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DGB-01 Effects on Endurance Exercise

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ClinicalTrials.gov Identifier: NCT01424904
Recruitment Status : Completed
First Posted : August 29, 2011
Last Update Posted : October 18, 2013
Sponsor:
Collaborator:
Immunotec Inc.
Information provided by (Responsible Party):
William Black, University of Kentucky

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.

Condition or disease Intervention/treatment Phase
Fatigue Dietary Supplement: DGB-01 Supplementation Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: DGB-01 Effects on Endurance Exercise
Study Start Date : February 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 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.
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.




Primary Outcome Measures :
  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 Frame: 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. ]
    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).


Secondary Outcome Measures :
  1. Change in markers of plasma thiol status over the course of each time trial [ Time Frame: 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. ]
    • A) Plasma samples will be obtained before and during the final minute of each time trial. These samples will be stored at -80oC for no longer than 14 days to prevent sample deterioration.
    • B) All samples will be analyzed for glutathione (GSH), oxidized glutathione (GSSG), cysteine (CySH), cystine (CySS), and cysteine-glutathione disulfide (CySSG) using high-performance liquid chromatography (Clinical Biomarkers Laboratory, Emory University, Atlanta, GA). Total glutathione (TGSH) will be calculated as GSH + 2•GSSG + CySSG. Total cysteine (TCyS) will be calculated as CySH + 2•CySS + CySSG.

  2. Outcome from specific questionnaires [ Time Frame: 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. ]
    A) The Standardized Overtraining Questionnaire of The French Society for Sports Medicine (SFMS) B) Foster's Psychological Complaint Index C) Classification of Muscle Soreness



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01424904


Locations
United States, Kentucky
Center for Clinical and Translational Science
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
William Black
Immunotec Inc.
Investigators
Principal Investigator: Michael Reid, Ph.D University of Kentucky, Dept of Physiology
Principal Investigator: William Black, MD University of Kentucky, Dept of Physiology

Responsible Party: William Black, Sponsor/Investigator, University of Kentucky
ClinicalTrials.gov Identifier: NCT01424904     History of Changes
Other Study ID Numbers: 11-0626-F1V
First Posted: August 29, 2011    Key Record Dates
Last Update Posted: October 18, 2013
Last Verified: October 2013

Keywords provided by William Black, University of Kentucky:
Ergogenic aid
Exercise endurance
High performance
Time trial performance
Glutathione

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms