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

Study acronym: EryAdo
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Jul 2026 → Nov 2026
Primary endpoints removed 4 → 2 primary endpoints
See other at-risk trials from University Hospital, Basel, Switzerland

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary endpoint(s) modified Show 6 more changesShow less
    • Primary and study completion pushed from Jul 2026 to Nov 2026
    • Interventions modified
    • Trial arms changed: 8 → 7
    • Eligibility criteria shortened, about 189 words
    • Secondary endpoints: 28 to 26
    • Study description shortened, about 52 words
  2. Primary and study completion dates: Apr 2025 to Jul 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v10
  3. Primary endpoints: 3 to 4
    • Primary and study completion dates: Dec 2024 to Apr 2025
    • Eligibility criteria expanded, about 110 words
    • Study description expanded, about 25 words
    v9
  4. Primary endpoints: 2 to 3v8 Show 6 more changesShow less
    • Primary and study completion dates: Jul 2024 to Dec 2024
    • Interventions: Eryhtritol (Dietary Supplement), Fructose (Dietary Supplement), Glucose (Dietary Supplement), Sucrose (Dietary Supplement) to Eryhtritol (Dietary Supplement), Fructose (Dietary Supplement), Glucose (Dietary Supplement), Sucrose (Dietary Supplement), Water (Dietary…
    • Eligibility criteria expanded, about 129 words
    • Secondary endpoints: 22 to 28
    • Study description expanded, about 39 words
    • Study arms: 5 to 8
  5. Primary and study completion dates: Nov 2023 to Jul 2024v7
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  1. Primary endpoints: 1 to 2v6 Show 6 more changesShow less
    • Primary and study completion dates: Aug 2023 to Nov 2023
    • Interventions: Eryhtritol (Dietary Supplement), Sucrose (Dietary Supplement) to Eryhtritol (Dietary Supplement), Fructose (Dietary Supplement), Glucose (Dietary Supplement), Sucrose (Dietary Supplement)
    • Eligibility criteria expanded, about 113 words
    • Secondary endpoints: 20 to 22
    • Study description expanded, about 46 words
    • Study arms: 2 to 5
  2. Re-verified, no change to tracked fieldsv5
  3. Start date changed from estimate of Aug 2021 to Aug 18, 2021v4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v3
  5. Secondary endpoints: details revised at 1 of 20 entriesv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04966299
Lead Sponsor University Hospital, Basel, Switzerland
Conditions
(from sponsor)		 Insulin Resistance, Glucose Tolerance, Body Composition, Gastrointestinal Tolerance, Thrombocyte Aggregation, Blood p-Selectin, Blood Erythritol, Blood Xylitol
Related terms Insulin Resistance
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov