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

NCT06808061 | Completed

• 1 other identifier: KABPWeightMood2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Weight Loss; Mood

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Body Weight

  12 weeks

Secondary Outcomes (2)

• Microbiome Balance

  12 weeks

• Mood State

  12 weeks

Study Arms (2)

Probiotic

EXPERIMENTAL

Lactobacillus plantarum KABP-51; 1-billion CFU

Dietary Supplement: Lactobacillus plantarum

Placebo

PLACEBO COMPARATOR

Maltodextrin

Dietary Supplement: Placebo

Interventions

Lactobacillus plantarum DIETARY_SUPPLEMENT

Lactobacillus plantarum KABP-51

Probiotic

Placebo DIETARY_SUPPLEMENT

maltodextrin

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy moderately overweight

You may not qualify if:

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

Sponsors & Collaborators

• 3 Waves Wellness: lead
• Kaneka Americas Holding Inc.: collaborator

Study Sites (1)

3Waves Wellness

Plymouth, Massachusetts, 02360, United States

Location

MeSH Terms

Conditions

Weight Loss; Obesity; Depression; Dysbiosis

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Behavioral Symptoms; Behavior; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientist

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 5, 2025
• Study Start: February 14, 2023
• Primary Completion: July 15, 2023
• Study Completion: October 15, 2023
• Last Updated: February 5, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)