Back to resultsDGB-01 Effects on Endurance Exercise
Primary Purpose
Fatigue
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DGB-01 Supplementation
Sponsored by
About this trial
This is an interventional supportive care trial for Fatigue focused on measuring Ergogenic aid, Exercise endurance, High performance, Time trial performance, Glutathione
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
Sites / Locations
- Center for Clinical and Translational Science
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
DGB-01
Arm Description
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Change in markers of plasma thiol status over the course of each time trial
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.
Outcome from specific questionnaires
A) The Standardized Overtraining Questionnaire of The French Society for Sports Medicine (SFMS) B) Foster's Psychological Complaint Index C) Classification of Muscle Soreness
Full Information
NCT ID
NCT01424904
First Posted
August 19, 2011
Last Updated
October 17, 2013
Sponsor
William Black
Collaborators
Immunotec Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01424904
Brief Title
DGB-01 Effects on Endurance Exercise
Official Title
DGB-01 Effects on Endurance Exercise
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
William Black
Collaborators
Immunotec Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue
Keywords
Ergogenic aid, Exercise endurance, High performance, Time trial performance, Glutathione
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
N/A
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DGB-01
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
DGB-01 Supplementation
Intervention Description
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 Measure Information:
Title
The efficacy of DGB-01 in promoting exercise endurance will be measured by cycling performance on a standardized 40-km time trial course.
Description
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).
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.
Secondary Outcome Measure Information:
Title
Change in markers of plasma thiol status over the course of each time trial
Description
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.
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.
Title
Outcome from specific questionnaires
Description
A) The Standardized Overtraining Questionnaire of The French Society for Sports Medicine (SFMS) B) Foster's Psychological Complaint Index C) Classification of Muscle Soreness
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.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Reid, Ph.D
Organizational Affiliation
University of Kentucky, Dept of Physiology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William Black, MD
Organizational Affiliation
University of Kentucky, Dept of Physiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Clinical and Translational Science
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
12. IPD Sharing Statement
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DGB-01 Effects on Endurance Exercise
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