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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 6 April 2020
Main ID:  NCT02824614
Date of registration: 27/06/2016
Prospective Registration: Yes
Primary sponsor: University Hospital, Basel, Switzerland
Public title: Effect of the Natural Sweeteners Erythritol and Xylitol on Gut Microbiota and Glucose Metabolism in Obese Volunteers
Scientific title: Effect of the Natural Sweeteners Erythritol and Xylitol on Gut Microbiota and Glucose Metabolism in Obese Volunteers
Date of first enrolment: June 2016
Target sample size: 64
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02824614
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: Single (Participant).  
Phase:  N/A
Countries of recruitment
Switzerland
Contacts
Name:     Christoph Beglinger, MD
Address: 
Telephone:
Email:
Affiliation:  St. Claraspital klinische Forschungsabteilung
Key inclusion & exclusion 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).



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All
Health Condition(s) or Problem(s) studied
Obesity
Intervention(s)
Dietary Supplement: E967-Xylitol
Dietary Supplement: E968-Erythritol
Primary Outcome(s)
Glucose tolerance measured with oral glucose tolerance test [Time Frame: change from baseline to 8 weeks after polyol intake]
Secondary Outcome(s)
Gastrointestinal tolerance assessed by questionnaire [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]
Gut microbial-related metabolites in urine [Time Frame: change from baseline to 8 weeks after polyol intake]
Human gut microbiota composition measured with metagenomic shotgun sequencing [Time Frame: change from baseline to 8 weeks after polyol intake]
Secondary ID(s)
Poly Gut
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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