Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04588142 |
Other study ID # |
L-020 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
March 12, 2021 |
Est. completion date |
December 23, 2021 |
Study information
Verified date |
February 2023 |
Source |
Lallemand Health Solutions |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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 MiniĀ®, 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 MiniĀ® 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.