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Effects of Lactobacillus Plantarum KABP-51 Probiotic on Body Composition, Microbiome and Mood in Healthy Overweight Adults

Effects of Kaneka KABP-51 Probiotic on Mood, Metabolism, Microbiome, and Body Composition in Healthy Adults

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06808061
Enrollment
60
Registered
2025-02-05
Start date
2023-02-14
Completion date
2023-10-15
Last updated
2025-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mood, Weight Loss

Keywords

microbiome, probiotic, psychobiotic, weight loss, body composition, obesity, depression, dysbiosis

Brief summary

The objective of this study is to recruit 60 healthy moderately overweight subjects to participate in a research study investigating the effects of a specific probiotic strain (Lactobacillus plantarum KABP-51) on measures of psychological mood state, gut microbiome status, stress hormones, and body composition (body fat and muscle mass). 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).

Interventions

DIETARY_SUPPLEMENTLactobacillus plantarum

Lactobacillus plantarum KABP-51

DIETARY_SUPPLEMENTPlacebo

maltodextrin

Sponsors

Kaneka Americas Holding Inc.
CollaboratorINDUSTRY
3 Waves Wellness
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* healthy moderately overweight

Exclusion criteria

* Pregnant women * Inability to complete prescribed supplement regimen * Current use of incompatible medications or supplements (weight loss, mood support, or blood sugar balance)

Design outcomes

Primary

MeasureTime frame
Body Weight12 weeks

Secondary

MeasureTime frame
Microbiome Balance12 weeks
Mood State12 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 2, 2026