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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Dietary supplement: E967-Xylitol; Dietary supplement: E968-Erythritol

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, CH-4016
    • St Claraspital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: Xylitol
Active Comparator: E968-Erythritol; 20 obese, non-diabetic candidates will receive a daily dose of 36g of erythritol.	Dietary supplement: E968-Erythritol; Other Names: Erythritol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Glucose tolerance measured with oral glucose tolerance test	change from baseline to 8 weeks after polyol intake

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Human gut microbiota composition measured with metagenomic shotgun sequencing		change from baseline to 8 weeks after polyol intake
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
Gastrointestinal tolerance assessed by questionnaire	Gastrointestinal Symptoms Rating Scale (Svedlund et al)	change from baseline to 8 weeks after polyol intake
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

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Study Chair: Christoph Beglinger, MD, St. Claraspital klinische Forschungsabteilung

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): February 1, 2020
• Study Completion (Actual): February 1, 2020

Study Registration Dates

• First Submitted: June 27, 2016
• First Submitted That Met QC Criteria: July 1, 2016
• First Posted (Estimate): July 6, 2016

Study Record Updates

• Last Update Posted (Actual): March 26, 2020
• Last Update Submitted That Met QC Criteria: March 25, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vasodilator Agents; Erythritol
• Other Study ID Numbers: Poly Gut

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided