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

Insulin Resistance Clinical Trial

— EryAdo  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04966299
• Other study ID #: EryAdo
• Status: Recruiting
• Phase: N/A
• Start date: August 18, 2021
• Est. completion date: July 2024

Study information

• Verified date: March 2024
• Source: University Hospital, Basel, Switzerland
• Contact: Bettina K. Wölnerhanssen, PD. MD
• Phone: + 41 61 685 86 32
• Email: bettina.woelnerhanssen[@]claraspital.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Composition
• Gastrointestinal Tolerance
• Glucose Tolerance
• Insulin Resistance

Intervention

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
• Sucrose
Sucrose-sweetened beverages twice a day (25g sucrose/day) with main meals during 5 weeks
• Glucose
Glucose 75g dissolved in 300mL water administered once per visit
• Fructose
Fructose 25g dissolved in 300mL water administered once per visit

Locations

Country	Name	City	State
Switzerland	St. Claraspital	Basel	Basel-Stadt

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin resistance	Insulin resistance as measured by the HOMA Index.	Change from baseline to 5 weeks after polyol/sucrose intake
Primary	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
Secondary	Glucose tolerance: Insulin	Insulin levels during OGTT	Change from baseline to 5 weeks after polyol/sucrose intake
Secondary	Glucose tolerance: Glucose	Glucose levels during OGTT	Change from baseline to 5 weeks after polyol/sucrose intake
Secondary	Glucose tolerance: C-Peptide	C-peptide levels during OGTT	Change from baseline to 5 weeks after polyol/sucrose intake
Secondary	Glucose tolerance: Glucagon	Glucagon levels during OGTT	Change from baseline to 5 weeks after polyol/sucrose intake
Secondary	Glucose tolerance: Fructosamin	Fructosamin levels	Change from baseline to 5 weeks after polyol/sucrose intake
Secondary	Glucose tolerance: HbA1C	HbA1C levels	Change from baseline to 5 weeks after polyol/sucrose intake
Secondary	Glucose tolerance: Continuous glucose monitoring average	Continuous glucose monitoring for average glucose levels	Change from baseline to 5 weeks after polyol/sucrose intake
Secondary	Glucose tolerance: Continuous glucose monitoring glucose variability	Continuous glucose monitoring for glucose variability	Change from baseline to 5 weeks after polyol/sucrose intake
Secondary	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
Secondary	Glucose absorption	Glucose absorption measured by 3-OMG concetrations during OGTT	Change from baseline to 5 weeks after polyol/sucrose intake
Secondary	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
Secondary	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
Secondary	Gastrointestinal hormones secretion: GLP-1	Secretion of GLP-1 during OGTT	Change from baseline to 5 weeks after polyol/sucrose intake
Secondary	Gastrointestinal hormones secretion: PYY	Secretion of PYY during OGTT	Change from baseline to 5 weeks after polyol/sucrose intake
Secondary	Gastrointestinal hormones secretion: Ghrelin	Secretion of Ghrelin during OGTT	Change from baseline to 5 weeks after polyol/sucrose intake
Secondary	Gastrointestinal hormones secretion: CCK	Secretion of CCK during OGTT	Change from baseline to 5 weeks after polyol/sucrose intake
Secondary	Food intake	Food intake assessed with self-reported food records	Change from baseline to 5 weeks after polyol/sucrose intake
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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