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| Name | Class |
|---|---|
| Clinical Research Center Kiel GmbH | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| synbiotic | Active Comparator | synbiotic consisting of three different strains of Lactobacillus fermentum + acacia gum (gum arabic) |
|
| microcrystalline cellulose | Placebo Comparator | microcrystalline cellulose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| synbiotic | Dietary Supplement | 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| WC | Waist Circumference | 12 weeks |
| WHtR | waist-to-height ratio | 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
Any of the following is regarded as a criterion for exclusion from enrollment into the study:
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| Name | Affiliation | Role |
|---|---|---|
| Christiane Laue, Dr. med. | Clinical Research Center Kiel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Slimbiotics GmbH | Vienna | 1010 | Austria | |||
| Clinical Research Center Kiel |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D024821 | Metabolic Syndrome |
| D056128 | Obesity, Abdominal |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D058616 | Synbiotics |
| C109691 | microcrystalline cellulose |
| ID | Term |
|---|---|
| D056692 | Prebiotics |
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
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Randomised, controlled, double-blind
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Placebo products are identical with verum in smell, flavour, color, texture, appearance, packaging (sachets) and labelling.
| microcrystalline cellulose | Dietary Supplement | Consumption of 6 g powder containing microcrystalline cellulose, maltodextrin , sucralose and flavour twice a day, resolved in water |
|
| 12 weeks |
| Kiel |
| 24118 |
| Germany |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010829 |
| Physiological Phenomena |
| D019936 | Probiotics |
| D019602 | Food and Beverages |