Effect of Different Concentrations of Xylitol and Erythritol on Gut Peptide Release and Gastric Emptying in Humans
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2017
CompletedFirst Posted
Study publicly available on registry
February 1, 2017
CompletedStudy Start
First participant enrolled
February 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2018
CompletedSeptember 17, 2018
September 1, 2018
1.5 years
January 31, 2017
September 14, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Acute effects on gastric emptying
changes from baseline to three hours after treatment
Acute effects on subjective feelings of hunger and satiety
changes from baseline to three hours after treatment
Study Arms (6)
Xylitol 7g in 300mL tap water
ACTIVE COMPARATOR12 volunteers receive 7g xylitol in 300mL tap water via a nasogastric tube
Xylitol 17g in 300mL tap water
ACTIVE COMPARATOR12 volunteers receive 17g xylitol in 300mL tap water via a nasogastric tube
Xylitol 35g in 300mL tap water
ACTIVE COMPARATOR12 volunteers receive 35g xylitol in 300mL tap water via a nasogastric tube
Erythritol 10g in 300mL tap water
ACTIVE COMPARATOR12 volunteers receive 10g erythritol in 300mL tap water via a nasogastric tube
Erythritol 25g in 300mL tap water
ACTIVE COMPARATOR12 volunteers receive 25g erythritol in 300mL tap water via a nasogastric tube
Erythritol 50g in 300mL tap water
ACTIVE COMPARATOR12 volunteers receive 50g erythritol in 300mL tap water via a nasogastric tube
Interventions
Xylitol 7g in 300mL tap water
Erythritol 10g in 300mL tap water
Xylitol 17g in 300mL tap water
Xylitol 35g in 300mL tap water
Erythritol 25g in 300mL tap water
Erythritol 50g in 300mL tap water
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Basel
Basel, 4031, Switzerland
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christoph Beglinger, Prof
University Hospital, Basel, Switzerland
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2017
First Posted
February 1, 2017
Study Start
February 24, 2017
Primary Completion
August 31, 2018
Study Completion
August 31, 2018
Last Updated
September 17, 2018
Record last verified: 2018-09