Clinical trial NCT05917314: A Study to Evaluate the Effect of SlimBiotics Probiotic Formula on Weight Management and Metabolic Health Outcomes
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of SlimBiotics Probiotic Formula on Weight Management and Metabolic Health Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Health
Weight Loss
Stress
Well-Being, Psychological
Sleep
Healthy Eating
Lead sponsor: SlimBiotics Inc.
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2023-06-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial. Participants will be randomized into the intervention group (SlimBiotics Probiotic) or into a placebo product control group.
Primary purpose: OTHER

Brief summary: 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


Eligibility criteria: 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.)

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
* Any disease or condition which might compromise significantly the hepatic (ascites), hematopoietic, renal, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system with the exception of the conditions defined by the inclusion criteria
* 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

Primary outcomes:
measure: Change in Visceral Fat Mass (VFM) [Time Frame: Baseline to Week 12]
timeFrame: 12 weeks
measure: Change in Body Weight [Time Frame: Baseline to Week 12]
timeFrame: 12 weeks
measure: Change in Waist Circumference. [Time Frame: Baseline to Week 12]
timeFrame: 12 weeks
measure: Change in blood pressure. [Time Frame: Baseline to Week 12]
timeFrame: 12 weeks
measure: Change in resting heart rate. [Time Frame: Baseline to Week 12]
timeFrame: 12 weeks
measure: Changes in metabolic health symptoms. [Time Frame: Baseline to Week 12]
timeFrame: 12 weeks
measure: Changes in total cholesterol [Time Frame: Baseline to Week 12]
timeFrame: 12 weeks
measure: Changes in blood levels of triglycerides. [Time Frame: Baseline to Week 12]
timeFrame: 12 weeks
measure: Changes in blood levels of high-density lipoprotein. [Time Frame: Baseline to Week 12]
timeFrame: 12 weeks
measure: Changes in blood levels of low-density lipoprotein. [Time Frame: Baseline to Week 12]
timeFrame: 12 weeks
measure: Changes in blood glucose. [Time Frame: Baseline to Week 12]
timeFrame: 12 weeks
measure: Changes in blood insulin levels. [Time Frame: Baseline to Week 12]
timeFrame: 12 weeks
measure: Changes in hbA1c. [Time Frame: Baseline to Week 12]
timeFrame: 12 weeks
measure: Changes in hs-high-sensitivity C-reactive protein (hsCRP). [Time Frame: Baseline to Week 12]
timeFrame: 12 weeks
measure: Changes in alanine transaminase. [Time Frame: Baseline to Week 12]
timeFrame: 12 weeks
measure: Changes in aspartate aminotransferase. [Time Frame: Baseline to Week 12]
timeFrame: 12 weeks
measure: Changes in gamma-glutamyl transferase (GGT). [Time Frame: Baseline to Week 12]
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes in sleep duration. [Time Frame: Baseline to Week 12]
timeFrame: 12 weeks
measure: Changes in participants-perceived sleep quality. [Time Frame: Baseline to Week 12]
timeFrame: 12 weeks
measure: Changes in participant-reported mental wellbeing. [Time Frame: Baseline to Week 12]
timeFrame: 12 weeks
measure: Changes in scores on the Anxiety GAD7 Questionnaire [Time Frame: Baseline to Week 12]
timeFrame: 12 weeks
measure: Changes in health eating habits. [Time Frame: Baseline to Week 12]
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References: