Clinical trial NCT04754464: Clinical Study on the Effect of a Synbiotic on Body Fat Mass
Official title: Randomised, Controlled, Double-blind Clinical Study on the Effect of a Synbiotic on Body Fat Mass, Weight Management, Metabolic Syndrome and Other Risk Factors for CVD and Diabetes, on Fecal Microbiota and Adverse Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Metabolic Syndrome
Obesity, Abdominal
Obesity, Visceral
Keywords: synbiotic
body fat mass
metabolic syndrome
diabetes
Lead sponsor: Slimbiotics
Sponsor class: UNKNOWN
Collaborators: name: Clinical Research Center Kiel GmbH
First posted: 2021-02-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised, controlled, double-blind
Primary purpose: TREATMENT

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 resistance and other risk factors for CVD and diabetes in overweight type 2 diabetics is investigated.

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 probiotic species/strains, however, seem to be more efficacious. The lactobacilli used in this trial were selected for their anti-inflammatory properties and based on induction of defensins in enterocytes. Therefore, one may expect more pronounced effects of these strains on traits of the metabolic syndrome, which is driven by low grade inflammation, than those found in the meta-analyses for the whole variety of probiotics without discriminating species and strain specificity.

The combination of these Lactobacillus strains with acacia gum is expected to enable even more pronounce effects, since acacia gum was shown to increase the number of lactobacilli in the gut and, hence, are supposed to promote their propagation and, hence their effects. The dosage of 10 g/day acacia gum was demonstrated to be sufficient for enhancing fecal lactobacilli and bifidobacterial.

Eligibility criteria: Inclusion Criteria:

1. Overweight or obese (BMI ≥ 25)
2. Type 2 diabetes
3. Age ≥ 18
4. Written informed consent

Exclusion Criteria:

Any of the following is regarded as a criterion for exclusion from enrollment into the study:

1. Subjects currently enrolled in another clinical study
2. Subjects having finished another clinical study within the last 4 weeks before inclusion
3. Hypersensitivity, allergy or intolerance against any compound of the test products (e. g. acacia gum)
4. Condition after implantation of a cardiac pacemaker or other active implants
5. Antidiabetic drugs except metformin
6. 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
7. History of hepatitis B, C, HIV
8. History of or present liver deficiency as defined by Quick \< 70%
9. Regular medical treatment including OTC, which may have impact on the study aims (e.g. probiotics containing supplements etc.)
10. Major cognitive or psychiatric disorders
11. Subjects who are scheduled to undergo any diagnostic intervention or hospitalization which may cause protocol deviations
12. Simultaneous study participation by members of the same household
13. Pregnancy and lactation
14. Any diet to lose body weight
15. Eating disorders or vegan diet
16. Anorexic drugs and laxatives
17. Present drug abuse or alcoholism
18. Legal incapacity

Primary outcomes:
measure: BFM
timeFrame: 12 weeks
Secondary outcomes:
measure: HbA1c
timeFrame: 12 weeks
measure: HOMA-IR
timeFrame: 12 weeks
Other outcomes:
measure: WC
timeFrame: 12 weeks
measure: WHtR
timeFrame: 12 weeks
Locations:
city: Vienna
country: Austria
facility: Slimbiotics GmbH
city: Kiel
country: Germany
facility: Clinical Research Center Kiel
Study officials:
affiliation: Clinical Research Center Kiel
name: Christiane Laue, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: