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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02824614
• Date of registration: 27/06/2016
• Prospective Registration: No
• 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
• 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: E968-Erythritol

Dietary Supplement: E967-Xylitol

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]

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 urine [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