ObesityNCT02824614
Effect of the Natural Sweeteners Erythritol and Xylitol on Gut Microbiota and Glucose Metabolism in Obese Volunteers
A study testing E967-Xylitol and E968-Erythritol in people with Obesity, run by University Hospital, Basel, Switzerland at 3 sites in 3 countries.
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
- 64 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Jun 2016to Feb 2020
- 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
- Arterial Hypertension with medication
- Dyslipidaemia with medication
- Known chronic hepatic disease (NASH, hepatitis).
- Known renal disease: kidney failure
Show all 13Show fewer
- Pregnancy
- Intake of proton pump inhibitors (PPIs) on a regular basis
- Intake of antibiotics within the last 3 months before inclusion
- Intake of pro or prebiotics
- 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
3 sites in 3 countries.
3 sites in 3 countries
Norway1 site
Department of Endocrinology, Morbid Obesity and Preventive Medicine, Oslo University Hospital
Oslo
Russia1 site
Endoscopic and Minimally Invasive Surgery Clinic of Stavropol State Medical University
Stavropol
About this 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. Animal studies showed an increase in gut Clostridium perfringens after xylitol intake; certainly a non-desirable effect. However, studies on effects of erythritol and xylitol on the human gut microbiota are lacking so far. In this trial, investigators aim to examine whether gut microbiota and glucose tolerance can be influenced by polyol intake in a non-diabetic but obese cohort.
- 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
Also called Xylitol
E968-ErythritolDietary supplement
Also called Erythritol
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 20 obese, non-diabetic candidates will serve as control-group. All assessments are carried out just as in the intervention groups. |
| E967-Xylitol | Active comparator | 20 obese, non-diabetic candidates will receive a daily dose of 24g of xylitol. Receives: Dietary Supplement: E967-Xylitol |
| E968-Erythritol | Active comparator | 20 obese, non-diabetic candidates will receive a daily dose of 36g of erythritol. Receives: Dietary Supplement: E968-Erythritol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose tolerance measured with oral glucose tolerance test
Measured: change from baseline to 8 weeks after polyol intake
Secondary outcomes (4)
Human gut microbiota composition measured with metagenomic shotgun sequencing
Measured: change from baseline to 8 weeks after polyol intake
Gut microbial-related metabolites in feces
Metabolomic analysis of the bacterial metabolites present in the feces by combining nuclear magnetic resonance (1H-NMR) and mass spectrometry
Measured: change from baseline to 8 weeks after polyol intake
Gastrointestinal tolerance assessed by questionnaire
Gastrointestinal Symptoms Rating Scale (Svedlund et al)
Measured: change from baseline to 8 weeks after polyol intake
Gut microbial-related metabolites in urine
Metabolomic analysis of the bacterial metabolites present in the urine by combining nuclear magnetic resonance (1H-NMR) and mass spectrometry
Measured: change from baseline to 8 weeks after polyol intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study startJun 2016
- Primary completionFeb 2020
- Study completionFeb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Mullti-center trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 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 klinische Forschungsabteilung
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02824614
- Sponsor's protocol ID
- Poly Gut
- Status last verified
- Mar 2020
- First submitted
- 27 Jun 2016
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Natural Sweeteners Erythritol and Xylitol on Gut Microbiota and Glucose Metabolism in Obese Volunteers
- ClinicalTrials.gov ID
- NCT02824614
- Acronym / sponsor ID
- Poly Gut
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Feb 2020 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 6 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. Animal studies showed an increase in gut Clostridium perfringens after xylitol intake; certainly a non-desirable effect. However, studies on effects of erythritol and xylitol on the human gut microbiota are lacking so far. In this trial, investigators aim to examine whether gut microbiota and glucose tolerance can be influenced by polyol intake in a non-diabetic but obese cohort.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Mullti-center trial
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –20 obese, non-diabetic candidates will serve as control-group. All assessments are carried out just as in the intervention groups. |
| E967-Xylitol | Active comparator | Dietary Supplement: E967-Xylitol20 obese, non-diabetic candidates will receive a daily dose of 24g of xylitol. |
| E968-Erythritol | Active comparator | Dietary Supplement: E968-Erythritol20 obese, non-diabetic candidates will receive a daily dose of 36g of erythritol. |
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 (13 listed)
- Known cardiovascular disease
- Diabetes mellitus
- Arterial Hypertension with medication
- Dyslipidaemia with medication
- Known chronic hepatic disease (NASH, hepatitis).
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-XylitolAlso: Xylitol | Dietary supplement | E967-Xylitol |
| E968-ErythritolAlso: Erythritol | Dietary supplement | E968-Erythritol |
Primary outcome
Glucose tolerance measured with oral glucose tolerance test
Time frame: change from baseline to 8 weeks after polyol intake
4 secondary outcomes
Human gut microbiota composition measured with metagenomic shotgun sequencing
Time frame: change from baseline to 8 weeks after polyol intake
Gut microbial-related metabolites in feces
Time frame: change from baseline to 8 weeks after polyol intake
Gastrointestinal tolerance assessed by questionnaire
Time frame: change from baseline to 8 weeks after polyol intake
Gut microbial-related metabolites in urine
Time frame: change from baseline to 8 weeks after polyol intake
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 20 Jul 2025.
- 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 klinische Forschungsabteilung
3 sites in 3 countries: 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 3 sites in 3 countries.
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 13 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 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Norway, Russia, 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?
Glucose tolerance measured with oral glucose tolerance test (time frame: change from baseline to 8 weeks after polyol intake). 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 20 Jul 2025.