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

NCT04966299 | Active Not Recruiting

• 1 other identifier: EryAdo
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (28)

• Glucose tolerance: Insulin

  Change from baseline to 5 weeks after polyol/sucrose intake

• Glucose tolerance: Glucose

  Change from baseline to 5 weeks after polyol/sucrose intake

• Glucose tolerance: C-Peptide

  Change from baseline to 5 weeks after polyol/sucrose intake

• Glucose tolerance: Glucagon

  Change from baseline to 5 weeks after polyol/sucrose intake

• Glucose tolerance: Fructosamin

  Change from baseline to 5 weeks after polyol/sucrose intake

Study Arms (8)

Sucrose

ACTIVE COMPARATOR

15 participants receive 25g sucrose per day during 5 weeks

Dietary Supplement: Sucrose

Erythritol

EXPERIMENTAL

15 participants receive 36g eryhtritol per day during 5 weeks

Dietary Supplement: Eryhtritol

EryClot-Pilot Erythritol

EXPERIMENTAL

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

Dietary Supplement: Eryhtritol

EryClot-Pilot Glucose

ACTIVE COMPARATOR

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

Dietary Supplement: Glucose

EryClot-Pilot Fructose

ACTIVE COMPARATOR

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

Dietary Supplement: Fructose

EryClot Erythritol

EXPERIMENTAL

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

Dietary Supplement: Eryhtritol

EryClot Xylitol

EXPERIMENTAL

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

Dietary Supplement: Xylitol

EryClot Water

PLACEBO COMPARATOR

10 participants receive 300mL water once during the visit

Dietary Supplement: Water

Interventions

Eryhtritol DIETARY_SUPPLEMENT

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

Also known as: E968-Erythritol

EryClot Erythritol; EryClot-Pilot Erythritol; Erythritol

Sucrose DIETARY_SUPPLEMENT

Sucrose-sweetened beverages twice a day (25g sucrose/day) with main meals during 5 weeks

Sucrose

Glucose DIETARY_SUPPLEMENT

Glucose 75g dissolved in 300mL water administered once per visit

EryClot-Pilot Glucose

Fructose DIETARY_SUPPLEMENT

Fructose 25g dissolved in 300mL water administered once per visit

EryClot-Pilot Fructose

Xylitol DIETARY_SUPPLEMENT

Xylitol 33.5g dissolved in 300mL water administered once per visit

Also known as: E967-Xylitol

EryClot Xylitol

Water DIETARY_SUPPLEMENT

300mL water administered once per visit

EryClot Water

Eligibility Criteria

• Age: 14 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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:
• participants
• Normal weight (BMI between 19.0-24.9 kg/m2)

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

St. Claraspital

Basel, Canton of Basel-City, 4002, Switzerland

Location

MeSH Terms

Conditions

Insulin Resistance

Interventions

Sucrose; Glucose; Fructose; Xylitol; Water

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars; Hexoses; Monosaccharides; Ketoses; Sugar Alcohols; Alcohols; Organic Chemicals; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Bettina K. Wölnerhanssen, PD. MD

  St. Clara Research Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: EryClot-Pilot: This trial is a randomized, double-blind, crossover trial. The project set-up is single-center, national. In total, 3 volunteers will be enrolled. There will be 3 study arms. EryClot This trial is a randomized single-blind, crossover trial. The project setup is single-center national. In total 10 volunteers will be enrolled. There will be 3 study arms. EryClot in vitro This trial is an in vitro trial using human blood samples. The project setup is single-center national. In total blood samples from 12 volunteers will be collected.

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: July 19, 2021
• Study Start: August 18, 2021
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)