青少年の耐糖能に対する5週間にわたる毎日のエリスリトールとスクロースの摂取の影響 (EryAdo)
青少年の耐糖能に対する5週間にわたる毎日のエリスリトールとスクロースの摂取の影響：パイロット試験
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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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-
Canton of Basel-City
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Basel、Canton of Basel-City、スイス、4002
- St. Claraspital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.))
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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 |
|
実験的：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
他の名前：
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アクティブコンパレータ：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 |
|
アクティブコンパレータ：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 |
|
実験的：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
他の名前：
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実験的：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
他の名前：
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プラセボコンパレーター：EryClot Water
Participants receive 300mL water once during the visit |
300mL water administered once per visit |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
EryAdo: Insulin resistance
時間枠：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
時間枠：0 and 60 minutes
|
Measuring ex vivo platelet aggregation turbidimetrically using an optical aggregometer |
0 and 60 minutes
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
EryAdo: Glucose tolerance: Insulin
時間枠：Change from baseline to 5 weeks after polyol/sucrose intake
|
Insulin levels during OGTT |
Change from baseline to 5 weeks after polyol/sucrose intake
|
|
EryAdo: Glucose tolerance: Glucose
時間枠：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
時間枠：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
時間枠：Change from baseline to 5 weeks after polyol/sucrose intake
|
Glucagon levels during OGTT |
Change from baseline to 5 weeks after polyol/sucrose intake
|
|
EryAdo: Glucose tolerance: Fructosamin
時間枠：Change from baseline to 5 weeks after polyol/sucrose intake
|
Fructosamin levels |
Change from baseline to 5 weeks after polyol/sucrose intake
|
|
EryAdo: Glucose tolerance: HbA1C
時間枠：Change from baseline to 5 weeks after polyol/sucrose intake
|
HbA1C levels |
Change from baseline to 5 weeks after polyol/sucrose intake
|
|
EryAdo: Glucose tolerance: Continuous glucose monitoring average
時間枠：Change from baseline to 5 weeks after polyol/sucrose intake
|
Continuous glucose monitoring for average glucose levels |
Change from baseline to 5 weeks after polyol/sucrose intake
|
|
EryAdo: Glucose tolerance: Continuous glucose monitoring glucose variability
時間枠：Change from baseline to 5 weeks after polyol/sucrose intake
|
Continuous glucose monitoring for glucose variability |
Change from baseline to 5 weeks after polyol/sucrose intake
|
|
EryAdo: Glucose tolerance: Continuous glucose monitoring time within range
時間枠：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
|
|
EryAdo: Glucose absorption
時間枠：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
|
|
EryAdo: Metabolomics
時間枠：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
|
|
EryAdo: Gut microbiota composition
時間枠：Change from baseline to 5 weeks after polyol/sucrose intake
|
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
|
|
EryAdo: Gastrointestinal hormones secretion: GLP-1
時間枠：Change from baseline to 5 weeks after polyol/sucrose intake
|
Secretion of GLP-1 during OGTT |
Change from baseline to 5 weeks after polyol/sucrose intake
|
|
EryAdo: Gastrointestinal hormones secretion: PYY
時間枠：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
|
|
EryAdo: Gastrointestinal hormones secretion: Ghrelin
時間枠：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
|
|
EryAdo: Gastrointestinal hormones secretion: CCK
時間枠：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
|
|
EryAdo: Food intake
時間枠：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
|
|
EryAdo: Gastrointestinal tolerance
時間枠：Change from baseline to 3 and 5 weeks after polyol/sucrose intake
|
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
|
|
EryAdo: Body composition: fat mass
時間枠：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
|
|
EryAdo: Body composition: fat free mass
時間枠：Change from baseline to 5 weeks after polyol/sucrose intake
|
Body composition assessed by mean of bioimpedance analysis: fat free mass in kg |
Change from baseline to 5 weeks after polyol/sucrose intake
|
|
EryClot blood p-selectin concentrations
時間枠：Blood samples at timepoint t= -60, -1, 30, 60, 120, 180 minutes and 24, 48 hours
|
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
|
|
EryClot blood sVCAM1 concentrations
時間枠：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
|
|
EryClot blood PF4 concentrations
時間枠：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
|
|
EryClot blood D-Dimer concentrations
時間枠：Blood samples at timepoint t= -60, -1, 30, 60, 120, 180 minutes and 24, 48 hours
|
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
時間枠：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
|
|
EryClot blood Xylitol concentrations
時間枠：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
|
協力者と研究者
捜査官
- 主任研究者：Bettina K. Wölnerhanssen, PD. MD、St. Clara Research Ltd.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- EryAdo
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
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