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Completed

NCT Number: NCT03039478

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

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Key information

Conditions

Physiological Satiation Mechanisms

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Basel

Basel, 4031, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Xylitol 7g

Dietary Supplement

Xylitol 7g in 300mL tap water

Other names: E967-Xylitol

Erythritol 10g

Dietary Supplement

Erythritol 10g in 300mL tap water

Other names: E968-Erythritol

Xylitol 17g

Dietary Supplement

Xylitol 17g in 300mL tap water

Other names: E967-Xylitol

Xylitol 35g

Dietary Supplement

Xylitol 35g in 300mL tap water

Other names: E967-Xylitol

Erythritol 25g

Dietary Supplement

Erythritol 25g in 300mL tap water

Other names: E968-Erythritol

Erythritol 50g

Dietary Supplement

Erythritol 50g in 300mL tap water

Other names: E968-Erythritol

Primary outcomes

  1. Acute effect on cholecystokinin ( CCK) release

    Time frame: changes from baseline to three hours after treatment

    effect on CCK release measured by a commercially available ELISA kit (enzyme-linked immunosorbent assay)

Secondary outcomes

  1. Acute effects on gastric emptying

    Time frame: changes from baseline to three hours after treatment

    Acute effects on gastric emptying measured by 13C-sodium-acetate breath test

  2. Acute effects on subjective feelings of hunger and satiety

    Time frame: changes from baseline to three hours after treatment

    Acute effects on subjective feelings of hunger and satiety measured by visual analogue scales

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 1, 2017
Registry last updated
Sep 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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