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

Not Applicable

Completed

• Conditions: Physiological Satiation Mechanisms

• Registration Number: NCT03039478
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-31
• Study First Submitted QC: 2017-01-31
• Study First Posted: 2017-02-01
• Study Start: 2017-02-24
• Primary Completion: 2018-08-31
• Study Completion: 2018-08-31
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-14
• Last Update Posted: 2018-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Basel; 🇨🇭 Basel, Switzerland