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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02821923
• Other study ID #: Poly Vasc
• Status: Completed
• Phase: N/A
• Start date: November 7, 2016
• Est. completion date: March 10, 2022

Study information

• Verified date: May 2022
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: March 10, 2022
• Est. primary completion date: March 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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).

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• E967-Xylitol
24g xylitol/d
• E968-Erythritol
36g erythritol/d

Locations

Country	Name	City	State
Switzerland	University Hospital	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Central arterial stiffness measured by sonography		Change from baseline to 5 weeks after intake of polyol
Secondary	Glucose tolerance measured by oral glucose tolerance test		Change from baseline to 5 weeks after intake of polyol