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

University Hospital Basel

Status: Active, not recruiting

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

Treatments: Dietary Supplement: Water; Dietary Supplement: Fructose; Dietary Supplement: Erythritol; Dietary Supplement: Glucose; Dietary Supplement: Sucrose; Dietary Supplement: Xylitol

Study type: Interventional

Funder types: Other

Identifiers

NCT04966299

EryAdo

Details and patient eligibility

About

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.

Full description

Part A EryAdo Trial:

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.

Part B EryClot Trial:

The aim of this study is to investigate whether erythritol is detectable in the blood after administration of glucose and fructose, whether there is an effect of erythritol or xylitol on blood clotting and to investigate the platelet responsiveness in vitro in human plasma after addition of erythritol and xylitol.

Enrollment: 30 estimated patients

Sex: All

Ages: 14 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.))

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 7 patient groups, including a placebo group

EryAdo: Sucrose

Active Comparator group

Description:

Participants receive 25g sucrose per day during 5 weeks

Treatment:

Dietary Supplement: Sucrose

EryAdo: Erythritol

Experimental group

Description:

Participants receive 36g erythritol per day during 5 weeks

Treatment:

Dietary Supplement: Erythritol

EryClot Glucose

Active Comparator group

Description:

Participants receive 75g glucose dissolved in 300mL water once during the visit (only in the pilot study)

Treatment:

Dietary Supplement: Glucose

EryClot Fructose

Active Comparator group

Description:

Participants receive 25g fructose dissolved in 300mL water once during the visit (only in the pilot study)

Treatment:

Dietary Supplement: Fructose

EryClot Erythritol

Experimental group

Description:

Participants receive 50g erythritol dissolved in 300mL water once during the visit

Treatment:

Dietary Supplement: Erythritol

EryClot Xylitol

Experimental group

Description:

Participants receive 33.5g xylitol dissolved in 300mL water once during the visit

Treatment:

Dietary Supplement: Xylitol

EryClot Water

Placebo Comparator group

Description:

Participants receive 300mL water once during the visit

Treatment:

Dietary Supplement: Water