Metabolic Syndrome, Obesity, Abdominal, Obesity, Visceral, Type 2 Diabetes
Conditions
Keywords
synbiotic, body fat mass, metabolic syndrome, diabetes
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.
Interventions
DIETARY_SUPPLEMENTsynbiotic
Consumption of 6 g powder consisting of the strains Lactobacillus fermentum K7-Lb1, L. fermentum K8-Lb1, L. fermentum K11-Lb3, acacia gum (gum arabic), maltodextrin, sucralose and flavour twice a day resolved in water
DIETARY_SUPPLEMENTmicrocrystalline cellulose
Consumption of 6 g powder containing microcrystalline cellulose, maltodextrin , sucralose and flavour twice a day, resolved in water
Sponsors
Clinical Research Center Kiel GmbH
Slimbiotics GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Placebo products are identical with verum in smell, flavour, color, texture, appearance, packaging (sachets) and labelling.
Intervention model description
Randomised, controlled, double-blind
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BFM | 12 weeks | Body Fat Mass (BFM) as assessed by bioelectrical impedance analysis (BIA) (alteration V3-V1; verum versus placebo group) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 12 weeks | Glycated Hemoglobin |
| HOMA-IR | 12 weeks | HOMA-IR (Homeostasis Model Assessment (HOMA)-IR = glucose \[mmol/L\] x insulin \[µU/ml\]/22,5) as parameter for insulin resistance |
Other
| Measure | Time frame | Description |
|---|---|---|
| WC | 12 weeks | Waist Circumference |
| WHtR | 12 weeks | waist-to-height ratio |
Countries
Austria, Germany
Outcome results
None listed