DGB-01 Effects on Endurance Exercise

Not Applicable

Completed

• Conditions: Fatigue

• Registration Number: NCT01424904
• Lead Sponsor: William Black

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-19
• Study First Submitted QC: 2011-08-26
• Study First Posted: 2011-08-29
• Study Start: 2012-02
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-17
• Last Update Posted: 2013-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Name	Time	Method
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.	* 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	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

Trial Locations

Locations (1)

Center for Clinical and Translational Science; 🇺🇸 Lexington, Kentucky, United States