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

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Insulin Resistance; Body Composition; Glucose Tolerance; Gastrointestinal Tolerance; Thrombocyte Aggregation; Blood p-Selectin; Blood Erythritol; Blood Xylitol
• Intervention / Treatment: Dietary supplement: Sucrose; Dietary supplement: Glucose; Dietary supplement: Fructose; Dietary supplement: Eryhtritol; Dietary supplement: Xylitol; Dietary supplement: Water

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Canton of Basel-City
    • Basel, Canton of Basel-City, Switzerland, 4002
      • St. Claraspital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

EryAdo:

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.)

EryClot-Pilot:

3 participants

Inclusion criteria:

• Healthy participants 18-55 years upon inclusion
• Normal weight (BMI between 19.0-24.9 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 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

EryClot:

Inclusion criteria:

• Healthy participants 18-55 years upon inclusion
• Normal weight (BMI between 19.0-24.9 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 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 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.))

EryClot in vitro

Inclusion criteria:

• Healthy participants 18-55 years upon inclusion
• 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.
• 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.))

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sucrose; 15 participants receive 25g sucrose per day during 5 weeks	Dietary supplement: Sucrose; Sucrose-sweetened beverages twice a day (25g sucrose/day) with main meals during 5 weeks
Experimental: Erythritol; 15 participants receive 36g eryhtritol per day during 5 weeks	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; Other Names: E968-Erythritol
Experimental: EryClot-Pilot Erythritol; 3 participants receive 50g erythritol dissolved in 300mL water once during the visit	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; Other Names: E968-Erythritol
Active Comparator: EryClot-Pilot Glucose; 3 participants receive 75g glucose dissolved in 300mL water once during the visit	Dietary supplement: Glucose; Glucose 75g dissolved in 300mL water administered once per visit
Active Comparator: EryClot-Pilot Fructose; 3 participants receive 25g fructose dissolved in 300mL water once during the visit	Dietary supplement: Fructose; Fructose 25g dissolved in 300mL water administered once per visit
Experimental: EryClot Erythritol; 10 participants receive 50g erythritol dissolved in 300mL water once during the visit	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; Other Names: E968-Erythritol
Experimental: EryClot Xylitol; 10 participants receive 33.5g xylitol dissolved in 300mL water once during the visit	Dietary supplement: Xylitol; Xylitol 33.5g dissolved in 300mL water administered once per visit; Other Names: E967-Xylitol
Placebo Comparator: EryClot Water; 10 participants receive 300mL water once during the visit	Dietary supplement: Water; 300mL water administered once per visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insulin resistance	Insulin resistance as measured by the HOMA Index.	Change from baseline to 5 weeks after polyol/sucrose intake
EryClot-Pilot Thrombocyte aggregation	Thrombocyte aggregation after consumption of test solution measured with a blood sample	Blood samples at timepoint t= 0, 30, 60, 120, 180 minutes
EryClot Thrombocyte aggregation	Thrombocyte aggregation after consumption of test solution measured with a blood sample	Blood samples at timepoint t= -60, -1, 30, 60, 120, 180 minutes
EryClot in vitro: Platelet responsiveness in human platelet rich plasma	Aggregometry assay after addition of erythritol or xylitol in human platelet rich plasma	One single fasting blood sample at timepoint t = -10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose tolerance: Insulin	Insulin levels during OGTT	Change from baseline to 5 weeks after polyol/sucrose intake
Glucose tolerance: Glucose	Glucose levels during OGTT	Change from baseline to 5 weeks after polyol/sucrose intake
Glucose tolerance: C-Peptide	C-peptide levels during OGTT	Change from baseline to 5 weeks after polyol/sucrose intake
Glucose tolerance: Glucagon	Glucagon levels during OGTT	Change from baseline to 5 weeks after polyol/sucrose intake
Glucose tolerance: Fructosamin	Fructosamin levels	Change from baseline to 5 weeks after polyol/sucrose intake
Glucose tolerance: HbA1C	HbA1C levels	Change from baseline to 5 weeks after polyol/sucrose intake
Glucose tolerance: Continuous glucose monitoring average	Continuous glucose monitoring for average glucose levels	Change from baseline to 5 weeks after polyol/sucrose intake
Glucose tolerance: Continuous glucose monitoring glucose variability	Continuous glucose monitoring for glucose variability	Change from baseline to 5 weeks after polyol/sucrose intake
Glucose tolerance: Continuous glucose monitoring time within range	Continuous glucose monitoring for time within range	Change from baseline to 5 weeks after polyol/sucrose intake
Glucose absorption	Glucose absorption measured by 3-OMG concetrations during OGTT	Change from baseline to 5 weeks after polyol/sucrose intake
Metabolomics	Metabolomics in plasma, urine and stool samples, measured by 1H-NMR and Liquid Chromatography-Mass Spectrometry (LC-MS).	Change from baseline to 5 weeks after polyol/sucrose intake
Gut microbiota composition	The taxonomic and functional profiles of the gut microbiota (stool samples) assessed by metagenomic shotgun sequencing.	Change from baseline to 5 weeks after polyol/sucrose intake
Gastrointestinal hormones secretion: GLP-1	Secretion of GLP-1 during OGTT	Change from baseline to 5 weeks after polyol/sucrose intake
Gastrointestinal hormones secretion: PYY	Secretion of PYY during OGTT	Change from baseline to 5 weeks after polyol/sucrose intake
Gastrointestinal hormones secretion: Ghrelin	Secretion of Ghrelin during OGTT	Change from baseline to 5 weeks after polyol/sucrose intake
Gastrointestinal hormones secretion: CCK	Secretion of CCK during OGTT	Change from baseline to 5 weeks after polyol/sucrose intake
Food intake	Food intake assessed with self-reported food records	Change from baseline to 5 weeks after polyol/sucrose intake
Gastrointestinal tolerance	Gastrointestinal tolerance recorded by the "Gastrointestinal Symptoms Rating Scale" (GSRS), 15 items rated on 7 Point Likert-Scale, a higher score means a worse outcome. Maximum score: 90, Minimum score: 0	Change from baseline to 3 and 5 weeks after polyol/sucrose intake
Body composition: fat mass	Body composition assessed by mean of bioimpedance analysis: fat mass in kg	Change from baseline to 5 weeks after polyol/sucrose intake
Body composition: fat free mass	Body composition assessed by mean of bioimpedance analysis: fat free mass in kg	Change from baseline to 5 weeks after polyol/sucrose intake
EryClot-Pilot Blood p-Selectin concentrations	Blood p-Selectin concentrations after consumption of test solution	Blood samples at timepoint t= 0, 30, 60, 120, 180 minutes and 24, 48 hours
EryClot-Pilot Blood Erythritol concentrations	Blood Erythritol concentrations after consumption of test solution	Blood samples at timepoint t= 0, 30, 60, 120, 180 minutes and 24, 48 hours
EryClot blood p-selectin concentrations	Blood p-Selectin concentrations after consumption of test solution	Blood samples at timepoint t= -60, -1, 30, 60, 120, 180 minutes and 24, 48 hours
EryClot blood sVCAM1 concentrations	Blood sVCAM1 concentrations after consumption of test solution	Blood samples at timepoint t= -60, -1, 30, 60, 120, 180 minutes and 24, 48 hours
EryClot blood PF4 concentrations	Blood PF4 concentrations after consumption of test solution	Blood samples at timepoint t= -60, -1, 30, 60, 120, 180 minutes and 24, 48 hours
EryClot blood D-Dimers concentrations	Blood D-Dimers concentrations after consumption of test solution	Blood samples at timepoint t= -60, -1, 30, 60, 120, 180 minutes and 24, 48 hours
EryClot blood Erythritol concentrations	Blood erythritol concentrations after consumption of test solution	Blood samples at timepoint t= -60, -1, 30, 60, 120, 180 minutes and 24, 48 hours
EryClot blood Xylitol concentrations	Blood xylitol concentrations after consumption of test solution	Blood samples at timepoint t= -60, -1, 30, 60, 120, 180 minutes and 24, 48 hours

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Bettina K. Wölnerhanssen, PD. MD, St. Clara Research Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2021
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: May 25, 2021
• First Submitted That Met QC Criteria: July 6, 2021
• First Posted (Actual): July 19, 2021

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Glucose Metabolism Disorders; Hyperinsulinism; Nutritional and Metabolic Diseases; Insulin Resistance; Organic Chemicals; Carbohydrates; Inorganic Chemicals; Alcohols; Polysaccharides; Anions; Ions; Electrolytes; Hydroxides; Alkalies; Oxides; Oxygen Compounds; Disaccharides; Oligosaccharides; Sugars; Sugar Alcohols; Hexoses; Monosaccharides; Ketoses; Water; Glucose; Xylitol; Sucrose; Fructose
• Other Study ID Numbers: EryAdo

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No