An interventional study of Probiotic and Placebo in Exercise Endurance, sponsored by Lallemand Health Solutions. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-02.
Sponsored by Lallemand Health Solutions · Not applicable, Interventional, and Basic science
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.
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.
Lallemand Health Solutions is the lead sponsor of 17 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Regularly participate in running and cross-training, and willing to maintain this level of training throughout the study. Participant must satisfy all three sub-criteria:
Exclusion Criteria:
Participants are randomized to receive probiotics for 6 weeks
Dietary Supplement: Probiotic
Participants are randomized to receive placebo for 6 weeks
Dietary Supplement: Placebo
Non-elite athletes receive probiotic for 6 weeks
Non-elite athletes receive placebo for 6 weeks
Time-to exhaustion during submaximal treadmill test
Comparison of time-to exhaustion during submaximal treadmill test at the end of intervention from those that received probiotic versus placebo.
Time frame: 6 weeks
Change in perceived exertion
Change from baseline in the Borg Rating of Perceived Exertion among probiotics versus placebo (score range = 9, very light effort to 20, extremely strenuous exercise)
Time frame: 6 weeks
Change in blood glucose
Change from baseline in capillary blood glucose among probiotics versus placebo
Time frame: 6 weeks
Change in blood lactate
Change from baseline in capillary blood lactate among probiotics versus placebo
Time frame: 6 weeks
Difference in salivary stress and immune biomarkers
To compare the difference in salivary cortisol, alpha-amylase and sIgA at the end of intervention among probiotics versus placebo
Time frame: 6 weeks
Difference in cold/flu episodes
To compare severity, duration and number of cold/flu episodes throughout the intervention among probiotics versus placebo, as assessed by a Visual Analogue Scale
Time frame: 6 weeks
Difference in gastrointestinal function and discomfort
To compare GI function during the intervention and change in GI function from baseline among probiotics versus placebo assessed by the Gastrointestinal Symptom Rating Scale (GSRS) and the Digestion-Associated Quality of Life (DQLQ).
Time frame: 6 weeks
Difference in bowel habits
To compare bowel habits during the intervention, frequency and consistency, among probiotics versus placebo assessed by the Bristol Stool Form Scale (BSFS)
Time frame: 6 weeks
Plan to share: No — After publications of the results, de-identified data will be shared with qualified researchers and scientists upon reasonable request to the sponsor including a detailed proposal of the intended use of the data, as per the Lallemand Health Solutions Inc. Policy on Clinical Trial Transparency and Data Sharing (available upon request).
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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