Effect of the Natural Sweeteners Erythritol and Xylitol on Vascular Function in Obese Volunteers

Effect of the Natural Sweeteners Erythritol and Xylitol on Vascular Function in Obese Volunteers: A Pilot Study

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. A pilot study recently undertaken in the US (Flint N, 2014) has shown that diabetics profit from a daily intake of erythritol, as this natural sweetener enhances the elasticity of the blood vessels. In this trial, investigators aim to examine whether this effect can be found in a non-diabetic but obese cohort, and whether also xylitol improves vascular function.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, CH-4031
    • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 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
• Smoking and drug abuse
• Arterial hypertension with antihypertensive treatment
• Dyslipidaemia with statin therapy
• Known chronic hepatic disease (NASH, hepatitis).
• Known renal disease: kidney failure
• Pregnancy
• 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: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; no treatment
Active Comparator: E967-Xylitol; 24g xylitol/d	Dietary supplement: E967-Xylitol; 24g xylitol/d
Active Comparator: E968-Erythritol; 36g erythritol/d	Dietary supplement: E968-Erythritol; 36g erythritol/d

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Central arterial stiffness measured by sonography	Change from baseline to 5 weeks after intake of polyol

Secondary Outcome Measures

Outcome Measure	Time Frame
Glucose tolerance measured by oral glucose tolerance test	Change from baseline to 5 weeks after intake of polyol

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2016
• Primary Completion (Actual): March 10, 2022
• Study Completion (Actual): March 10, 2022

Study Registration Dates

• First Submitted: June 27, 2016
• First Submitted That Met QC Criteria: June 29, 2016
• First Posted (Estimate): July 4, 2016

Study Record Updates

• Last Update Posted (Actual): May 18, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

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

Plan for Individual participant data (IPD)

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