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

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