Exploration of Potential Biomarkers of Polyphenol Intake From Artichoke By-product Supplements (ARTI-UP ADME)
2026年6月1日 更新者：Iziar Amaia Ludwig Sanz Orrio
Exploration of Potential Biomarkers of Polyphenol Intake From a Supplement Derived From Artichoke By-products Rich in Hydroxycinnamic Acids
The bioavailability study analyzes the absorption, distribution, metabolism, and excretion (ADME) processes of the polyphenols under study (HCAs). To achieve the planned objectives, blood and urine samples will be collected before and at different time intervals following the intake of the study supplement, which will consist of capsules made from dehydrated artichoke by-products rich in HCAs.
To determine the bioavailability of the active compounds, volunteers will be asked to follow a diet low in polyphenols/plant-based foods for 48 hours prior to the supplement intake and up to 48 hours after product consumption. Blood and urine samples will be collected before intake and during the following 48 hours. Subsequently, the samples will be analyzed using high-performance liquid chromatography coupled with mass spectrometry (HPLC-MS) to identify and quantify the bioactive compounds of interest and their metabolites. The results of the ADME trial will allow for the identification of plasma and urinary metabolites, the characterization of intake markers, and the determination of inter-individual differences in metabolic profiles.
研究概览
地位
招聘中
研究类型
介入性
注册 (估计的)
16
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Iziar A Ludwig, PhD
- 电话号码：806652 +34 948425600
- 邮箱：uinclint@unav.es
研究联系人备份
- 姓名：Idoia Ibero, PhD
- 电话号码：806699 +34 948 425 600
- 邮箱：iibero@unav.es
学习地点
-
-
Navarre
-
Pamplona、Navarre、西班牙、31008
- 招聘中
- Universidad de Navarra
-
接触：
- Idoia Ibero, PhD
- 电话号码：806699 +34 948 425 600
- 邮箱：iibero@unav.es
-
接触：
- Iziar A Ludwig, PhD
- 电话号码：806652 +34 948 425600
- 邮箱：iludwig@unav.es
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
描述
Inclusion Criteria:
- Men and women between 18 and 75 years of age.
- Normal-weight volunteers (BMI of 18.5-24.9 kg/m²).
- Subjects must be able to understand and willing to sign the informed consent form, and must comply with all study procedures and requirements.
Exclusion Criteria:
- Presence of chronic gastrointestinal pathology.
- Lactating or pregnant women, or those planning to become pregnant.
- Individuals who have taken antibiotics within the 3 months prior to the study.
- Individuals currently taking supplements (plant-derived, fiber, or probiotics) unless they are willing to discontinue use during the 4-day study intervention and ensure a minimum washout period of 14 days prior to baseline measurements.
- Individuals with an alcohol intake > 80 g/day.
- Presence of allergy or intolerance to artichoke.
- Individuals undergoing treatment with anticoagulants, immunosuppressants, or cytotoxic agents.
- Presence of renal or hepatic failure.
- Presence of immunodeficiency or being HIV positive.
- Subjects with any type of cancer, those undergoing cancer treatment, or those for whom at least 5 years have not passed since remission.
- Presence of weight loss greater than 5% in the 6 months prior to the trial.
- Lack of time or geographical availability to attend the study visits.
- Failure to sign the informed consent form.
- Difficulty in undergoing blood extraction/collection.
- Having donated blood within 14 days prior to the baseline visit.
- Individuals who demonstrate difficulty swallowing capsules, tablets, pills, or similar.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Dietary Intervention: Single intake of a supplement derived from artichoke by-products
Subjects will be asked to follow a low-(poly)phenol diet during the preceding two days and during the 48 h of the dietary intervention.
On the day of the study, each volunteer will ingest the content of 6 capsules containing the amount of by-product artichoke powder able to deliver 197.4 mg of HCAs after fasting overnight.
Blood samples at baseline (0 h) and different post-intake times (1, 2, 4, 7, 24, and 48 h) will be collected.
Urine samples will be collected in the following time intervals: 24 h pre-intake, 0-4, 4-8, 8-12, 12-24, and 24-48 h.
|
A single dose of 6 capsules of dehydrated artichoke by-product (containing 197.4 mg HCAs) consumed within 15 minutes accompanied by 250 ml of water.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in the qualitative identification of HCAs and their metabolites of dehydrated artichoke by-product in urine between baseline and 48 h post-consumption
大体时间：Baseline, 0-4 hours, 4-7 hours, 7-12 hours, 12-24 hours, and 24-48 hours
|
Change in HCAs and their metabolites in urine between baseline and 48h post consumption will be measured by identifying qualitatively metabolites from dehydrated artichokes by-products at different time points using chromatography coupled with mass spectrometry analytical techniques (UPLC-MS).
|
Baseline, 0-4 hours, 4-7 hours, 7-12 hours, 12-24 hours, and 24-48 hours
|
|
Change in the qualitative identification of HCAs and their metabolites of dehydrated artichokes by-product in plasma between baseline and 48 h post consumption
大体时间：Baseline, 1 hours, 2 hour, 4 hours, 7 hours, 24 hours, and 48 hours
|
Change in HCAs and their metabolites in plasma between baseline and 48 h post consumption will be measured by identifying qualitatively metabolites from dehydrated artichoke by-product at different time points using chromatography coupled with mass spectrometry analytical techniques (UPLC-MS).
|
Baseline, 1 hours, 2 hour, 4 hours, 7 hours, 24 hours, and 48 hours
|
|
Change in the plasmatic concentration of HCAs (nanomol/L) and their metabolites of dehydrated artichoke by-prodcuts between baseline and 48 h post consumption
大体时间：Baseline, 1 hours, 2 hour, 4 hours, 7 hours, 24 hours, and 48 hours
|
Bioavailability and metabolism from artichoke by-product polyphenols will be studied by evaluating changes in concentration of HCA and their metabolites (nanomol/L) in plasma samples at different time points using chromatography coupled with mass spectrometry analytical techniques (UPLC-MS).
|
Baseline, 1 hours, 2 hour, 4 hours, 7 hours, 24 hours, and 48 hours
|
|
Change in the concentration of artichoke by-product HCAs in urine (nanomol/L) and their metabolites between baseline and 24 h post consumption
大体时间：Baseline, 0-4 hours, 4-7 hours, 7-12 hours, 12-24 hours, and 24-48 hours
|
Metabolism and excretion from artichoke by-product polyphenols will be studied by evaluating changes in HCAs and their metabolite concentration (nanomol/L) in urine samples at different time points using chromatography coupled with mass spectrometry analytical techniques (UPLC-MS).
|
Baseline, 0-4 hours, 4-7 hours, 7-12 hours, 12-24 hours, and 24-48 hours
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Iziar A Ludwig Sanz-Orrio、University of Navarra
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年5月26日
初级完成 (估计的)
2026年6月25日
研究完成 (估计的)
2026年6月25日
研究注册日期
首次提交
2026年5月22日
首先提交符合 QC 标准的
2026年5月22日
首次发布 (实际的)
2026年5月29日
研究记录更新
最后更新发布 (实际的)
2026年6月3日
上次提交的符合 QC 标准的更新
2026年6月1日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
其他研究编号
- ARTI-UP ADME
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
Anonymized individual data on the bioavailability and metabolism of HCAs will only be shared if noteworthy inter-individual variability is detected.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.