- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05917314
A Study to Evaluate the Effect of SlimBiotics Probiotic Formula on Weight Management and Metabolic Health Outcomes
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of SlimBiotics Probiotic Formula on Weight Management and Metabolic Health Outcomes
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
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Santa Monica, California, United States, 90404
- Citruslabs
-
Contact:
- Patrick Renner, MSc
- Phone Number: 424-245-0285
- Email: hello@citruslabs.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo Group
Participants will take 1 serving (1 capsule) per day.
|
The placebo capsule contains microcrystalline cellulose.
|
Experimental: Intervention Group (SlimBiotic Probiotic)
Participants will take 1 serving (1 capsule) per day.
|
SlimBiotics Probiotic formula contains three probiotic strains of L. fermentum:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Visceral Fat Mass (VFM) [Time Frame: Baseline to Week 12]
Time Frame: 12 weeks
|
VFM will be measured as an assessment of weight management.
|
12 weeks
|
Change in Body Weight [Time Frame: Baseline to Week 12]
Time Frame: 12 weeks
|
Body weight will be measured as an assessment of weight management.
|
12 weeks
|
Change in Waist Circumference. [Time Frame: Baseline to Week 12]
Time Frame: 12 weeks
|
Waist circumference will be measured as an assessment of weight management.
|
12 weeks
|
Change in blood pressure. [Time Frame: Baseline to Week 12]
Time Frame: 12 weeks
|
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]
Time Frame: 12 weeks
|
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]
Time Frame: 12 weeks
|
Survey based assessment (0-5 scale) of changes in metabolic health symptoms.
|
12 weeks
|
Changes in total cholesterol [Time Frame: Baseline to Week 12]
Time Frame: 12 weeks
|
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]
Time Frame: 12 weeks
|
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]
Time Frame: 12 weeks
|
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]
Time Frame: 12 weeks
|
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]
Time Frame: 12 weeks
|
Blood glucose levels will be assessed via blood test.
|
12 weeks
|
Changes in blood insulin levels. [Time Frame: Baseline to Week 12]
Time Frame: 12 weeks
|
Blood insulin levels will be assessed via blood test.
|
12 weeks
|
Changes in hbA1c. [Time Frame: Baseline to Week 12]
Time Frame: 12 weeks
|
hbA1c will be assessed via blood test.
|
12 weeks
|
Changes in hs-high-sensitivity C-reactive protein (hsCRP). [Time Frame: Baseline to Week 12]
Time Frame: 12 weeks
|
hsCRP will be assessed via blood test.
|
12 weeks
|
Changes in alanine transaminase. [Time Frame: Baseline to Week 12]
Time Frame: 12 weeks
|
Alanine transaminase will be assessed via blood test.
|
12 weeks
|
Changes in aspartate aminotransferase. [Time Frame: Baseline to Week 12]
Time Frame: 12 weeks
|
Aspartate aminotransferase will be assessed via blood test.
|
12 weeks
|
Changes in gamma-glutamyl transferase (GGT). [Time Frame: Baseline to Week 12]
Time Frame: 12 weeks
|
GGT will be assessed via blood test.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in participants-perceived sleep quality. [Time Frame: Baseline to Week 12]
Time Frame: 12 weeks
|
Changes in sleep quality will be assessed using study-specific surveys (0-5 scale).
|
12 weeks
|
Changes in participant-reported mental wellbeing. [Time Frame: Baseline to Week 12]
Time Frame: 12 weeks
|
Mental well-being will be assessed study-specific surveys (0-5 scale).
|
12 weeks
|
Changes in scores on the Anxiety GAD7 Questionnaire [Time Frame: Baseline to Week 12]
Time Frame: 12 weeks
|
Anxiety will be assessed using the validated Anxiety GAD7 Questionnaire (0-4 scale).
|
12 weeks
|
Changes in health eating habits. [Time Frame: Baseline to Week 12]
Time Frame: 12 weeks
|
Changes in healthy eating habits and satiety will be assessed using the standardised Three-Factor Eating Questionnaire (0-4 scale).
|
12 weeks
|
Changes in sleep duration. [Time Frame: Baseline to Week 12]
Time Frame: 12 weeks
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20317
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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