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

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Dietary Supplement: E967-Xylitol; Dietary Supplement: E968-Erythritol

• Registration Number: NCT02821923
• Lead Sponsor: University Hospital, Basel, Switzerland

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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-27
• Study First Submitted QC: 2016-06-29
• Study First Posted: 2016-07-04
• Study Start: 2016-11-07
• Primary Completion: 2022-03-10
• Study Completion: 2022-03-10
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-17
• Last Update Posted: 2022-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
E967-Xylitol	E967-Xylitol	24g xylitol/d
E968-Erythritol	E968-Erythritol	36g erythritol/d

Primary Outcome Measures

Name	Time	Method
Central arterial stiffness measured by sonography	Change from baseline to 5 weeks after intake of polyol

Secondary Outcome Measures

Name	Time	Method
Glucose tolerance measured by oral glucose tolerance test	Change from baseline to 5 weeks after intake of polyol

Trial Locations

Locations (1)

University Hospital; 🇨🇭 Basel, Switzerland