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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02821923
Recruitment Status : Recruiting
First Posted : July 4, 2016
Last Update Posted : November 15, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: E967-Xylitol Dietary Supplement: E968-Erythritol Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of the Natural Sweeteners Erythritol and Xylitol on Vascular Function in Obese Volunteers: A Pilot Study
Study Start Date : June 2016
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Xylitol

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




Primary Outcome Measures :
  1. Central arterial stiffness measured by sonography [ Time Frame: Change from baseline to 5 weeks after intake of polyol ]

Secondary Outcome Measures :
  1. Glucose tolerance measured by oral glucose tolerance test [ Time Frame: Change from baseline to 5 weeks after intake of polyol ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02821923


Contacts
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Contact: Bettina Wölnerhanssen, MD bettina.woelnerhanssen@unibas.ch

Locations
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Switzerland
University Hospital Recruiting
Basel, Switzerland, CH-4031
Contact: Bettina K Woelnerhanssen, MD       bettina.woelnerhanssen@unibas.ch   
Principal Investigator: Christoph Beglinger, MD         
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Study Chair: Christoph Beglinger, MD St. Claraspital Basel klinische Forschungsabteilung
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02821923    
Other Study ID Numbers: Poly Vasc
First Posted: July 4, 2016    Key Record Dates
Last Update Posted: November 15, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Erythritol
Vasodilator Agents