Trials / Recruiting

RecruitingNCT04966299

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

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

Status: Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 30 (estimated)

Sponsor: University Hospital, Basel, Switzerland · Academic / Other
Sex: All
Age: 14 Years – 55 Years
Healthy volunteers: Accepted

Summary

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. EryClot-Pilot: Erythritol is also produced by the human body and possibly elevated erythritol levels in the blood are an indication of an increased risk of cardiovascular disease, obesity or diabetes in the future. In a recently published study, a possible effect of erythritol on blood clotting function was described. In this in vitro experiment, increased blood clotting was observed when erythritol was added to clotting cells (platelets) in the test tube. Studies in humans on blood coagulation after administration of erythritol are missing so far. With a pilot study, the investigators study whether erythritol is detectable in the blood after administration of glucose and fructose. Furthermore, the erythritol level in the blood and a possible effect on the blood coagulation function after administration of erythritol will be investigated. These preliminary tests serve to clarify the data situation so that further studies can be based on them. The preliminary results of the EryClot\_Pilot study indicate that there appears to be no measurable effect of erythritol on thrombocyte aggregation. This implicates 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 administration on more parameters of blood coagulation as well as in more subjects. Due to a study published in June 2024, there appears the need to investigate the effects of xylitol on blood clotting function as well. EryClot in vitro: In addition to the human EryClot study, we will conduct in vitro experiments (aggregometry assay after addition of erythritol or xylitol in human platelet rich plasma).

Detailed description

This trial aims to assess the effects of the daily intake of an erythritol-sweetened beverage over 5 weeks on insulin resistance, glucose tolerance and metabolism as well as on gut microbiota. Moreover, this study will also assess the effect of the above-mentioned intervention on food intake, body composition and gastrointestinal tolerance in this population. EryClot-Pilot: The aim of this pilot study is to investigate whether erythritol is detectable in the blood after administration of glucose and fructose. Furthermore, the erythritol level in the blood and a possible effect on the blood clotting function after administration of erythritol will be investigated. EryClot: The aim of this study is to investigate the erythritol level in blood after administration of erythritol and a possible effect on blood clotting function. Additionally, a possible effect of xylitol on blood clotting function will be investigated. EryClot in vitro: The aim of this study is to investigate the platelet responsiveness in vitro in human plasma after addition of erythritol and xylitol.

Conditions

Interventions

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

Timeline

Start date: 2021-08-18
Primary completion: 2025-04-01
Completion: 2025-04-01
First posted: 2021-07-19
Last updated: 2025-01-31

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT04966299. Inclusion in this directory is not an endorsement.