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NCT06808061 · ClinicalTrials.gov registry record · NA
Effects of Lactobacillus Plantarum KABP-51 Probiotic on Body Composition, Microbiome and Mood in Healthy Overweight Adults
A NA study of Weight Loss and Mood, sponsored by 3 Waves Wellness.
- Completed
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT06808061 is a NA study of Weight Loss and Mood that has completed, run by 3 Waves Wellness. The registered enrollment target is 60 participants, below the 1,501-participant average among 116 other Weight Loss trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06808061, a NA study of Weight Loss and Mood, has completed, sponsored by 3 Waves Wellness.
- COMPLETED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT Lactobacillus plantarum
Study Locations (1)
Massachusetts
- 3Waves Wellness - Plymouth
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2023-02-14 |
| Est. Completion | 2023-10-15 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06808061
The ClinicalTrials.gov registry entry for NCT06808061 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,501-participant average among 116 other Weight Loss trials with a reported enrollment target (96% lower). The listed sponsor is 3 Waves Wellness, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Weight Loss appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06808061 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06808061 about?
NCT06808061 is a clinical study titled "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 ...
What is the current status of trial NCT06808061?
This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2023-02-14. Estimated completion is 2023-10-15.
What conditions does trial NCT06808061 study?
This clinical trial studies the following conditions: Weight Loss, Mood.
What interventions are being tested in trial NCT06808061?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), Lactobacillus plantarum (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT06808061?
This trial is sponsored by 3 Waves Wellness, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06808061 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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