Physiological Satiation MechanismsNCT03039478
Effect of Different Concentrations of Xylitol and Erythritol on Gut Peptide Release and Gastric Emptying in Humans
A study testing Xylitol 7g, Erythritol 10g and Xylitol 17g in people with Physiological Satiation Mechanisms, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Physiological Satiation Mechanisms
- What is being tested?
- Xylitol 7g, Erythritol 10g and Xylitol 17g
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSwitzerland
- Study dates
- 24 Feb 2017to 31 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Physiological Satiation Mechanisms
- Being tested
- Xylitol 7g, Erythritol 10g, Xylitol 17g, Xylitol 35g, Erythritol 25g
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xylitol 7gDietary supplement
Also called E967-Xylitol
Xylitol 7g in 300mL tap water
Erythritol 10gDietary supplement
Also called E968-Erythritol
Erythritol 10g in 300mL tap water
Xylitol 17gDietary supplement
Also called E967-Xylitol
Xylitol 17g in 300mL tap water
Xylitol 35gDietary supplement
Also called E967-Xylitol
Xylitol 35g in 300mL tap water
Erythritol 25gDietary supplement
Also called E968-Erythritol
Erythritol 25g in 300mL tap water
Erythritol 50gDietary supplement
Also called E968-Erythritol
Erythritol 50g in 300mL tap water
| Study group | Role | What they receive |
|---|---|---|
| Xylitol 7g in 300mL tap water | Active comparator | 12 volunteers receive 7g xylitol in 300mL tap water via a nasogastric tube Receives: Dietary Supplement: Xylitol 7g |
| Xylitol 17g in 300mL tap water | Active comparator | 12 volunteers receive 17g xylitol in 300mL tap water via a nasogastric tube Receives: Dietary Supplement: Xylitol 17g |
| Xylitol 35g in 300mL tap water | Active comparator | 12 volunteers receive 35g xylitol in 300mL tap water via a nasogastric tube Receives: Dietary Supplement: Xylitol 35g |
| Erythritol 10g in 300mL tap water | Active comparator | 12 volunteers receive 10g erythritol in 300mL tap water via a nasogastric tube Receives: Dietary Supplement: Erythritol 10g |
| Erythritol 25g in 300mL tap water | Active comparator | 12 volunteers receive 25g erythritol in 300mL tap water via a nasogastric tube Receives: Dietary Supplement: Erythritol 25g |
| Erythritol 50g in 300mL tap water | Active comparator | 12 volunteers receive 50g erythritol in 300mL tap water via a nasogastric tube Receives: Dietary Supplement: Erythritol 50g |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute effect on cholecystokinin ( CCK) release
effect on CCK release measured by a commercially available ELISA kit (enzyme-linked immunosorbent assay)
Measured: changes from baseline to three hours after treatment
Secondary outcomes (2)
Acute effects on gastric emptying
Acute effects on gastric emptying measured by 13C-sodium-acetate breath test
Measured: 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
Measured: changes from baseline to three hours after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study start24 Feb 2017
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physiological Satiation MechanismsStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Parallel assignment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christoph Beglinger, Prof, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03039478
- Sponsor's protocol ID
- PolyDose
- Status last verified
- Sep 2018
- First submitted
- 31 Jan 2017
- Last updated
- 17 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03039478
- Acronym / sponsor ID
- PolyDose
- Conditions
- Physiological Satiation Mechanisms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 24 Feb 2017 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 1 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 6
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Xylitol 7g in 300mL tap water | Active comparator | Dietary Supplement: Xylitol 7g12 volunteers receive 7g xylitol in 300mL tap water via a nasogastric tube |
| Xylitol 17g in 300mL tap water | Active comparator | Dietary Supplement: Xylitol 17g12 volunteers receive 17g xylitol in 300mL tap water via a nasogastric tube |
| Xylitol 35g in 300mL tap water | Active comparator | Dietary Supplement: Xylitol 35g12 volunteers receive 35g xylitol in 300mL tap water via a nasogastric tube |
| Erythritol 10g in 300mL tap water | Active comparator | Dietary Supplement: Erythritol 10g12 volunteers receive 10g erythritol in 300mL tap water via a nasogastric tube |
| Erythritol 25g in 300mL tap water | Active comparator | Dietary Supplement: Erythritol 25g12 volunteers receive 25g erythritol in 300mL tap water via a nasogastric tube |
| Erythritol 50g in 300mL tap water | Active comparator | Dietary Supplement: Erythritol 50g12 volunteers receive 50g erythritol in 300mL tap water via a nasogastric tube |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xylitol 7gAlso: E967-XylitolXylitol 7g in 300mL tap water | Dietary supplement | Xylitol 7g in 300mL tap water |
| Erythritol 10gAlso: E968-ErythritolErythritol 10g in 300mL tap water | Dietary supplement | Erythritol 10g in 300mL tap water |
| Xylitol 17gAlso: E967-XylitolXylitol 17g in 300mL tap water | Dietary supplement | Xylitol 17g in 300mL tap water |
| Xylitol 35gAlso: E967-XylitolXylitol 35g in 300mL tap water | Dietary supplement | Xylitol 35g in 300mL tap water |
| Erythritol 25gAlso: E968-ErythritolErythritol 25g in 300mL tap water | Dietary supplement | Erythritol 25g in 300mL tap water |
| Erythritol 50gAlso: E968-ErythritolErythritol 50g in 300mL tap water | Dietary supplement | Erythritol 50g in 300mL tap water |
Primary outcome
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)
2 secondary outcomes
Acute effects on gastric emptying
Time frame: changes from baseline to three hours after treatment
Acute effects on subjective feelings of hunger and satiety
Time frame: changes from baseline to three hours after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2018.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Beglinger, Prof principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xylitol 7g, Erythritol 10g and Xylitol 17g in people with Physiological Satiation Mechanisms, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute effect on cholecystokinin ( CCK) release (time frame: changes from baseline to three hours after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2018.