DGB-01 Effects on Endurance Exercise

Fatigue Clinical Trial

Official title:

DGB-01 Effects on Endurance Exercise

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01424904
• Other study ID #: 11-0626-F1V
• Status: Completed
• Phase: N/A
• First received: August 19, 2011
• Last updated: October 17, 2013
• Start date: February 2012
• Est. completion date: June 2013

Study information

• Verified date: October 2013
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Fatigue

Intervention

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.

Locations

Country	Name	City	State
United States	Center for Clinical and Translational Science	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
William Black	Immunotec Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	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.	No
Secondary	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.	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.	No
Secondary	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	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.	No