DGB-01 Effects on Endurance Exercise

NCT ID: NCT01424904

Last Updated: 2013-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2013-06-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

DGB-01

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.

Group Type: EXPERIMENTAL

DGB-01 Supplementation

Intervention Type: 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.

Interventions

DGB-01 Supplementation

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.

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Immunotec Inc.

INDUSTRY

Sponsor Role: collaborator

William Black

OTHER

Sponsor Role: lead

Responsible Party

William Black

Sponsor/Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Michael Reid, Ph.D

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky, Dept of Physiology

William Black, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky, Dept of Physiology

Locations

Center for Clinical and Translational Science

Lexington, Kentucky, United States

Countries

United States

Other Identifiers

11-0626-F1V

Identifier Type: -

Identifier Source: org_study_id