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Completed

NCT Number: NCT02821923

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

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.

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Key information

Conditions

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

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Basel, CH-4031, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

E967-Xylitol

Dietary Supplement

24g xylitol/d

E968-Erythritol

Dietary Supplement

36g erythritol/d

Primary outcomes

  1. Central arterial stiffness measured by sonography

    Time frame: Change from baseline to 5 weeks after intake of polyol

Secondary outcomes

  1. Glucose tolerance measured by oral glucose tolerance test

    Time frame: Change from baseline to 5 weeks after intake of polyol

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Jul 4, 2016
Registry last updated
May 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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