DGB-01 Effects on Endurance Exercise

NCT01424904 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2013-10-18

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

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.

Sponsors & Collaborators

  • Immunotec Inc.

    collaborator INDUSTRY
  • William Black

    lead OTHER

Principal Investigators

  • Michael Reid, Ph.D · University of Kentucky, Dept of Physiology

  • William Black, MD · University of Kentucky, Dept of Physiology

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01424904 on ClinicalTrials.gov