Clinical Study on the Effect of a Synbiotic on Body Fat Mass

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Type 2 Diabetes, Metabolic Syndrome, Obesity, Abdominal, Obesity, Visceral

Intervention / Treatment
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* Dietary Supplement: synbiotic
* Dietary Supplement: microcrystalline cellulose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Overweight or obese (BMI ≥ 25) Type 2 diabetes Age ≥ 18 Written informed consent Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised, controlled, double-blind
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: synbiotic<br>synbiotic consisting of three different strains of Lactobacillus fermentum + acacia gum (gum arabic) | Dietary Supplement: synbiotic<br>* 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<br>|
| Placebo Comparator: microcrystalline cellulose<br>microcrystalline cellulose | Dietary Supplement: microcrystalline cellulose<br>* Consumption of 6 g powder containing microcrystalline cellulose, maltodextrin , sucralose and flavour twice a day, resolved in water<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BFM | Body Fat Mass (BFM) as assessed by bioelectrical impedance analysis (BIA) (alteration V3-V1; verum versus placebo group) | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | Glycated Hemoglobin | 12 weeks | 
| HOMA-IR | HOMA-IR (Homeostasis Model Assessment (HOMA)-IR = glucose [mmol/L] x insulin [µU/ml]/22,5) as parameter for insulin resistance | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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synbiotic, body fat mass, metabolic syndrome, diabetes