ObesityNCT02821923
Effect of the Natural Sweeteners Erythritol and Xylitol on Vascular Function in Obese Volunteers
A study testing E967-Xylitol and E968-Erythritol in people with Obesity, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Sugar alcohols such as xylitol and erythritol are increasingly popular as sugar substitutes in the food industry and are also recommended to diabetic patients. Both substances are already in use in the food industry and are freely available. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Obesity
- What is being tested?
- E967-Xylitol and E968-Erythritol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSwitzerland
- Study dates
- 7 Nov 2016to 10 Mar 2022
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Obese volunteers (BMI > 30kg/m2)
- Aged 18- max. 55 years
- Otherwise healthy.
Who cannot join
- Known cardiovascular disease
- Diabetes mellitus
- Smoking and drug abuse
- Arterial hypertension with antihypertensive treatment
- Dyslipidaemia with statin therapy
- Known chronic hepatic disease (NASH, hepatitis).
Show all 11Show fewer
- Known renal disease: kidney failure
- Pregnancy
- Chronical diseases of the gastrointestinal tract, history of gastrointestinal surgery with major changes to the gastrointestinal tract
- Substance abuse, alcohol abuse.
- Inability to follow procedures due to psychological disorders, dementia or insufficient knowledge of project language (German).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the Natural Sweeteners Erythritol and Xylitol on Vascular Function in Obese Volunteers: A Pilot Study
Sugar alcohols such as xylitol and erythritol are increasingly popular as sugar substitutes in the food industry and are also recommended to diabetic patients. Both substances are already in use in the food industry and are freely available. Since the 1970s, beneficial effects on oral health could be demonstrated as oral bacteria were influenced positively. A pilot study recently undertaken in the US (Flint N, 2014) has shown that diabetics profit from a daily intake of erythritol, as this natural sweetener enhances the elasticity of the blood vessels. In this trial, investigators aim to examine whether this effect can be found in a non-diabetic but obese cohort, and whether also xylitol improves vascular function.
- Conditions
- Obesity
- Being tested
- E967-Xylitol, E968-Erythritol
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E967-XylitolDietary supplement
24g xylitol/d
E968-ErythritolDietary supplement
36g erythritol/d
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | no treatment |
| E967-Xylitol | Active comparator | 24g xylitol/d Receives: Dietary Supplement: E967-Xylitol |
| E968-Erythritol | Active comparator | 36g erythritol/d Receives: Dietary Supplement: E968-Erythritol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central arterial stiffness measured by sonography
Measured: Change from baseline to 5 weeks after intake of polyol
Secondary outcomes (1)
Glucose tolerance measured by oral glucose tolerance test
Measured: Change from baseline to 5 weeks after intake of polyol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2016 (estimated)
- Study start7 Nov 2016
- Primary completion10 Mar 2022
- Study completion10 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christoph Beglinger, MD, Study chair, St. Claraspital Basel klinische Forschungsabteilung
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02821923
- Sponsor's protocol ID
- Poly Vasc
- Status last verified
- May 2022
- First submitted
- 27 Jun 2016
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Bordier V, Teysseire F, Drewe J, Madorin P, Bieri O, Schmidt-Trucksass A, Hanssen H, Beglinger C, Meyer-Gerspach AC, Wolnerhanssen BK. Effects of a 5-week intake of erythritol and xylitol on vascular function, abdominal fat and glucose tolerance in humans with obesity: a pilot trial. BMJ Nutr Prev Health. 2023 Nov 14;6(2):264-272. doi: 10.1136/bmjnph-2023-000764. eCollection 2023.
PubMed 38618550
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Natural Sweeteners Erythritol and Xylitol on Vascular Function in Obese Volunteers: A Pilot Study
- ClinicalTrials.gov ID
- NCT02821923
- Acronym / sponsor ID
- Poly Vasc
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 7 Nov 2016 (actual)
- Primary completion
- 10 Mar 2022 (actual)
- Study completion
- 10 Mar 2022 (actual)
- First posted
- 4 Jul 2016 (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.
Sugar alcohols such as xylitol and erythritol are increasingly popular as sugar substitutes in the food industry and are also recommended to diabetic patients. Both substances are already in use in the food industry and are freely available. Since the 1970s, beneficial effects on oral health could be demonstrated as oral bacteria were influenced positively. A pilot study recently undertaken in the US (Flint N, 2014) has shown that diabetics profit from a daily intake of erythritol, as this natural sweetener enhances the elasticity of the blood vessels. In this trial, investigators aim to examine whether this effect can be found in a non-diabetic but obese cohort, and whether also xylitol improves vascular function.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –no treatment |
| E967-Xylitol | Active comparator | Dietary Supplement: E967-Xylitol24g xylitol/d |
| E968-Erythritol | Active comparator | Dietary Supplement: E968-Erythritol36g erythritol/d |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Obese volunteers (BMI > 30kg/m2)
- Aged 18- max. 55 years
- Otherwise healthy.
Key exclusion criteria (11 listed)
- Known cardiovascular disease
- Diabetes mellitus
- Smoking and drug abuse
- Arterial hypertension with antihypertensive treatment
- Dyslipidaemia with statin therapy
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 |
|---|---|---|
| E967-Xylitol24g xylitol/d | Dietary supplement | E967-Xylitol |
| E968-Erythritol36g erythritol/d | Dietary supplement | E968-Erythritol |
Primary outcome
Central arterial stiffness measured by sonography
Time frame: Change from baseline to 5 weeks after intake of polyol
1 secondary outcome
Glucose tolerance measured by oral glucose tolerance test
Time frame: Change from baseline to 5 weeks after intake of polyol
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 18 May 2022.
- Derived from this study: PubMed 38618550Bordier V, Teysseire F, Drewe J, Madorin P, Bieri O, Schmidt-Trucksass A, Hanssen H, Beglinger C, Meyer-Gerspach AC, Wolnerhanssen BK. Effects of a 5-week intake of erythritol and xylitol on vascular function, abdominal fat and glucose tolerance in humans with obesity: a pilot trial. BMJ Nutr Prev Health. 2023 Nov 14;6(2):264-272. doi: 10.1136/bmjnph-2023-000764. eCollection 2023.
- Individual participant dataSharing planned: Undecided
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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, MD study chair
St. Claraspital Basel klinische Forschungsabteilung
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E967-Xylitol and E968-Erythritol in people with Obesity, 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 3 inclusion and 11 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 18 May 2022. 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?
Central arterial stiffness measured by sonography (time frame: Change from baseline to 5 weeks after intake of polyol). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02821923, which also lists 1 linked publication.
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 18 May 2022.