Effect of Daily Erythritol Versus Sucrose Intake Over 5 Weeks on Glucose Tolerance in Adolescents: a Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Insulin resistance
研究概览
简要总结
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).
详细描述
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.
EryClot:
The aim of this study is to investigate the erythritol level in blood after administration of erythritol and a possible effect on blood clotting function. Additionally, a possible effect of xylitol on blood clotting function will be investigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
- •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
- 另有 1 项未显示
结局指标
主要结局
Insulin resistance
时间窗: Change from baseline to 5 weeks after polyol/sucrose intake
Insulin resistance as measured by the HOMA Index.
EryClot-Pilot Thrombocyte aggregation
时间窗: Blood samples at timepoint t= 0, 30, 60, 120, 180 minutes
Thrombocyte aggregation after consumption of test solution measured with a blood sample
EryClot Thrombocyte aggregation
时间窗: Blood samples at timepoint t= -60, -1, 30, 60, 120, 180 minutes
Thrombocyte aggregation after consumption of test solution measured with a blood sample
EryClot in vitro: Platelet responsiveness in human platelet rich plasma
时间窗: One single fasting blood sample at timepoint t = -10 minutes
Aggregometry assay after addition of erythritol or xylitol in human platelet rich plasma
次要结局
- Body composition: fat free mass(Change from baseline to 5 weeks after polyol/sucrose intake)
- EryClot blood sVCAM1 concentrations(Blood samples at timepoint t= -60, -1, 30, 60, 120, 180 minutes and 24, 48 hours)
- Glucose tolerance: C-Peptide(Change from baseline to 5 weeks after polyol/sucrose intake)
- Body composition: fat mass(Change from baseline to 5 weeks after polyol/sucrose intake)
- Glucose tolerance: Continuous glucose monitoring glucose variability(Change from baseline to 5 weeks after polyol/sucrose intake)
- Glucose tolerance: Continuous glucose monitoring time within range(Change from baseline to 5 weeks after polyol/sucrose intake)
- Gut microbiota composition(Change from baseline to 5 weeks after polyol/sucrose intake)
- Gastrointestinal hormones secretion: PYY(Change from baseline to 5 weeks after polyol/sucrose intake)
- 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: Fructosamin(Change from baseline to 5 weeks after polyol/sucrose intake)
- Glucose tolerance: Continuous glucose monitoring average(Change from baseline to 5 weeks after polyol/sucrose intake)
- Gastrointestinal hormones secretion: GLP-1(Change from baseline to 5 weeks after polyol/sucrose intake)
- EryClot blood p-selectin concentrations(Blood samples at timepoint t= -60, -1, 30, 60, 120, 180 minutes and 24, 48 hours)
- Glucose tolerance: Glucagon(Change from baseline to 5 weeks after polyol/sucrose intake)
- Glucose tolerance: HbA1C(Change from baseline to 5 weeks after polyol/sucrose intake)
- Glucose absorption(Change from baseline to 5 weeks after polyol/sucrose intake)
- Metabolomics(Change from baseline to 5 weeks after polyol/sucrose intake)
- Gastrointestinal hormones secretion: Ghrelin(Change from baseline to 5 weeks after polyol/sucrose intake)
- Gastrointestinal hormones secretion: CCK(Change from baseline to 5 weeks after polyol/sucrose intake)
- Food intake(Change from baseline to 5 weeks after polyol/sucrose intake)
- Gastrointestinal tolerance(Change from baseline to 3 and 5 weeks after polyol/sucrose intake)
- EryClot-Pilot Blood Erythritol concentrations(Blood samples at timepoint t= 0, 30, 60, 120, 180 minutes and 24, 48 hours)
- EryClot blood Xylitol concentrations(Blood samples at timepoint t= -60, -1, 30, 60, 120, 180 minutes and 24, 48 hours)
- EryClot-Pilot Blood p-Selectin concentrations(Blood samples at timepoint t= 0, 30, 60, 120, 180 minutes and 24, 48 hours)
- EryClot blood Erythritol concentrations(Blood samples at timepoint t= -60, -1, 30, 60, 120, 180 minutes and 24, 48 hours)
- EryClot blood PF4 concentrations(Blood samples at timepoint t= -60, -1, 30, 60, 120, 180 minutes and 24, 48 hours)
- EryClot blood D-Dimers concentrations(Blood samples at timepoint t= -60, -1, 30, 60, 120, 180 minutes and 24, 48 hours)