NCT04588142

Impact of Probiotic Supplementation on Exercise Endurance Among Non-elite Athletes

Impact of Probiotic Supplementation on Exercise Endurance Among Non-elite Athletes: A Randomized, Placebo-controlled, Double-blind, Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Lallemand Health Solutions · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The aim of this trial is to evaluate the effects of 6-week administration of probiotics on running performance among non-elite athletes. It is hypothesized that participants receiving probiotics may improve their running performance at an endurance test compared to their placebo-receiving counterparts.

Detailed description

Participants recruited from the university community in the Southeast U.S. will participate in a randomized, double-blind, placebo-controlled interventional study for approximately 9 weeks following obtainment of informed consent. Two weeks prior to randomization participants will begin the pre-baseline period and complete daily and weekly questionnaires (physical activity and muscle soreness, bowel movements and gastrointestinal health, flu and cold symptoms). Visit 2 will occur during the pre-baseline period and participants will complete a VO2 max fitness assessment, which will be used during the endurance testing. Participants will also receive the SenseWear Armdand Mini®, a wearable device that will record their physical activity, sleeping patterns and energy expenditure for one week prior to visits 3 and 4. Participants will be randomized at visit 3. Prior to this visit, participants will consume a standardized breakfast, collect a stool sample and a saliva sample that will be brought to site. During this visit participants will have a body composition and perform the Submaximal Treadmill Test. During the treadmill test, participants will provide finger prick samples for subsequent analysis of blood metabolites (glucose and lactate) and perceived exhaustion subjectively. Lastly, participants will complete several nutrition and motivation-related questionnaires. One week prior to the final visit (V4), participants will be asked to wear the SenseWear Armband Mini® again for one week, which they will return at the final visit. Participants will eat another standardized breakfast prior to the final visit, visit 4. They will bring a stool and saliva sample to the site. During visit 4, participants will complete the submaximal treadmill test, while providing finger prick samples for analysis of blood and lactate levels. In addition, body composition will be assessed, as well as nutrition and motivation (subjectively). Visit 4 will be followed by a washout week, during which participants will not intake the study supplement but they will complete daily, weekly, and the final questionnaire.

Conditions

• Exercise Endurance

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic	Non-elite athletes receive probiotic for 6 weeks
DIETARY_SUPPLEMENT	Placebo	Non-elite athletes receive placebo for 6 weeks

Timeline

• Start date: 2021-03-12
• Primary completion: 2021-12-23
• Completion: 2021-12-23
• First posted: 2020-10-19
• Last updated: 2023-02-02

Locations

1 site across 1 country: United States