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

University Hospital Basel

Status: Enrolling

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04966299

EryAdo

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 14 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.))

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 8 patient groups, including a placebo group

Sucrose

Active Comparator group

Description:

15 participants receive 25g sucrose per day during 5 weeks

Treatment:

Dietary Supplement: Sucrose

Erythritol

Experimental group

Description:

15 participants receive 36g eryhtritol per day during 5 weeks

Treatment:

Dietary Supplement: Eryhtritol

EryClot-Pilot Erythritol

Experimental group

Description:

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

Treatment:

Dietary Supplement: Eryhtritol

EryClot-Pilot Glucose

Active Comparator group

Description:

3 participants receive 75g glucose dissolved in 300mL water once during the visit

Treatment:

Dietary Supplement: Glucose

EryClot-Pilot Fructose

Active Comparator group

Description:

3 participants receive 25g fructose dissolved in 300mL water once during the visit

Treatment:

Dietary Supplement: Fructose

EryClot Erythritol

Experimental group

Description:

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

Treatment:

Dietary Supplement: Eryhtritol

EryClot Xylitol

Experimental group

Description:

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

Treatment:

Dietary Supplement: Xylitol

EryClot Water

Placebo Comparator group

Description:

10 participants receive 300mL water once during the visit

Treatment:

Dietary Supplement: Water