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

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

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.

Study Overview

• Status: Completed
• Conditions: Physiological Satiation Mechanisms
• Intervention / Treatment: Dietary supplement: Xylitol 7g; Dietary supplement: Xylitol 17g; Dietary supplement: Xylitol 35g; Dietary supplement: Erythritol 10g; Dietary supplement: Erythritol 25g; Dietary supplement: Erythritol 50g

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • University Hospital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2017
• Primary Completion (Actual): August 31, 2018
• Study Completion (Actual): August 31, 2018

Study Registration Dates

• First Submitted: January 31, 2017
• First Submitted That Met QC Criteria: January 31, 2017
• First Posted (Estimate): February 1, 2017

Study Record Updates

• Last Update Posted (Actual): September 17, 2018
• Last Update Submitted That Met QC Criteria: September 14, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vasodilator Agents; Erythritol
• Other Study ID Numbers: PolyDose

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No