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CompletedNCT02824614Updated Jul 20, 2025

Effect of the Natural Sweeteners Erythritol and Xylitol on Gut Microbiota and Glucose Metabolism in Obese Volunteers

An interventional study of E967-Xylitol and E968-Erythritol in Obesity, sponsored by University Hospital, Basel, Switzerland. Completed at 3 sites in 3 countries. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2025-07-20.

Sponsored by University Hospital, Basel, Switzerland · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
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Study 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. 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.

02

Conditions studied

  • Obesity

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03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 64 is below the median of 78 across 4,878 interventional studies indexed under Obesity.

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Lead sponsor

University Hospital, Basel, Switzerland is the lead sponsor of 968 studies on the registry; 191 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Obese volunteers (BMI > 30kg/m2)
  • Aged 18- max. 55 years
  • Otherwise healthy.

Exclusion criteria

Exclusion Criteria:

  • Known cardiovascular disease
  • Diabetes mellitus
  • Arterial Hypertension with medication
  • Dyslipidaemia with medication
  • Known chronic hepatic disease (NASH, hepatitis).
  • Known renal disease: kidney failure
  • 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).
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
64 participants (actual)

Study arms

  • No intervention
    Control

    20 obese, non-diabetic candidates will serve as control-group. All assessments are carried out just as in the intervention groups.

  • Active comparator
    E967-Xylitol

    20 obese, non-diabetic candidates will receive a daily dose of 24g of xylitol.

    Dietary Supplement: E967-Xylitol

  • Active comparator
    E968-Erythritol

    20 obese, non-diabetic candidates will receive a daily dose of 36g of erythritol.

    Dietary Supplement: E968-Erythritol

Interventions

  • Dietary supplementE967-Xylitol

    Also known as: Xylitol

  • Dietary supplementE968-Erythritol

    Also known as: Erythritol

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What researchers measure

Primary outcomes

  1. Glucose tolerance measured with oral glucose tolerance test

    Time frame: change from baseline to 8 weeks after polyol intake

Secondary outcomes

  1. Human gut microbiota composition measured with metagenomic shotgun sequencing

    Time frame: change from baseline to 8 weeks after polyol intake

  2. 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

    Time frame: change from baseline to 8 weeks after polyol intake

  3. Gastrointestinal tolerance assessed by questionnaire

    Gastrointestinal Symptoms Rating Scale (Svedlund et al)

    Time frame: change from baseline to 8 weeks after polyol intake

  4. 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

    Time frame: change from baseline to 8 weeks after polyol intake

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Study locations

3 sites
  • Department of Endocrinology, Morbid Obesity and Preventive Medicine, Oslo University Hospital
    Oslo, Norway
  • Endoscopic and Minimally Invasive Surgery Clinic of Stavropol State Medical University
    Stavropol, Russia
  • St Claraspital
    Basel, CH-4016, Switzerland
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02824614
Lead sponsor
University Hospital, Basel, Switzerland
Responsible party
Sponsor
First posted
Jul 6, 2016
Start date
Jun 2016
Primary completion
Feb 2020
Completion
Feb 2020
Last update
Jul 20, 2025

Study contacts

Christoph Beglinger, MD
study chair · St. Claraspital klinische Forschungsabteilung

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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