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

NCT ID: NCT03039478

Last Updated: 2018-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-24

Study Completion Date

2018-08-31

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.

Detailed Description

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Conditions

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Physiological Satiation Mechanisms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Parallel assignment
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Xylitol 7g in 300mL tap water

12 volunteers receive 7g xylitol in 300mL tap water via a nasogastric tube

Group Type ACTIVE_COMPARATOR

Xylitol 7g

Intervention Type DIETARY_SUPPLEMENT

Xylitol 7g in 300mL tap water

Xylitol 17g in 300mL tap water

12 volunteers receive 17g xylitol in 300mL tap water via a nasogastric tube

Group Type ACTIVE_COMPARATOR

Xylitol 17g

Intervention Type DIETARY_SUPPLEMENT

Xylitol 17g in 300mL tap water

Xylitol 35g in 300mL tap water

12 volunteers receive 35g xylitol in 300mL tap water via a nasogastric tube

Group Type ACTIVE_COMPARATOR

Xylitol 35g

Intervention Type DIETARY_SUPPLEMENT

Xylitol 35g in 300mL tap water

Erythritol 10g in 300mL tap water

12 volunteers receive 10g erythritol in 300mL tap water via a nasogastric tube

Group Type ACTIVE_COMPARATOR

Erythritol 10g

Intervention Type DIETARY_SUPPLEMENT

Erythritol 10g in 300mL tap water

Erythritol 25g in 300mL tap water

12 volunteers receive 25g erythritol in 300mL tap water via a nasogastric tube

Group Type ACTIVE_COMPARATOR

Erythritol 25g

Intervention Type DIETARY_SUPPLEMENT

Erythritol 25g in 300mL tap water

Erythritol 50g in 300mL tap water

12 volunteers receive 50g erythritol in 300mL tap water via a nasogastric tube

Group Type ACTIVE_COMPARATOR

Erythritol 50g

Intervention Type DIETARY_SUPPLEMENT

Erythritol 50g in 300mL tap water

Interventions

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Xylitol 7g

Xylitol 7g in 300mL tap water

Intervention Type DIETARY_SUPPLEMENT

Erythritol 10g

Erythritol 10g in 300mL tap water

Intervention Type DIETARY_SUPPLEMENT

Xylitol 17g

Xylitol 17g in 300mL tap water

Intervention Type DIETARY_SUPPLEMENT

Xylitol 35g

Xylitol 35g in 300mL tap water

Intervention Type DIETARY_SUPPLEMENT

Erythritol 25g

Erythritol 25g in 300mL tap water

Intervention Type DIETARY_SUPPLEMENT

Erythritol 50g

Erythritol 50g in 300mL tap water

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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E967-Xylitol E968-Erythritol E967-Xylitol E967-Xylitol E968-Erythritol E968-Erythritol

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christoph Beglinger, Prof

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

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University Hospital Basel

Basel, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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PolyDose

Identifier Type: -

Identifier Source: org_study_id

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