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Sugar alcohols such as xylitol and erythritol are increasingly popular as sugar substitutes in the food industry and are also recommended to diabetic patients. Both substances are already in use in the food industry and are freely available. Since the 1970s, beneficial effects on oral health could be demonstrated as oral bacteria were influenced positively. Animal studies showed an increase in gut Clostridium perfringens after xylitol intake; certainly a non-desirable effect. However, studies on effects of erythritol and xylitol on the human gut microbiota are lacking so far. In this trial, investigators aim to examine whether gut microbiota and glucose tolerance can be influenced by polyol intake in a non-diabetic but obese cohort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | 20 obese, non-diabetic candidates will serve as control-group. All assessments are carried out just as in the intervention groups. | |
| E967-Xylitol | Active Comparator | 20 obese, non-diabetic candidates will receive a daily dose of 24g of xylitol. |
|
| E968-Erythritol | Active Comparator | 20 obese, non-diabetic candidates will receive a daily dose of 36g of erythritol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E967-Xylitol | Dietary Supplement |
|
| |
| E968-Erythritol |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose tolerance measured with oral glucose tolerance test | change from baseline to 8 weeks after polyol intake |
| Measure | Description | Time Frame |
|---|---|---|
| Human gut microbiota composition measured with metagenomic shotgun sequencing | change from baseline to 8 weeks after polyol intake | |
| Gut microbial-related metabolites in feces | Metabolomic analysis of the bacterial metabolites present in the feces by combining nuclear magnetic resonance (1H-NMR) and mass spectrometry |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christoph Beglinger, MD | St. Claraspital klinische Forschungsabteilung | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Endocrinology, Morbid Obesity and Preventive Medicine, Oslo University Hospital | Oslo | Norway | ||||
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D014993 | Xylitol |
| D004896 | Erythritol |
| ID | Term |
|---|---|
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
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Mullti-center trial
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| Dietary Supplement |
|
|
| change from baseline to 8 weeks after polyol intake |
| Gastrointestinal tolerance assessed by questionnaire | Gastrointestinal Symptoms Rating Scale (Svedlund et al) | change from baseline to 8 weeks after polyol intake |
| Gut microbial-related metabolites in urine | Metabolomic analysis of the bacterial metabolites present in the urine by combining nuclear magnetic resonance (1H-NMR) and mass spectrometry | change from baseline to 8 weeks after polyol intake |
| Endoscopic and Minimally Invasive Surgery Clinic of Stavropol State Medical University |
| Stavropol |
| Russia |
| St Claraspital | Basel | CH-4016 | Switzerland |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |