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ACTIVE NOT RECRUITING
NCT04966299
NA

Effect of Daily Erythritol Versus Sucrose Intake Over 5 Weeks on Glucose Tolerance in Adolescents

Sponsor: University Hospital, Basel, Switzerland

View on ClinicalTrials.gov

Summary

This trial is divided into different parts: Part A the EryAdo trial and Part B the EryClot trial. Part A EryAdo Trial: Childhood and adolescence are crucial periods for prevention of obesity, as obese children are five times more likely to be obese at adulthood than lean children. To this purpose, sugar consumption should be reduced. The sugar alcohol erythritol is increasingly popular as sugar substitute in the food industry and is also recommended to diabetic patients. The substance is freely available. Recent acute studies show that erythritol has a positive influence on satiation and gastric emptying without affecting insulin and plasma glucose. In this trial, the investigators aim to assess the effect of a chronic intake of erythritol versus sucrose on insulin resistance in healthy adolescents. Part B EryClot Trial: In recently published studies, a prothrombotic effect of erythritol and xylitol was described. Therefore, within a pilot study the investigators examined whether erythritol is detectable in the blood after administration of erythritol and conventional sweeteners (glucose and fructose). Also the effect on blood clotting was investigated. These preliminary tests served to clarify the data situation so that further studies can be based on them. The preliminary results of the pilot study indicated that there appears to be no measurable effect of erythritol on thrombocyte aggregation. This implicated that there is a discrepancy between our results and the results reported in a recent published study. This is why we need to assess the effects of erythritol in more detail (thrombocyte aggregation, and markers of platelet activation, endothelial activation and coagulation) in more subjects. Due to a study published in 2024 describing similar prothrombotic effects for xylitol, this substance needs to be investigated as well. Thus, the participants will receive erythritol, xylitol, or water in a randomized order. In addition to the EryClot ex vivo experiments, we will conduct in vitro experiments incubating platelet-rich plasma from healthy donors with increasing concentrations erythritol or xylitol followed by measurement of platelet aggregation by aggreegometry assay.

Official title: Effect of Daily Erythritol Versus Sucrose Intake Over 5 Weeks on Glucose Tolerance in Adolescents: a Pilot Trial

Key Details

Gender

All

Age Range

14 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2021-08-18

Completion Date

2026-11

Last Updated

2026-09-30

Healthy Volunteers

Yes

Interventions

DIETARY_SUPPLEMENT

Erythritol

EryAdo: Erythritol-sweetened beverages twice a day (36g erythritol/day) with main meals during 5 weeks EryClot: Erythritol 50g dissolved in 300mL water administered once per visit

DIETARY_SUPPLEMENT

Sucrose

Sucrose-sweetened beverages twice a day (25g sucrose/day) with main meals during 5 weeks

DIETARY_SUPPLEMENT

Glucose

Glucose 75g dissolved in 300mL water administered once per visit

DIETARY_SUPPLEMENT

Fructose

Fructose 25g dissolved in 300mL water administered once per visit

DIETARY_SUPPLEMENT

Xylitol

Xylitol 33.5g dissolved in 300mL water administered once per visit

DIETARY_SUPPLEMENT

Water

300mL water administered once per visit

Locations (1)

St. Claraspital

Basel, Canton of Basel-City, Switzerland