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OpenTrials
Completed

NCT Number: NCT06808061

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

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).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

3Waves Wellness

Plymouth, Massachusetts, 02360, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Lactobacillus plantarum

Dietary Supplement

Lactobacillus plantarum KABP-51

Placebo

Dietary Supplement

maltodextrin

Primary outcomes

  1. Body Weight

    Time frame: 12 weeks

Secondary outcomes

  1. Microbiome Balance

    Time frame: 12 weeks

  2. Mood State

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

3 Waves Wellness

Industry

Collaborators

  • Kaneka Americas Holding Inc.

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 5, 2025
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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