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

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ClinicalTrials.gov Identifier: NCT02824614
Recruitment Status : Completed
First Posted : July 6, 2016
Last Update Posted : March 26, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief 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.

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: E967-Xylitol Dietary Supplement: E968-Erythritol Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Effect of the Natural Sweeteners Erythritol and Xylitol on Gut Microbiota and Glucose Metabolism in Obese Volunteers
Actual Study Start Date : June 2016
Actual Primary Completion Date : February 2020
Actual Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Xylitol

Arm Intervention/treatment
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
Other Name: Xylitol

Active Comparator: E968-Erythritol
20 obese, non-diabetic candidates will receive a daily dose of 36g of erythritol.
Dietary Supplement: E968-Erythritol
Other Name: Erythritol




Primary Outcome Measures :
  1. Glucose tolerance measured with oral glucose tolerance test [ Time Frame: change from baseline to 8 weeks after polyol intake ]

Secondary Outcome Measures :
  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 [ Time Frame: change from baseline to 8 weeks after polyol intake ]
    Metabolomic analysis of the bacterial metabolites present in the feces by combining nuclear magnetic resonance (1H-NMR) and mass spectrometry

  3. Gastrointestinal tolerance assessed by questionnaire [ Time Frame: change from baseline to 8 weeks after polyol intake ]
    Gastrointestinal Symptoms Rating Scale (Svedlund et al)

  4. Gut microbial-related metabolites in urine [ Time Frame: change from baseline to 8 weeks after polyol intake ]
    Metabolomic analysis of the bacterial metabolites present in the urine by combining nuclear magnetic resonance (1H-NMR) and mass spectrometry



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02824614


Locations
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Switzerland
St Claraspital
Basel, Switzerland, CH-4016
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Study Chair: Christoph Beglinger, MD St. Claraspital klinische Forschungsabteilung

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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02824614    
Other Study ID Numbers: Poly Gut
First Posted: July 6, 2016    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Erythritol
Vasodilator Agents