Insulin Resistance Clinical Trial
— EryAdoOfficial title:
Effect of Daily Erythritol Versus Sucrose Intake Over 5 Weeks on Glucose Tolerance in Adolescents: a Pilot Trial
NCT number | NCT04966299 |
Other study ID # | EryAdo |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | August 18, 2021 |
Est. completion date | July 2024 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | St. Claraspital | Basel | Basel-Stadt |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Basel, Switzerland |
Switzerland,
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 |
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