Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
17 participants
INTERVENTIONAL
2020-08-01
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
DOUBLE
Study Groups
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Probiotic treatment
P. acidilatici, CECT 7483, L. plantarum CECT 7484, L. plantarum CECT7485 in a ration of 1:1:1 at a dose of 3b cfu/day.
I3.1
Capsule containing bacterial strains Lactobacillus plantarum (CECT7484 and CECT7485) and Pediococcus acidilactici (CECT7483) at a ratio of 1:1:1.
Placebo treatment
Capsules indistinguishable from intervention containing maltodextrin.
Placebo treatment
Capsule containing maltodextrin.
Interventions
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I3.1
Capsule containing bacterial strains Lactobacillus plantarum (CECT7484 and CECT7485) and Pediococcus acidilactici (CECT7483) at a ratio of 1:1:1.
Placebo treatment
Capsule containing maltodextrin.
Eligibility Criteria
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Inclusion Criteria
* Healthy and injury free as determined by screening questions and medical history
* Distance runners as determined by physical activity questionnaire; run = 15 miles/week, run = 3 time or more/week
* VO2max level of = 40ml/kg/min for males or = 35ml/kg/min for females
* Agree to maintain normal diet and exercise routine throughout study
* Agrees to collect stool samples as needed
* Agree to complete questionnaires, records
Exclusion Criteria
* Subjects with a known allergy to the test material (active and placebo)
* Subjects taking NSAIDs, Metformin, probiotics, or supplements that might alter the gut microbiome;these will be assessed individually. (Multivitamin and protein supplementation are allowed)
* Subject that have abnormal test results during screening.
* Alcohol or drug abuse within past year (alcohol can impair gut barrier).
* History of GI surgery within past year as it would alter the gut microbiome (excluding appendectomy and herniorrhaphy).
* Severe heart, liver, kidney, neurological, oncological or psychiatric disease, or immunosuppressed subjects will be excluded.
* Coeliac disease, inflammatory bowel disease or acute pancreatitis (all 3 can impair gut barrier)
* Regular use of antacid medication (can significantly alter microbiota)
* Subject following a low FODMAP (fermentable oligo-, di-, mono-saccharides and polyols) diet will be excluded as this dietary pattern can alter the intestinal response to exercise in some people.
20 Years
50 Years
ALL
Yes
Sponsors
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University of Memphis
OTHER
Responsible Party
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Principal Investigators
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Marie van der Merwe, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Memphis
Locations
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University of Memphis
Memphis, Tennessee, United States
Countries
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Other Identifiers
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PRO-FY2020-304
Identifier Type: -
Identifier Source: org_study_id
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