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

Study Overview
=================
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.

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

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

Intervention / Treatment
-----------------
* Other: Slimbiotics Postbiotic
* Other: Placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial. Participants will be randomized into the intervention group (SlimBiotics Postbiotic) or into a placebo product control group
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group (SlimBiotic Postbiotic)<br>Participants will take 1 serving (1 capsule) per day. | Other: Slimbiotics Postbiotic<br>* SlimBiotics postbiotic formula contains the following ingredients: Heat-inactivated L. fermentum K8 Postbiotic. Microcrystalline cellulose.<br>|
| Placebo Comparator: Placebo Group<br>Participants will take 1 serving (1 capsule) per day. | Other: Placebo<br>* The placebo capsules contain microcrystalline cellulose only.<br>|

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] | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 12 weeks | 
| 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 | 
| 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 | 
| 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 | 
| 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 |