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

Slimbiotics

Status: Not yet enrolling

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

Treatments: Other: Placebo; Other: Slimbiotics Postbiotic

Study type: Interventional

Funder types: Industry

Identifiers

NCT05912699

20277

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Intervention Group (SlimBiotic Postbiotic)

Experimental group

Description:

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

Treatment:

Other: Slimbiotics Postbiotic

Placebo Group

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo