Impact of Probiotic Supplementation on Exercise Endurance Among Non-elite Athletes
Condition: Exercise Endurance
Study type: Interventional

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.
    

Intervention name(s): Probiotic; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Non-elite athletes receive probiotic for 6 weeks; Non-elite athletes receive placebo for 6 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Ergogenic effects; Probiotics; Non-elite athletes