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

NCT02821923 | Completed

• 1 other identifier: Poly Vasc
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Central arterial stiffness measured by sonography

  Change from baseline to 5 weeks after intake of polyol

Secondary Outcomes (1)

• Glucose tolerance measured by oral glucose tolerance test

  Change from baseline to 5 weeks after intake of polyol

Study Arms (3)

Control

NO INTERVENTION

no treatment

E967-Xylitol

ACTIVE COMPARATOR

24g xylitol/d

Dietary Supplement: E967-Xylitol

E968-Erythritol

ACTIVE COMPARATOR

36g erythritol/d

Dietary Supplement: E968-Erythritol

Interventions

E967-Xylitol DIETARY_SUPPLEMENT

24g xylitol/d

E967-Xylitol

E968-Erythritol DIETARY_SUPPLEMENT

36g erythritol/d

E968-Erythritol

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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
• 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).

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital

Basel, CH-4031, Switzerland

Location

Related Publications (1)

• Bordier V, Teysseire F, Drewe J, Madorin P, Bieri O, Schmidt-Trucksass A, Hanssen H, Beglinger C, Meyer-Gerspach AC, Wolnerhanssen BK. Effects of a 5-week intake of erythritol and xylitol on vascular function, abdominal fat and glucose tolerance in humans with obesity: a pilot trial. BMJ Nutr Prev Health. 2023 Nov 14;6(2):264-272. doi: 10.1136/bmjnph-2023-000764. eCollection 2023.

  PMID: 38618550 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christoph Beglinger, MD

  St. Claraspital Basel klinische Forschungsabteilung

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2016
• First Posted: July 4, 2016
• Study Start: November 7, 2016
• Primary Completion: March 10, 2022
• Study Completion: March 10, 2022
• Last Updated: May 18, 2022

Record last verified: 2022-05

Locations

CH (1)