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Active Not Recruiting
NCT04966299
Effect of Daily Erythritol Versus Sucrose Intake Over 5 Weeks on Glucose Tolerance in Adolescents
Conditions: Insulin Resistance, Glucose Tolerance, Body Composition, Gastrointestinal Tolerance, Thrombocyte Aggregation, Blood p-Selectin, Blood Erythritol, Blood Xylitol
Sex: All
Ages: 14 Years – 55 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 30
Sponsor: University Hospital, Basel, Switzerland
Location: St. Claraspital Basel Canton of Basel-City
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.
Eligibility Criteria
Part A EryAdo Trial:
Inclusion Criteria:
* Healthy adolescents
* Aged 14-18 years
* Normal weight (BMI between 15th and 85th percentile for age and gender)
* Minimum weight of 45kg
* Regular sugar consumption \>25g/d
Exclusion Criteria:
* Severe acute or chronic diseases
* Pregnancy
* Regular intake of prebiotics
* Regular intake of probiotics
* Regular intake of pro-/prebiotic foods
* Antibiotics cure within 3 months preceding the present study
* Substance abuse
* Inability to follow procedures due to psychological disorders or insufficient knowledge of project language (German)
* Participation in another study with investigational drug within the 30 days preceding and during the present study.
* Pre-existing regular consumption (\>1/week) of erythritol
* Fructose-intolerance
* Pre-existing diet (vegetarian, vegan, gluten-free, lactose-free, caloric restriction, etc.)
Part B EryClot Trial:
Inclusion criteria:
* Healthy participants 18-55 years upon inclusion
* Normal weight (BMI between 19.0-24.9 kg/m2; for in vitro: BMI \< 30 kg/m2)
* Informed consent signed by participant
Exclusion criteria:
* Severe acute or chronic diseases
* Pregnancy: although no contraindication, pregnancy might influence metabolic state. Female adolescents who are pregnant or have the intention to become pregnant during the course of the study are excluded. In female participants a urine pregnancy test is carried out upon screening
* Substance abuse, smoking
* Inability to follow procedures due to psychological disorders
* Participation in another study with investigational drug within the 30 days preceding and during the present study.
* Pre-existing regular consumption (\>1/week) of erythritol or xylitol
* Pre-existing impairment of blood coagulation/thrombocyte function (e.g., hereditary, regular intake of anti-coagulant agents (e.g., NSAIDs, heparin, warfarin, etc.))
Source: ClinicalTrials.gov (NCT04966299). StuddyBuddy aggregates publicly available trial information.