Effects of Lactobacillus Plantarum KABP-51 Probiotic on Body Composition, Microbiome and Mood in Healthy Overweight Adults
NCT ID: NCT06808061
Last Updated: 2025-02-05
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
60 participants
INTERVENTIONAL
2023-02-14
2023-10-15
Brief Summary
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Our subjects will be measured 4 times over the course of a 12-week supplementation period - at Baseline, Week 4, Week 8, and Week 12.
We will have 2 groups (N=30 per group):
* Probiotic Lactobacillus plantarum KABP-51
* Placebo (maltodextrin/corn starch) Subjects will be recruited from local fitness/wellness centers and businesses (e.g. Plymouth Fitness; Planet Fitness; Marathon Sports, etc) using a simple flyer.
If volunteers meet the inclusion/exclusion criteria, they will review/sign the Informed Consent Form (ICF) before any Baseline measurements are collected.
Participants will meet weekly (via online webinar) for educational sessions on nutrition, exercise, sleep, stress, and related healthy lifestyle topics. This periodic contact is extremely effective for maintaining compliance with the supplementation regimen and reducing dropouts.
Our expectation is that this fairly simple 12-week design will show that the KABP-51 probiotic strain can support a variety of psychological benefits such as reduced stress and improved mood; as well as physical benefits such as improved stress hormone exposure and microbiome balance - all of which may lead to improved body composition (lower body fat and improved muscle mass).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Probiotic
Lactobacillus plantarum KABP-51; 1-billion CFU
Lactobacillus plantarum
Lactobacillus plantarum KABP-51
Placebo
Maltodextrin
Placebo
maltodextrin
Interventions
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Lactobacillus plantarum
Lactobacillus plantarum KABP-51
Placebo
maltodextrin
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Inability to complete prescribed supplement regimen
* Current use of incompatible medications or supplements (weight loss, mood support, or blood sugar balance)
18 Years
65 Years
ALL
Yes
Sponsors
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Kaneka Americas Holding Inc.
INDUSTRY
3 Waves Wellness
INDUSTRY
Responsible Party
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Shawn Talbott
Scientist
Locations
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3Waves Wellness
Plymouth, Massachusetts, United States
Countries
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Other Identifiers
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KABPWeightMood2025
Identifier Type: -
Identifier Source: org_study_id
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