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

NCT04588142 | Completed

• 1 other identifier: L-020
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Exercise Endurance

Keywords

Ergogenic effects; Probiotics; Non-elite athletes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change in perceived exertion

  6 weeks

• Change in blood glucose

  6 weeks

• Change in blood lactate

  6 weeks

• Difference in salivary stress and immune biomarkers

  6 weeks

• Difference in cold/flu episodes

  6 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

Participants are randomized to receive probiotics for 6 weeks

Dietary Supplement: Probiotic

Placebo group

PLACEBO COMPARATOR

Participants are randomized to receive placebo for 6 weeks

Dietary Supplement: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

Non-elite athletes receive probiotic for 6 weeks

Experimental group

Placebo DIETARY_SUPPLEMENT

Non-elite athletes receive placebo for 6 weeks

Placebo group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• days per week of running or cross-training AND
• 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 \[1\].

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lallemand Health Solutions: lead

Study Sites (1)

UF Health Sports Performance Center

Gainesville, Florida, 32607, United States

Location

Related Publications (1)

• 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.

  PMID: 35897037 DERIVED

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Bobbi Langkamp-Henken, Ph.D.

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2020
• First Posted: October 19, 2020
• Study Start: March 12, 2021
• Primary Completion: December 23, 2021
• Study Completion: December 23, 2021
• Last Updated: February 2, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)