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

NCT ID: NCT02824614

Last Updated: 2025-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2020-02-29

Brief Summary

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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

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Mullti-center trial
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

E967-Xylitol

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

Group Type ACTIVE_COMPARATOR

E967-Xylitol

Intervention Type DIETARY_SUPPLEMENT

E968-Erythritol

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

Group Type ACTIVE_COMPARATOR

E968-Erythritol

Intervention Type DIETARY_SUPPLEMENT

Interventions

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E967-Xylitol

Intervention Type DIETARY_SUPPLEMENT

E968-Erythritol

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Xylitol Erythritol

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christoph Beglinger, MD

Role: STUDY_CHAIR

St. Claraspital klinische Forschungsabteilung

Locations

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Department of Endocrinology, Morbid Obesity and Preventive Medicine, Oslo University Hospital

Oslo, , Norway

Site Status

Endoscopic and Minimally Invasive Surgery Clinic of Stavropol State Medical University

Stavropol, , Russia

Site Status

St Claraspital

Basel, , Switzerland

Site Status

Countries

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Norway Russia Switzerland

Other Identifiers

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Poly Gut

Identifier Type: -

Identifier Source: org_study_id

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