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

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Dietary Supplement: E968-Erythritol; Dietary Supplement: E967-Xylitol

• Registration Number: NCT02824614
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-27
• Study First Submitted QC: 2016-07-01
• Study First Posted: 2016-07-06
• Primary Completion: 2020-02
• Study Completion: 2020-02
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-25
• Last Update Posted: 2020-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
E968-Erythritol	E968-Erythritol	20 obese, non-diabetic candidates will receive a daily dose of 36g of erythritol.
E967-Xylitol	E967-Xylitol	20 obese, non-diabetic candidates will receive a daily dose of 24g of xylitol.

Primary Outcome Measures

Name	Time	Method
Glucose tolerance measured with oral glucose tolerance test	change from baseline to 8 weeks after polyol intake

Secondary Outcome Measures

Name	Time	Method
Human gut microbiota composition measured with metagenomic shotgun sequencing	change from baseline to 8 weeks after polyol intake
Gastrointestinal tolerance assessed by questionnaire	change from baseline to 8 weeks after polyol intake	Gastrointestinal Symptoms Rating Scale (Svedlund et al)
Gut microbial-related metabolites in urine	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
Gut microbial-related metabolites in feces	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

Trial Locations

Locations (1)

St Claraspital; 🇨🇭 Basel, Switzerland