청소년의 포도당 내성에 대한 5주 이상의 일일 에리스리톨 대 자당 섭취의 효과 (EryAdo)
청소년의 포도당 내성에 대한 5주 이상의 일일 에리스리톨 대 자당 섭취 효과: 파일럿 시험
This trial is divided into different parts: Part A the EryAdo trial and Part B the EryClot trial.
Part A EryAdo Trial:
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.
Part B EryClot Trial:
In recently published studies, a prothrombotic effect of erythritol and xylitol was described.
Therefore, within a pilot study the investigators examined whether erythritol is detectable in the blood after administration of erythritol and conventional sweeteners (glucose and fructose). Also the effect on blood clotting was investigated.
These preliminary tests served to clarify the data situation so that further studies can be based on them.
The preliminary results of the pilot study indicated that there appears to be no measurable effect of erythritol on thrombocyte aggregation. This implicated 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 in more detail (thrombocyte aggregation, and markers of platelet activation, endothelial activation and coagulation) in more subjects.
Due to a study published in 2024 describing similar prothrombotic effects for xylitol, this substance needs to be investigated as well. Thus, the participants will receive erythritol, xylitol, or water in a randomized order.
In addition to the EryClot ex vivo experiments, we will conduct in vitro experiments incubating platelet-rich plasma from healthy donors with increasing concentrations erythritol or xylitol followed by measurement of platelet aggregation by aggreegometry assay.
연구 개요
상태
상세 설명
Part A EryAdo Trial:
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.
Part B EryClot Trial:
The aim of this study is to investigate whether erythritol is detectable in the blood after administration of glucose and fructose, whether there is an effect of erythritol or xylitol on blood clotting and to investigate the platelet responsiveness in vitro in human plasma after addition of erythritol and xylitol.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Canton of Basel-City
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Basel, Canton of Basel-City, 스위스, 4002
- St. Claraspital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Part A EryAdo Trial:
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.)
Part B EryClot Trial:
Inclusion criteria:
- Healthy participants 18-55 years upon inclusion
- Normal weight (BMI between 19.0-24.9 kg/m2; for in vitro: 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. In female participants a urine pregnancy test is carried out upon screening
- 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.))
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: EryAdo: Sucrose
Participants receive 25g sucrose per day during 5 weeks |
Sucrose-sweetened beverages twice a day (25g sucrose/day) with main meals during 5 weeks |
|
실험적: EryAdo: Erythritol
Participants receive 36g erythritol per day during 5 weeks |
EryAdo: Erythritol-sweetened beverages twice a day (36g erythritol/day) with main meals during 5 weeks EryClot: Erythritol 50g dissolved in 300mL water administered once per visit
다른 이름들:
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활성 비교기: EryClot Glucose
Participants receive 75g glucose dissolved in 300mL water once during the visit (only in the pilot study) |
Glucose 75g dissolved in 300mL water administered once per visit |
|
활성 비교기: EryClot Fructose
Participants receive 25g fructose dissolved in 300mL water once during the visit (only in the pilot study) |
Fructose 25g dissolved in 300mL water administered once per visit |
|
실험적: EryClot Erythritol
Participants receive 50g erythritol dissolved in 300mL water once during the visit |
EryAdo: Erythritol-sweetened beverages twice a day (36g erythritol/day) with main meals during 5 weeks EryClot: Erythritol 50g dissolved in 300mL water administered once per visit
다른 이름들:
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실험적: EryClot Xylitol
Participants receive 33.5g xylitol dissolved in 300mL water once during the visit |
Xylitol 33.5g dissolved in 300mL water administered once per visit
다른 이름들:
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위약 비교기: EryClot Water
Participants receive 300mL water once during the visit |
300mL water administered once per visit |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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EryAdo: Insulin resistance
기간: Change from baseline to 5 weeks after polyol/sucrose intake
|
Insulin resistance as measured by the HOMA Index. |
Change from baseline to 5 weeks after polyol/sucrose intake
|
|
EryClot: Platelet Aggregation After Sweetener Ingestion
기간: 0 and 60 minutes
|
Measuring ex vivo platelet aggregation turbidimetrically using an optical aggregometer |
0 and 60 minutes
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
EryAdo: Glucose tolerance: Insulin
기간: Change from baseline to 5 weeks after polyol/sucrose intake
|
Insulin levels during OGTT |
Change from baseline to 5 weeks after polyol/sucrose intake
|
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EryAdo: Glucose tolerance: Glucose
기간: Change from baseline to 5 weeks after polyol/sucrose intake
|
Glucose levels during OGTT |
Change from baseline to 5 weeks after polyol/sucrose intake
|
|
EryAdo: Glucose tolerance: C-Peptide
기간: Change from baseline to 5 weeks after polyol/sucrose intake
|
C-peptide levels during OGTT |
Change from baseline to 5 weeks after polyol/sucrose intake
|
|
EryAdo: Glucose tolerance: Glucagon
기간: Change from baseline to 5 weeks after polyol/sucrose intake
|
Glucagon levels during OGTT |
Change from baseline to 5 weeks after polyol/sucrose intake
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EryAdo: Glucose tolerance: Fructosamin
기간: Change from baseline to 5 weeks after polyol/sucrose intake
|
Fructosamin levels |
Change from baseline to 5 weeks after polyol/sucrose intake
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EryAdo: Glucose tolerance: HbA1C
기간: Change from baseline to 5 weeks after polyol/sucrose intake
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HbA1C levels |
Change from baseline to 5 weeks after polyol/sucrose intake
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EryAdo: Glucose tolerance: Continuous glucose monitoring average
기간: Change from baseline to 5 weeks after polyol/sucrose intake
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Continuous glucose monitoring for average glucose levels |
Change from baseline to 5 weeks after polyol/sucrose intake
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EryAdo: Glucose tolerance: Continuous glucose monitoring glucose variability
기간: Change from baseline to 5 weeks after polyol/sucrose intake
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Continuous glucose monitoring for glucose variability |
Change from baseline to 5 weeks after polyol/sucrose intake
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EryAdo: Glucose tolerance: Continuous glucose monitoring time within range
기간: Change from baseline to 5 weeks after polyol/sucrose intake
|
Continuous glucose monitoring for time within range |
Change from baseline to 5 weeks after polyol/sucrose intake
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EryAdo: Glucose absorption
기간: Change from baseline to 5 weeks after polyol/sucrose intake
|
Glucose absorption measured by 3-OMG concetrations during OGTT |
Change from baseline to 5 weeks after polyol/sucrose intake
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EryAdo: Metabolomics
기간: Change from baseline to 5 weeks after polyol/sucrose intake
|
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
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EryAdo: Gut microbiota composition
기간: Change from baseline to 5 weeks after polyol/sucrose intake
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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
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EryAdo: Gastrointestinal hormones secretion: GLP-1
기간: Change from baseline to 5 weeks after polyol/sucrose intake
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Secretion of GLP-1 during OGTT |
Change from baseline to 5 weeks after polyol/sucrose intake
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EryAdo: Gastrointestinal hormones secretion: PYY
기간: Change from baseline to 5 weeks after polyol/sucrose intake
|
Secretion of PYY during OGTT |
Change from baseline to 5 weeks after polyol/sucrose intake
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EryAdo: Gastrointestinal hormones secretion: Ghrelin
기간: Change from baseline to 5 weeks after polyol/sucrose intake
|
Secretion of Ghrelin during OGTT |
Change from baseline to 5 weeks after polyol/sucrose intake
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EryAdo: Gastrointestinal hormones secretion: CCK
기간: Change from baseline to 5 weeks after polyol/sucrose intake
|
Secretion of CCK during OGTT |
Change from baseline to 5 weeks after polyol/sucrose intake
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EryAdo: Food intake
기간: Change from baseline to 5 weeks after polyol/sucrose intake
|
Food intake assessed with self-reported food records |
Change from baseline to 5 weeks after polyol/sucrose intake
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EryAdo: Gastrointestinal tolerance
기간: Change from baseline to 3 and 5 weeks after polyol/sucrose intake
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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
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EryAdo: Body composition: fat mass
기간: Change from baseline to 5 weeks after polyol/sucrose intake
|
Body composition assessed by mean of bioimpedance analysis: fat mass in kg |
Change from baseline to 5 weeks after polyol/sucrose intake
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EryAdo: Body composition: fat free mass
기간: Change from baseline to 5 weeks after polyol/sucrose intake
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Body composition assessed by mean of bioimpedance analysis: fat free mass in kg |
Change from baseline to 5 weeks after polyol/sucrose intake
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EryClot blood p-selectin concentrations
기간: Blood samples at timepoint t= -60, -1, 30, 60, 120, 180 minutes and 24, 48 hours
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Blood p-Selectin concentrations after consumption of test solution |
Blood samples at timepoint t= -60, -1, 30, 60, 120, 180 minutes and 24, 48 hours
|
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EryClot blood sVCAM1 concentrations
기간: Blood samples at timepoint t= -60, -1, 30, 60, 120, 180 minutes and 24, 48 hours
|
Blood sVCAM1 concentrations after consumption of test solution |
Blood samples at timepoint t= -60, -1, 30, 60, 120, 180 minutes and 24, 48 hours
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EryClot blood PF4 concentrations
기간: Blood samples at timepoint t= -60, -1, 30, 60, 120, 180 minutes and 24, 48 hours
|
Blood PF4 concentrations after consumption of test solution |
Blood samples at timepoint t= -60, -1, 30, 60, 120, 180 minutes and 24, 48 hours
|
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EryClot blood D-Dimer concentrations
기간: Blood samples at timepoint t= -60, -1, 30, 60, 120, 180 minutes and 24, 48 hours
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Blood D-Dimer concentrations after consumption of test solution |
Blood samples at timepoint t= -60, -1, 30, 60, 120, 180 minutes and 24, 48 hours
|
|
EryClot blood Erythritol concentrations
기간: Blood samples at timepoint t= -60, -1, 30, 60, 120, 180 minutes and 24, 48 hours
|
Blood erythritol concentrations after consumption of test solution |
Blood samples at timepoint t= -60, -1, 30, 60, 120, 180 minutes and 24, 48 hours
|
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EryClot blood Xylitol concentrations
기간: Blood samples at timepoint t= -60, -1, 30, 60, 120, 180 minutes and 24, 48 hours
|
Blood xylitol concentrations after consumption of test solution |
Blood samples at timepoint t= -60, -1, 30, 60, 120, 180 minutes and 24, 48 hours
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Bettina K. Wölnerhanssen, PD. MD, St. Clara Research Ltd.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- EryAdo
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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