A Study to Evaluate the Effect of SlimBiotics Probiotic Formula on Weight Management and Metabolic Health Outcomes

Slimbiotics

Status

Completed

Conditions

Weight Loss

Healthy Eating

Metabolic Health

Sleep

Well-Being, Psychological

Stress

Treatments

Other: Slimbiotic Probiotic

Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT05917314

20317

Details and patient eligibility

About

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

Enrollment

120 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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