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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02824614
• Other study ID #: Poly Gut
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: February 2020

Study information

• Verified date: March 2020
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: February 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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).

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• E967-Xylitol

• E968-Erythritol

Locations

Country	Name	City	State
Switzerland	St Claraspital	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose tolerance measured with oral glucose tolerance test		change from baseline to 8 weeks after polyol intake
Secondary	Human gut microbiota composition measured with metagenomic shotgun sequencing		change from baseline to 8 weeks after polyol intake
Secondary	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	change from baseline to 8 weeks after polyol intake
Secondary	Gastrointestinal tolerance assessed by questionnaire	Gastrointestinal Symptoms Rating Scale (Svedlund et al)	change from baseline to 8 weeks after polyol intake
Secondary	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	change from baseline to 8 weeks after polyol intake