Effects of erythritol versus sucrose on glucose tolerance in adolescents
Effect of Daily Erythritol Versus Sucrose Intake Over 5 Weeks on Glucose Tolerance in Adolescents: a Pilot Trial
This study is testing if drinking beverages sweetened with erythritol instead of sugar can help healthy teenagers manage their blood sugar and overall health better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 14 Years to 55 Years |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 1 site (Basel, Basel-Stadt) |
| Trial ID | NCT04966299 on ClinicalTrials.gov |
What this trial studies
This trial investigates the impact of daily erythritol intake compared to sucrose over five weeks on insulin resistance and glucose metabolism in healthy adolescents. The study aims to determine how erythritol affects body composition, gastrointestinal tolerance, and overall metabolism. Participants will consume beverages sweetened with either erythritol or sucrose, and various health metrics will be monitored throughout the study period. The research seeks to provide insights into the potential benefits of erythritol as a sugar substitute in preventing obesity and related metabolic disorders.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adolescents aged 14-18 years with a normal weight and regular sugar consumption.
Not a fit: Patients with severe acute or chronic diseases, those who are pregnant, or individuals with specific dietary restrictions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a healthier alternative to sugar for adolescents, potentially reducing the risk of obesity and insulin resistance.
How similar studies have performed: Other studies have shown promising results with erythritol, but this specific approach in adolescents is relatively novel.
Eligibility criteria
Show full inclusion / 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.)) 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.))
Where this trial is running
Basel, Basel-Stadt
- St. Claraspital — Basel, Basel-Stadt, Switzerland (Recruiting)
Study contacts
- Principal investigator: Bettina K. Wölnerhanssen, PD. MD — St. Clara Research Ltd.
- Study coordinator: Bettina K. Wölnerhanssen, PD. MD
- Email: bettina.woelnerhanssen@claraspital.ch
- Phone: + 41 61 685 86 32
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.