Status:
COMPLETED
Clinical Study on the Effect of a Synbiotic on Body Fat Mass
Lead Sponsor:
Slimbiotics GmbH
Collaborating Sponsors:
Clinical Research Center Kiel GmbH
Conditions:
Type 2 Diabetes
Metabolic Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In this trial the effect of a synbiotic consisting of the three different strains of Lactobacillus fermentum and acacia gum (gum arabic) on body fat mass, body weight, long-term glycemia, insulin resi...
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)
- Type 2 diabetes
- Age ≥ 18
- Written informed consent
Exclusion
- Any of the following is regarded as a criterion for exclusion from enrollment into the study:
- 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
- Antidiabetic drugs except metformin
- 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 hepatitis B, C, HIV
- 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 etc.)
- 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
- Any diet to lose body weight
- Eating disorders or vegan diet
- Anorexic drugs and laxatives
- Present drug abuse or alcoholism
- Legal incapacity
Key Trial Info
Start Date :
May 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2022
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04754464
Start Date
May 13 2020
End Date
May 31 2022
Last Update
June 1 2022
Active Locations (2)
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1
Slimbiotics GmbH
Vienna, Austria, 1010
2
Clinical Research Center Kiel
Kiel, Germany, 24118