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

NCT ID: NCT02821923

Last Updated: 2022-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-07

Study Completion Date

2022-03-10

Brief Summary

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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

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Control

no treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

E967-Xylitol

24g xylitol/d

Group Type ACTIVE_COMPARATOR

E967-Xylitol

Intervention Type DIETARY_SUPPLEMENT

24g xylitol/d

E968-Erythritol

36g erythritol/d

Group Type ACTIVE_COMPARATOR

E968-Erythritol

Intervention Type DIETARY_SUPPLEMENT

36g erythritol/d

Interventions

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E967-Xylitol

24g xylitol/d

Intervention Type DIETARY_SUPPLEMENT

E968-Erythritol

36g erythritol/d

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christoph Beglinger, MD

Role: STUDY_CHAIR

St. Claraspital Basel klinische Forschungsabteilung

Locations

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University Hospital

Basel, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 38618550 (View on PubMed)

Other Identifiers

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Poly Vasc

Identifier Type: -

Identifier Source: org_study_id

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