Status:
UNKNOWN
Effect of Synbiotic L. Fermentum Strains on Body Fat Mass
Lead Sponsor:
Slimbiotics GmbH
Collaborating Sponsors:
Clinical Research Center Kiel GmbH
Conditions:
Weight, Body
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In this placebo-controlled trial the effect of a synbiotic consisting of three different strains of Lactobacillus fermentum and acacia gum (gum arabic) was compared with a probiotic formulation contai...
Detailed Description
The effects of probiotics on glucose and lipid metabolism, on body fat, weight, visceral fat and liver steatosis were shown by several meta-analyses for the total variety, as described above. Some pro...
Eligibility Criteria
Inclusion
- Overweight or obese (BMI ≥ 25)
- Elevated waist circumference (\>94cm and \>80cm (for European men and women, respectively)
- Age ≥ 18
- Written informed consent
Exclusion
- 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 OTC, which may have impact on the study aims (e. g. probiotics containing supplements, laxatives, steroids etc.)
- History of hepatitis B, C, HIV
- Major cognitive or psychiatric disorders
- 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
- Anorexic drugs
- Present drug abuse or alcoholism
- Legal incapacity
Key Trial Info
Start Date :
June 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2022
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT05405205
Start Date
June 8 2021
End Date
August 1 2022
Last Update
June 6 2022
Active Locations (1)
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1
Clincal Research Center Kiel GmbH
Kiel, Schleswig-Holstein, Germany, 24118