Clinical trial NCT04588142: Impact of Probiotic Supplementation on Exercise Endurance Among Non-elite Athletes
Official title: Impact of Probiotic Supplementation on Exercise Endurance Among Non-elite Athletes: A Randomized, Placebo-controlled, Double-blind, Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise Endurance
Keywords: Ergogenic effects
Probiotics
Non-elite athletes
Lead sponsor: Lallemand Health Solutions
Sponsor class: INDUSTRY
First posted: 2020-10-19
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time-to exhaustion during submaximal treadmill test
timeFrame: 6 weeks
Secondary outcomes:
measure: Change in perceived exertion
timeFrame: 6 weeks
measure: Change in blood glucose
timeFrame: 6 weeks
measure: Change in blood lactate
timeFrame: 6 weeks
measure: Difference in salivary stress and immune biomarkers
timeFrame: 6 weeks
measure: Difference in cold/flu episodes
timeFrame: 6 weeks
measure: Difference in gastrointestinal function and discomfort
timeFrame: 6 weeks
measure: Difference in bowel habits
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health Sports Performance Center
state: Florida
Study officials:
affiliation: University of Florida
name: Bobbi Langkamp-Henken, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.