A Study to Evaluate the Effect of SlimBiotics Probiotic Formula on Weight Management and Metabolic Health Outcomes
NCT ID: NCT05917314
Last Updated: 2024-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2023-07-01
2023-11-30
Brief Summary
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The SlimBiotics probiotic formula is the first plant-based probiotic targeting weight management and metabolic health. Other competing probiotics are isolated from humans (feces) but the strains in SlimBiotics were isolated from a fermented plant (millet porridge cereal).
This product contains 3 probiotic strains:
Limosilactobacillus fermentum K7-Lb1 Limosilactobacillus fermentum K8-Lb1 Limosilactobacillus fermentum K11-Lb3
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Intervention Group (SlimBiotic Probiotic)
Participants will take 1 serving (1 capsule) per day.
Slimbiotic Probiotic
SlimBiotics Probiotic formula contains three probiotic strains of L. fermentum:
* Limosilactobacillus fermentum K7-Lb1
* Limosilactobacillus fermentum K8-Lb1
* Limosilactobacillus fermentum K11-Lb3 The product also contains Microcrystalline cellulose.
Placebo Group
Participants will take 1 serving (1 capsule) per day.
Placebo
The placebo capsule contains microcrystalline cellulose.
Interventions
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Slimbiotic Probiotic
SlimBiotics Probiotic formula contains three probiotic strains of L. fermentum:
* Limosilactobacillus fermentum K7-Lb1
* Limosilactobacillus fermentum K8-Lb1
* Limosilactobacillus fermentum K11-Lb3 The product also contains Microcrystalline cellulose.
Placebo
The placebo capsule contains microcrystalline cellulose.
Eligibility Criteria
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Inclusion Criteria
* 18+
* BMI between 25-32
* Generally healthy - don't live with any uncontrolled chronic disease
* Own a sleep-tracking device (smart watch etc.)
* History of or present liver deficiency as defined by Quick \< 70%
* Regular medical treatment including over-the-counter, which may have an impact on the study aims (e.g. probiotics containing supplements, laxatives, steroids etc.)
* History of hepatitis B, C, HIV
* Subjects who are scheduled to undergo any diagnostic intervention or hospitalization which may cause protocol deviations
* Simultaneous study participation by members of the same household
* Pregnancy and lactation
* Ascites as assessed by sonography
* Any diet to lose body weight
* Eating disorders or vegan diet
* Anorexia drugs
* Present drug abuse or alcoholism
Exclusion Criteria
* Anyone with known severe allergic reactions.
* Women who are pregnant, breastfeeding or attempting to become pregnant
* Unwilling to follow the study protocol.
* Subjects currently enrolled in another clinical study
* Subjects having finished another clinical study within the last 4 weeks before inclusion
* Hypersensitivity, allergy or intolerance against any compound of the test products (e. g. acacia gum)
* Condition after implantation of a cardiac pacemaker or other active implants
* Sulfonylurea treatment
18 Years
ALL
Yes
Sponsors
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Citruslabs
INDUSTRY
Slimbiotics
UNKNOWN
Responsible Party
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Locations
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Citruslabs
Santa Monica, California, United States
Countries
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Other Identifiers
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20317
Identifier Type: -
Identifier Source: org_study_id
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