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

  • STATUS
    Recruiting
  • End date
    Jun 8, 2022
  • participants needed
    32
  • sponsor
    Lallemand Health Solutions
Updated on 8 September 2021

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.

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.

Details
Condition Exercise Endurance
Treatment Placebo, Probiotic
Clinical Study IdentifierNCT04588142
SponsorLallemand Health Solutions
Last Modified on8 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Healthy adults between 18-45 years old
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
3-5 days per week of running or cross-training AND
45 minutes - 1.5 hours per activity session AND
Run 15 miles per week
VO2 max values that in the 60-85th percentile (good-excellent health) range according to ACSM guidelines [1]

Exclusion Criteria

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
Professional or elite athletes
Use of any antibiotic drug within 4 weeks of randomization. Volunteer could be eligible to participate after a 2-week washout period
Currently smoking (including vaping)
Pregnant, planning to get pregnant, or currently breastfeeding
Lactose intolerance and/or milk, soy or yeast allergy
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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