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NCT04966299

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

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).

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

Start Date

2021-08-18

Completion Date

2025-04

Last Updated

2025-01-31

Healthy Volunteers

Yes

Conditions

Insulin Resistance Glucose Tolerance Body Composition Gastrointestinal Tolerance Thrombocyte Aggregation Blood p-Selectin Blood Erythritol Blood Xylitol

Interventions

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

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.))

Locations (1)

St. Claraspital

Basel, Canton of Basel-City, Switzerland

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (1)