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

Physiological Satiation Mechanisms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03039478
• Other study ID #: PolyDose
• Status: Completed
• Phase: N/A
• Start date: February 24, 2017
• Est. completion date: August 31, 2018

Study information

• Verified date: September 2018
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Physiological Satiation Mechanisms

Intervention

Dietary Supplement:
• Xylitol 7g
Xylitol 7g in 300mL tap water
• Erythritol 10g
Erythritol 10g in 300mL tap water
• Xylitol 17g
Xylitol 17g in 300mL tap water
• Xylitol 35g
Xylitol 35g in 300mL tap water
• Erythritol 25g
Erythritol 25g in 300mL tap water
• Erythritol 50g
Erythritol 50g in 300mL tap water

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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