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A Study to Evaluate the Effect of SlimBiotics L. Fermentum K8 Postbiotic on Weight Management and Metabolic Health Outcomes

Primary Purpose

Metabolic Health, Weight Loss, Stress

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Slimbiotics Postbiotic
Placebo
Sponsored by
Slimbiotics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Metabolic Health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Women & Men 18+ BMI between 25-32 (average BMI of subjects shall not exceed 30) 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 significantly compromise 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

Sites / Locations

  • Citruslabs

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention Group (SlimBiotic Postbiotic)

Placebo Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in Visceral Fat Mass (VFM) [Time Frame: Baseline to Week 12]
VFM will be measured as an assessment of weight management.
Change in Body Weight [Time Frame: Baseline to Week 12]
Body weight will be measured as an assessment of weight management.
Change in Waist Circumference. [Time Frame: Baseline to Week 12]
Waist circumference will be measured as an assessment of weight management.
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.
Change in resting heart rate. [Time Frame: Baseline to Week 12]
Resting heart rate will be measured as a marker of metabolic health.
Changes in metabolic health symptoms. [Time Frame: Baseline to Week 12]
Survey based assessment (0-5 scale) of changes in metabolic health symptoms.
Changes in total cholesterol [Time Frame: Baseline to Week 12]
Total cholesterol will be assessed as part of a lipid panel blood test.
Changes in blood levels of triglycerides. [Time Frame: Baseline to Week 12]
Triglycerides will be assessed as part of a lipid panel blood test.
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.
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.
Changes in blood glucose. [Time Frame: Baseline to Week 12]
Blood glucose levels will be assessed via blood test.
Changes in blood insulin levels. [Time Frame: Baseline to Week 12]
Blood insulin levels will be assessed via blood test.
Changes in hbA1c. [Time Frame: Baseline to Week 12]
hbA1c will be assessed via blood test.
Changes in hs-high-sensitivity C-reactive protein (hsCRP). [Time Frame: Baseline to Week 12]
hsCRP will be assessed via blood test.
Changes in alanine transaminase. [Time Frame: Baseline to Week 12]
Alanine transaminase will be assessed via blood test.
Changes in aspartate aminotransferase. [Time Frame: Baseline to Week 12]
Aspartate aminotransferase will be assessed via blood test.
Changes in gamma-glutamyl transferase (GGT). [Time Frame: Baseline to Week 12]
GGT will be assessed via blood test.

Secondary Outcome Measures

Changes in sleep duration. [Time Frame: Baseline to Week 12]
Changes in sleep will be assessed by the participants using their own smart device (e.g. sleep tracker, Apple Watch, FitBit etc)
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).
Changes in participant-reported mental wellbeing. [Time Frame: Baseline to Week 12]
Mental well-being will be assessed study-specific surveys (0-5 scale).
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).
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).

Full Information

First Posted
June 1, 2023
Last Updated
June 10, 2023
Sponsor
Slimbiotics
Collaborators
Citruslabs
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1. Study Identification

Unique Protocol Identification Number
NCT05912699
Brief Title
A Study to Evaluate the Effect of SlimBiotics L. Fermentum K8 Postbiotic on Weight Management and Metabolic Health Outcomes
Official Title
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of SlimBiotics L. Fermentum K8 Postbiotic on Weight Management and Metabolic Health Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
September 23, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Slimbiotics
Collaborators
Citruslabs

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is to evaluate the efficacy of a postbiotic 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 postbiotic) and placebo. The SlimBiotics postbiotic formula is the first plant-based postbiotic targeting weight management and metabolic health. Other competing postbiotics are isolated from humans (feces) but the strains in SlimBiotics were isolated from a fermented plant (millet porridge cereal) This product contains L. fermentum K8 Postbiotic.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Health, Weight Loss, Stress, Well-Being, Psychological, Sleep, Healthy Eating

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial. Participants will be randomized into the intervention group (SlimBiotics Postbiotic) or into a placebo product control group
Masking
ParticipantInvestigator
Masking Description
Both participant groups and the study coordinators will be blinded to the allocation.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group (SlimBiotic Postbiotic)
Arm Type
Experimental
Arm Description
Participants will take 1 serving (1 capsule) per day.
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Participants will take 1 serving (1 capsule) per day.
Intervention Type
Other
Intervention Name(s)
Slimbiotics Postbiotic
Intervention Description
SlimBiotics postbiotic formula contains the following ingredients: Heat-inactivated L. fermentum K8 Postbiotic. Microcrystalline cellulose.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
The placebo capsules contain microcrystalline cellulose only.
Primary Outcome Measure Information:
Title
Change in Visceral Fat Mass (VFM) [Time Frame: Baseline to Week 12]
Description
VFM will be measured as an assessment of weight management.
Time Frame
12 weeks
Title
Change in Body Weight [Time Frame: Baseline to Week 12]
Description
Body weight will be measured as an assessment of weight management.
Time Frame
12 weeks
Title
Change in Waist Circumference. [Time Frame: Baseline to Week 12]
Description
Waist circumference will be measured as an assessment of weight management.
Time Frame
12 weeks
Title
Change in blood pressure. [Time Frame: Baseline to Week 12]
Description
Blood pressure will be measured as a marker of metabolic health. Both both systolic and diastolic blood pressure will be measured.
Time Frame
12 weeks
Title
Change in resting heart rate. [Time Frame: Baseline to Week 12]
Description
Resting heart rate will be measured as a marker of metabolic health.
Time Frame
12 weeks
Title
Changes in metabolic health symptoms. [Time Frame: Baseline to Week 12]
Description
Survey based assessment (0-5 scale) of changes in metabolic health symptoms.
Time Frame
12 weeks
Title
Changes in total cholesterol [Time Frame: Baseline to Week 12]
Description
Total cholesterol will be assessed as part of a lipid panel blood test.
Time Frame
12 weeks
Title
Changes in blood levels of triglycerides. [Time Frame: Baseline to Week 12]
Description
Triglycerides will be assessed as part of a lipid panel blood test.
Time Frame
12 weeks
Title
Changes in blood levels of high-density lipoprotein. [Time Frame: Baseline to Week 12]
Description
Blood levels of high-density lipoprotein will be assessed as part of a lipid panel blood test.
Time Frame
12 weeks
Title
Changes in blood levels of low-density lipoprotein. [Time Frame: Baseline to Week 12]
Description
Blood levels of low-density lipoprotein will be assessed as part of a lipid panel blood test.
Time Frame
12 weeks
Title
Changes in blood glucose. [Time Frame: Baseline to Week 12]
Description
Blood glucose levels will be assessed via blood test.
Time Frame
12 weeks
Title
Changes in blood insulin levels. [Time Frame: Baseline to Week 12]
Description
Blood insulin levels will be assessed via blood test.
Time Frame
12 weeks
Title
Changes in hbA1c. [Time Frame: Baseline to Week 12]
Description
hbA1c will be assessed via blood test.
Time Frame
12 weeks
Title
Changes in hs-high-sensitivity C-reactive protein (hsCRP). [Time Frame: Baseline to Week 12]
Description
hsCRP will be assessed via blood test.
Time Frame
12 weeks
Title
Changes in alanine transaminase. [Time Frame: Baseline to Week 12]
Description
Alanine transaminase will be assessed via blood test.
Time Frame
12 weeks
Title
Changes in aspartate aminotransferase. [Time Frame: Baseline to Week 12]
Description
Aspartate aminotransferase will be assessed via blood test.
Time Frame
12 weeks
Title
Changes in gamma-glutamyl transferase (GGT). [Time Frame: Baseline to Week 12]
Description
GGT will be assessed via blood test.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Changes in sleep duration. [Time Frame: Baseline to Week 12]
Description
Changes in sleep will be assessed by the participants using their own smart device (e.g. sleep tracker, Apple Watch, FitBit etc)
Time Frame
12 weeks
Title
Changes in participants-perceived sleep quality. [Time Frame: Baseline to Week 12]
Description
Changes in sleep quality will be assessed using study-specific surveys (0-5 scale).
Time Frame
12 weeks
Title
Changes in participant-reported mental wellbeing. [Time Frame: Baseline to Week 12]
Description
Mental well-being will be assessed study-specific surveys (0-5 scale).
Time Frame
12 weeks
Title
Changes in scores on the Anxiety GAD7 Questionnaire [Time Frame: Baseline to Week 12]
Description
Anxiety will be assessed using the validated Anxiety GAD7 Questionnaire (0-4 scale).
Time Frame
12 weeks
Title
Changes in health eating habits. [Time Frame: Baseline to Week 12]
Description
Changes in healthy eating habits and satiety will be assessed using the standardised Three-Factor Eating Questionnaire (0-4 scale).
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women & Men 18+ BMI between 25-32 (average BMI of subjects shall not exceed 30) 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 significantly compromise 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick Renner, MSc
Phone
4242450285
Email
hello@citruslabs.com
Facility Information:
Facility Name
Citruslabs
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

A Study to Evaluate the Effect of SlimBiotics L. Fermentum K8 Postbiotic on Weight Management and Metabolic Health Outcomes

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