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

Stress Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of SlimBiotics Probiotic Formula on Weight Management and Metabolic Health Outcomes

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05917314
• Other study ID #: 20317
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: September 30, 2023

Study information

• Verified date: June 2023
• Source: Slimbiotics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: September 30, 2023
• Est. primary completion date: September 24, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Healthy Eating
• Metabolic Health
• Sleep
• Stress
• Weight Loss

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Citruslabs	Santa Monica	California

Sponsors (2)

Lead Sponsor	Collaborator
Slimbiotics	Citruslabs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Visceral Fat Mass (VFM) [Time Frame: Baseline to Week 12]	VFM will be measured as an assessment of weight management.	12 weeks
Primary	Change in Body Weight [Time Frame: Baseline to Week 12]	Body weight will be measured as an assessment of weight management.	12 weeks
Primary	Change in Waist Circumference. [Time Frame: Baseline to Week 12]	Waist circumference will be measured as an assessment of weight management.	12 weeks
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Changes in blood glucose. [Time Frame: Baseline to Week 12]	Blood glucose levels will be assessed via blood test.	12 weeks
Primary	Changes in blood insulin levels. [Time Frame: Baseline to Week 12]	Blood insulin levels will be assessed via blood test.	12 weeks
Primary	Changes in hbA1c. [Time Frame: Baseline to Week 12]	hbA1c will be assessed via blood test.	12 weeks
Primary	Changes in hs-high-sensitivity C-reactive protein (hsCRP). [Time Frame: Baseline to Week 12]	hsCRP will be assessed via blood test.	12 weeks
Primary	Changes in alanine transaminase. [Time Frame: Baseline to Week 12]	Alanine transaminase will be assessed via blood test.	12 weeks
Primary	Changes in aspartate aminotransferase. [Time Frame: Baseline to Week 12]	Aspartate aminotransferase will be assessed via blood test.	12 weeks
Primary	Changes in gamma-glutamyl transferase (GGT). [Time Frame: Baseline to Week 12]	GGT will be assessed via blood test.	12 weeks
Secondary	Changes in sleep duration. [Time Frame: Baseline to Week 12]	Changes in sleep duration will be assessed by the participants using their own smart device (e.g. sleep tracker, Apple Watch, FitBit etc)	12 weeks
Secondary	Changes in participants-perceived sleep quality. [Time Frame: Baseline to Week 12]	Changes in sleep quality will be assessed using study-specific surveys (0-5 scale).	12 weeks
Secondary	Changes in participant-reported mental wellbeing. [Time Frame: Baseline to Week 12]	Mental well-being will be assessed study-specific surveys (0-5 scale).	12 weeks
Secondary	Changes in scores on the Anxiety GAD7 Questionnaire [Time Frame: Baseline to Week 12]	Anxiety will be assessed using the validated Anxiety GAD7 Questionnaire (0-4 scale).	12 weeks
Secondary	Changes in health eating habits. [Time Frame: Baseline to Week 12]	Changes in healthy eating habits and satiety will be assessed using the standardised Three-Factor Eating Questionnaire (0-4 scale).	12 weeks