NCT02824614

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable obesity

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

June 27, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 6, 2016

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

July 20, 2025

Status Verified

March 1, 2020

Enrollment Period

3.7 years

First QC Date

June 27, 2016

Last Update Submit

July 16, 2025

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Glucose tolerance measured with oral glucose tolerance test

    change from baseline to 8 weeks after polyol intake

Secondary Outcomes (4)

  • Human gut microbiota composition measured with metagenomic shotgun sequencing

    change from baseline to 8 weeks after polyol intake

  • Gut microbial-related metabolites in feces

    change from baseline to 8 weeks after polyol intake

  • Gastrointestinal tolerance assessed by questionnaire

    change from baseline to 8 weeks after polyol intake

  • Gut microbial-related metabolites in urine

    change from baseline to 8 weeks after polyol intake

Study Arms (3)

Control

NO INTERVENTION

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

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

Dietary Supplement: E967-Xylitol

E968-Erythritol

ACTIVE COMPARATOR

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

Dietary Supplement: E968-Erythritol

Interventions

E967-XylitolDIETARY_SUPPLEMENT
Also known as: Xylitol
E967-Xylitol
E968-ErythritolDIETARY_SUPPLEMENT
Also known as: Erythritol
E968-Erythritol

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Obese volunteers (BMI \> 30kg/m2)
  • Aged 18- max. 55 years
  • Otherwise healthy.

You may not qualify if:

  • 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 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

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

Oslo, Norway

Location

Endoscopic and Minimally Invasive Surgery Clinic of Stavropol State Medical University

Stavropol, Russia

Location

St Claraspital

Basel, CH-4016, Switzerland

Location

MeSH Terms

Conditions

Obesity

Interventions

XylitolErythritol

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sugar AlcoholsAlcoholsOrganic ChemicalsCarbohydrates

Study Officials

  • Christoph Beglinger, MD

    St. Claraspital klinische Forschungsabteilung

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Mullti-center trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2016

First Posted

July 6, 2016

Study Start

June 1, 2016

Primary Completion

February 1, 2020

Study Completion

February 1, 2020

Last Updated

July 20, 2025

Record last verified: 2020-03

Locations

CH(1)NO(1)RU(1)