Effect of Different Concentrations of Xylitol and Erythritol on Gut Peptide Release and Gastric Emptying in Humans

Study Overview
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Brief Summary
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Xylitol and erythritol have become increasingly popular as sugar substitutes in the food industry. Both substances are freely available. While glucose ingestion stimulates satiation hormone secretion in the gut and slows down gastric emptying, artificial sweeteners such as aspartame, sucralose and acesulfame-K have no such effect. However, acute intake of 50g xylitol or 75g erythritol in 300mL tap water leads to a marked increase in the satiation hormones and induces a significant retardation in gastric emptying. The concentrations used to Show this effect were rather high (50g xylitol and 75g erythritol) and led to bloating and diarrhea in 60-70% of all subjects two hours after administration. The aim of the present study is to find an effective concentration of xylitol and erythritol still stimulating satiation hormone release without any gastrointestinal adverse events.

Official Title
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Effect of Different Concentrations of Xylitol and Erythritol on the Release of Gastrointestinal Peptides and on Gastric Emptying Rates in Healthy Normal Weight Humans

Conditions
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Physiological Satiation Mechanisms

Intervention / Treatment
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* Dietary Supplement: Xylitol 7g
* Dietary Supplement: Erythritol 10g
* Dietary Supplement: Xylitol 17g
* Dietary Supplement: Xylitol 35g
* Dietary Supplement: Erythritol 25g
* Dietary Supplement: Erythritol 50g


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy normal weight subjects with a body-mass index of 19.0-24.9 Normal eating habits (no diets; no dietary changes; no special dietary habits, such as vegetarian/vegan) Age 18-40 years Stable body weight for at least three months Informed Consent as documented by signature Exclusion Criteria: Pre-existing consumption of xylitol or erythritol on a regular basis (usage of xylitol or erythritol as sugar replacement; xylitol or erythritol containing toothpaste is allowed) Regular intake of medications (except for oral contraceptives) Evidence of relevant cardiovascular, pulmonary, renal, hepatic, pancreatic, gastrointestinal, metabolic, endocrinological, neurological, psychiatric or other diseases at screening Clinically relevant abnormalities in haematological laboratory parameters Food allergies, food intolerance Pregnancy Participation in another study with investigational drug within the 30 days preceding and during the present study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Parallel assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Xylitol 7g in 300mL tap water<br>12 volunteers receive 7g xylitol in 300mL tap water via a nasogastric tube | Dietary Supplement: Xylitol 7g<br>* Xylitol 7g in 300mL tap water<br>* Other names: E967-Xylitol;|
| Active Comparator: Xylitol 17g in 300mL tap water<br>12 volunteers receive 17g xylitol in 300mL tap water via a nasogastric tube | Dietary Supplement: Xylitol 17g<br>* Xylitol 17g in 300mL tap water<br>* Other names: E967-Xylitol;|
| Active Comparator: Xylitol 35g in 300mL tap water<br>12 volunteers receive 35g xylitol in 300mL tap water via a nasogastric tube | Dietary Supplement: Xylitol 35g<br>* Xylitol 35g in 300mL tap water<br>* Other names: E967-Xylitol;|
| Active Comparator: Erythritol 10g in 300mL tap water<br>12 volunteers receive 10g erythritol in 300mL tap water via a nasogastric tube | Dietary Supplement: Erythritol 10g<br>* Erythritol 10g in 300mL tap water<br>* Other names: E968-Erythritol;|
| Active Comparator: Erythritol 25g in 300mL tap water<br>12 volunteers receive 25g erythritol in 300mL tap water via a nasogastric tube | Dietary Supplement: Erythritol 25g<br>* Erythritol 25g in 300mL tap water<br>* Other names: E968-Erythritol;|
| Active Comparator: Erythritol 50g in 300mL tap water<br>12 volunteers receive 50g erythritol in 300mL tap water via a nasogastric tube | Dietary Supplement: Erythritol 50g<br>* Erythritol 50g in 300mL tap water<br>* Other names: E968-Erythritol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute effect on cholecystokinin ( CCK) release | effect on CCK release measured by a commercially available ELISA kit (enzyme-linked immunosorbent assay) | changes from baseline to three hours after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute effects on gastric emptying | Acute effects on gastric emptying measured by 13C-sodium-acetate breath test | changes from baseline to three hours after treatment | 
| Acute effects on subjective feelings of hunger and satiety | Acute effects on subjective feelings of hunger and satiety measured by visual analogue scales | changes from baseline to three hours after treatment |