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

University Hospital Basel

Status: Completed

Conditions: Obesity

Treatments: Dietary Supplement: E968-Erythritol; Dietary Supplement: E967-Xylitol

Study type: Interventional

Funder types: Other

Identifiers

NCT02824614

Poly Gut

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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64 participants in 3 patient groups

Control

No Intervention group

Description:

20 obese, non-diabetic candidates will serve as control-group. All assessments are carried out just as in the intervention groups.

E967-Xylitol

Active Comparator group

Description:

20 obese, non-diabetic candidates will receive a daily dose of 24g of xylitol.

Treatment:

Dietary Supplement: E967-Xylitol

E968-Erythritol

Active Comparator group

Description:

20 obese, non-diabetic candidates will receive a daily dose of 36g of erythritol.

Treatment:

Dietary Supplement: E968-Erythritol