will receive casein and the subjects who originally received casein will receive DGB-01. Subjects will be asked to consume one pouch of their assigned study product twice daily for four weeks.

DGB-01

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• William Black: lead
• Immunotec Inc.: collaborator

Study Sites (1)

Center for Clinical and Translational Science

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Reid, Ph.D

  University of Kentucky, Dept of Physiology

  PRINCIPAL INVESTIGATOR

• William Black, MD

  University of Kentucky, Dept of Physiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor/Investigator

Study Record Dates

• First Submitted: August 19, 2011
• First Posted: August 29, 2011
• Study Start: February 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: October 18, 2013

Record last verified: 2013-10

Locations

US (1)