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

Launched by UNIVERSITY HOSPITAL, BASEL, SWITZERLAND · Jul 6, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effects of two sweeteners: erythritol and sucrose (table sugar) on how the body handles sugar in healthy adolescents aged 14 to 18. The goal is to see if using erythritol instead of regular sugar can help improve insulin resistance, which is when the body doesn’t use insulin effectively, potentially leading to conditions like obesity and diabetes. Participants need to be of normal weight and consume more than 25 grams of sugar daily, but they cannot have any serious health issues or be pregnant.

If eligible and participating in the trial, adolescents can expect to consume either erythritol or sucrose daily for five weeks while their blood sugar levels and other health markers are monitored. The study aims to provide insights into how erythritol affects blood clotting and overall health, as previous studies have shown mixed results. This research is important because it may help develop better dietary recommendations to prevent obesity and related health problems in young people.

Gender

ALL

Eligibility 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.))
• • 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.))