Impact of probiotic supplementation on exercise endurance among non-elite athletes: study protocol for a randomized, placebo-controlled, double-blind, clinical trial

Abstract

Background: Some probiotics appear to improve athletic performance, endurance, and recovery after intense exercise. Other formulations may provide performance-related benefits via immune and gastrointestinal functions in athletic individuals. However, few formulations have been studied for both types of effects among non-elite athletes. The primary objective of this study is to assess the ergogenic effects of a probiotic on high-intensity endurance running performance in non-elite runners. Secondary objectives include assessment of perceived exertion, blood chemistry, immune and stress biomarkers, cold and flu symptoms, and gastrointestinal health after the probiotic intervention.

Methods: This 9-week randomized, placebo-controlled, double-blind, parallel trial will assess the ergogenic effects of a probiotic (5 billion colony-forming units/day, for 6 weeks) in healthy, non-elite runners (N=32; 18-45 years). Participants will be monitored via daily and weekly questionnaires during the 2-week pre-baseline, 6-week intervention, and 1-week washout. Questionnaires will inquire about activity, muscle soreness, gastrointestinal symptoms, cold and flu symptoms, stool form and frequency, and adverse events. During the pre-baseline visit, maximal oxygen uptake (V̇O2 max) is assessed to set appropriate individualized workload settings for the treadmill time-to-exhaustion endurance tests. These time-to-exhaustion endurance running tests will be completed at an intensity of 85% VO2max at baseline and final visits. During these tests, self-perceived exercise effort will be rated via the Borg Rating of Perceived Exertion scale and finger sticks assessing capillary blood glucose and lactate concentrations will be collected every 3 min. Additional questionnaires will assess diet and motivation to exercise. Body composition will be assessed using air displacement plethysmography at the baseline and final visits. Hypotheses will be tested using two-sided tests, and a linear model and with a type I error rate of α=0.05. Primary and secondary outcomes will be tested by comparing results between the intervention groups, adjusting for baseline values.

Discussion: These results will build evidence documenting the role of probiotics on running endurance performance and physiological responses to exercise in non-elite athletes. Understanding the potential mechanisms of probiotic effects and how they mitigate the intestinal or immune discomforts caused by running could provide additional strategy means to help runners improve their performance.

Trial registration number: ClinicalTrials.gov NCT04588142 . Posted on October 19, 2020.

Protocol version: July 2, 2021, version 1.2.

Keywords: Ergogenic; Non-elite athletes; Performance; Probiotics; Running.

Conflict of interest statement

BGC and MS were employed by the study sponsor, Lallemand Health Solutions Inc, 6100 Royalmount Avenue, Montreal, QC, Canada, H4P 2R2, a company that researches, manufactures, and sells probiotics to businesses but not to consumers. CEM, HKV, AEM, and BLH have no competing interests to declare.

© 2022. The Author(s).

Figures

Fig. 1

Study process diagram. AE, adverse events; BREQ-3, Behavioral Regulation in Exercise Questionnaire; BRPE, Borg Rating Perceived Exertion scale; sHEI, Short Healthy Eating Index; sIgA, secretory immunoglobulin A; VO2max, maximal rate of oxygen consumption

Fig. 2

Treadmill endurance running test protocol for visits 3 (baseline) and 4 (final, 6 weeks post-intervention)