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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2023-11-30

Brief Summary

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This study is to evaluate the efficacy of a probiotic supplement on weight management and metabolic health. This study will be conducted as a hybrid trial consisting of both in-person visits and virtual assessments. Two groups will be included: the intervention (SlimBiotics Probiotic) and placebo.

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

Detailed Description

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Conditions

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Metabolic Health Weight Loss Stress Well-Being, Psychological Sleep Healthy Eating

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Trial. Participants will be randomized into the intervention group (SlimBiotics Probiotic) or into a placebo product control group.
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators
Both participant groups and the study coordinators will be blinded to the allocation.

Study Groups

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Intervention Group (SlimBiotic Probiotic)

Participants will take 1 serving (1 capsule) per day.

Group Type EXPERIMENTAL

Slimbiotic Probiotic

Intervention Type OTHER

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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.

Intervention Type OTHER

Placebo

The placebo capsule contains microcrystalline cellulose.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Women \& Men
* 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

* Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Citruslabs

INDUSTRY

Sponsor Role collaborator

Slimbiotics

UNKNOWN

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Citruslabs

Santa Monica, California, United States

Site Status

Countries

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United States

Other Identifiers

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20317

Identifier Type: -

Identifier Source: org_study_id

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