A Study to Evaluate the Effect of SlimBiotics Probiotic Formula on Weight Management and Metabolic Health Outcomes

NCT05917314 | Completed

• 1 other identifier: 20317
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (17)

• Change in Visceral Fat Mass (VFM) [Time Frame: Baseline to Week 12]

  VFM will be measured as an assessment of weight management.

  12 weeks

• Change in Body Weight [Time Frame: Baseline to Week 12]

  Body weight will be measured as an assessment of weight management.

  12 weeks

• Change in Waist Circumference. [Time Frame: Baseline to Week 12]

  Waist circumference will be measured as an assessment of weight management.

  12 weeks

• Change in blood pressure. [Time Frame: Baseline to Week 12]

  Blood pressure will be measured as a marker of metabolic health. Both both systolic and diastolic blood pressure will be measured.

  12 weeks

• Change in resting heart rate. [Time Frame: Baseline to Week 12]

  Resting heart rate will be measured as a marker of metabolic health.

  12 weeks

• Changes in metabolic health symptoms. [Time Frame: Baseline to Week 12]

  Survey based assessment (0-5 scale) of changes in metabolic health symptoms.

  12 weeks

• Changes in total cholesterol [Time Frame: Baseline to Week 12]

  Total cholesterol will be assessed as part of a lipid panel blood test.

  12 weeks

• Changes in blood levels of triglycerides. [Time Frame: Baseline to Week 12]

  Triglycerides will be assessed as part of a lipid panel blood test.

  12 weeks

• Changes in blood levels of high-density lipoprotein. [Time Frame: Baseline to Week 12]

  Blood levels of high-density lipoprotein will be assessed as part of a lipid panel blood test.

  12 weeks

• Changes in blood levels of low-density lipoprotein. [Time Frame: Baseline to Week 12]

  Blood levels of low-density lipoprotein will be assessed as part of a lipid panel blood test.

  12 weeks

• Changes in blood glucose. [Time Frame: Baseline to Week 12]

  Blood glucose levels will be assessed via blood test.

  12 weeks

• Changes in blood insulin levels. [Time Frame: Baseline to Week 12]

  Blood insulin levels will be assessed via blood test.

  12 weeks

• Changes in hbA1c. [Time Frame: Baseline to Week 12]

  hbA1c will be assessed via blood test.

  12 weeks

• Changes in hs-high-sensitivity C-reactive protein (hsCRP). [Time Frame: Baseline to Week 12]

  hsCRP will be assessed via blood test.

  12 weeks

• Changes in alanine transaminase. [Time Frame: Baseline to Week 12]

  Alanine transaminase will be assessed via blood test.

  12 weeks

• Changes in aspartate aminotransferase. [Time Frame: Baseline to Week 12]

  Aspartate aminotransferase will be assessed via blood test.

  12 weeks

• Changes in gamma-glutamyl transferase (GGT). [Time Frame: Baseline to Week 12]

  GGT will be assessed via blood test.

  12 weeks

Secondary Outcomes (5)

• Changes in sleep duration. [Time Frame: Baseline to Week 12]

  12 weeks

• Changes in participants-perceived sleep quality. [Time Frame: Baseline to Week 12]

  12 weeks

• Changes in participant-reported mental wellbeing. [Time Frame: Baseline to Week 12]

  12 weeks

• Changes in scores on the Anxiety GAD7 Questionnaire [Time Frame: Baseline to Week 12]

  12 weeks

• Changes in health eating habits. [Time Frame: Baseline to Week 12]

  12 weeks

Study Arms (2)

Intervention Group (SlimBiotic Probiotic)

EXPERIMENTAL

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

Other: Slimbiotic Probiotic

Placebo Group

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Slimbiotic Probiotic 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.

Intervention Group (SlimBiotic Probiotic)

Placebo OTHER

The placebo capsule contains microcrystalline cellulose.

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women \& Men
• BMI between 25-32
• Generally healthy - don't live with any uncontrolled chronic disease
• Own a sleep-tracking device (smart watch etc.)

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Slimbiotics: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Weight Loss; Psychological Well-Being

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Personal Satisfaction; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Both participant groups and the study coordinators will be blinded to the allocation.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: UNKNOWN
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial. Participants will be randomized into the intervention group (SlimBiotics Probiotic) or into a placebo product control group.

Study Record Dates

• First Submitted: June 1, 2023
• First Posted: June 23, 2023
• Study Start: July 1, 2023
• Primary Completion: November 24, 2023
• Study Completion: November 30, 2023
• Last Updated: August 23, 2024

Record last verified: 2024-08

Locations

US (1)