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

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.

Study Overview

• Status: Completed
• Conditions: Exercise Endurance
• Intervention / Treatment: Dietary supplement: Probiotic; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32607
      • UF Health Sports Performance Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy adults between 18-45 years old

2. 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:

   1. 3-5 days per week of running or cross-training AND
   2. 45 minutes - 1.5 hours per activity session AND
   3. Run ≥15 miles per week
3. VO2 max values that in the 60-85th percentile (good-excellent health) range according to ACSM guidelines [1].

Exclusion Criteria:

1. Any physician-diagnosed diseases that would impact exercise performance or participation, including gastrointestinal disease, heart/cardiopulmonary disease, diabetes, thyroid disease, hypogonadism, hepatorenal disease, musculoskeletal disorder, neuromuscular/neurological disease, autoimmune disease, cancer, peptic ulcers or anemia.
2. Professional or elite athletes.
3. Use of any antibiotic drug within 4 weeks of randomization. Volunteer could be eligible to participate after a 2-week washout period.
4. Currently smoking (including vaping)
5. Pregnant, planning to get pregnant, or currently breastfeeding.
6. Lactose intolerance and/or milk, soy or yeast allergy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Participants are randomized to receive probiotics for 6 weeks	Dietary supplement: Probiotic; Non-elite athletes receive probiotic for 6 weeks
Placebo Comparator: Placebo group; Participants are randomized to receive placebo for 6 weeks	Dietary supplement: Placebo; Non-elite athletes receive placebo for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	6 weeks
Change in blood glucose	Change from baseline in capillary blood glucose among probiotics versus placebo	6 weeks
Change in blood lactate	Change from baseline in capillary blood lactate among probiotics versus placebo	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	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	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).	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)	6 weeks

Collaborators and Investigators

• Sponsor: Lallemand Health Solutions
• Investigators: Principal Investigator: Bobbi Langkamp-Henken, Ph.D., University of Florida

Publications and helpful links

General Publications

• McDermott CE, Vincent HK, Mathews AE, Cautela BG, Sandoval M, Tremblay A, Langkamp-Henken B. Impact of probiotic supplementation on exercise endurance among non-elite athletes: study protocol for a randomized, placebo-controlled, double-blind, clinical trial. Trials. 2022 Jul 27;23(1):603. doi: 10.1186/s13063-022-06552-x.

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2021
• Primary Completion (Actual): December 23, 2021
• Study Completion (Actual): December 23, 2021

Study Registration Dates

• First Submitted: October 1, 2020
• First Submitted That Met QC Criteria: October 8, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): September 19, 2022
• Last Update Submitted That Met QC Criteria: September 15, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Probiotics; Ergogenic effects; Non-elite athletes
• Other Study ID Numbers: L-020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: 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).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No