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| Name | Class |
|---|---|
| Kaneka Americas Holding Inc. | INDUSTRY |
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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):
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Experimental | Lactobacillus plantarum KABP-51; 1-billion CFU |
|
| Placebo | Placebo Comparator | Maltodextrin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus plantarum | Dietary Supplement | Lactobacillus plantarum KABP-51 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Body Weight | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Microbiome Balance | 12 weeks | |
| Mood State | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 3Waves Wellness | Plymouth | Massachusetts | 02360 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42065141 | Derived | Talbott S, Stephens B, Talbott J, Oddou M, Fumiki A. Effects of Lactiplantibacillus Plantarum KABP051 Probiotic on Body Composition, Microbiome and Mood in Healthy Overweight Adults. J Med Food. 2026 May 1:1096620X261448041. doi: 10.1177/1096620X261448041. Online ahead of print. |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D009765 | Obesity |
| D003863 | Depression |
| D064806 | Dysbiosis |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo |
| Dietary Supplement |
maltodextrin |
|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D010335 | Pathologic Processes |