Exploration of Potential Biomarkers of Polyphenol Intake From a Supplement Derived From Artichoke By-products Rich in Hydroxycinnamic Acids (ARTI-UP ADME) (ARTI-UP ADME)
2026年5月22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.
調査の概要
状態
募集
研究の種類
介入
入学 (推定)
16
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Iziar A Ludwig, PhD
- 電話番号：806652 +34 948425600
- メール：uinclint@unav.es
研究連絡先のバックアップ
- 名前：Idoia Ibero, PhD
- 電話番号：806699 +34 948 425 600
- メール：iibero@unav.es
研究場所
-
-
Navarre
-
Pamplona、Navarre、スペイン、31008
- 募集
- Universidad de Navarra
-
コンタクト：
- Idoia Ibero, PhD
- 電話番号：806699 +34 948 425 600
- メール：iibero@unav.es
-
コンタクト：
- Iziar A Ludwig, PhD
- 電話番号：806652 +34 948 425600
- メール：iludwig@unav.es
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：基礎科学
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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 48h 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 197.4mg 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: 24h pre intake, 0-4, 4-8, 8-12, 12-24, and 24-48h.
|
A single dose of 6 capsules of dehydrated artichoke by-product (contains 197.4mg
HCAs) consumed within 15 minutes accompanied by 250ml of water
|
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 |
|---|---|---|
|
Change in qualitative identification of HCAs and their metabolites of dehydrated artichoke by product in urine between baseline and 48h post consumption
時間枠：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 qualitative identification of HCAs and their metabolites of dehydrated artichokes by product in plasma between baseline and 48h post consumption
時間枠：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 48h 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 48h post consumption
時間枠：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 24h post consumption
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Iziar Amaia Ludwig Sanz-Orrio、University of Navarra
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年5月26日
一次修了 (推定)
2026年6月25日
研究の完了 (推定)
2026年6月25日
試験登録日
最初に提出
2026年5月22日
QC基準を満たした最初の提出物
2026年5月22日
最初の投稿 (実際)
2026年5月29日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月29日
QC基準を満たした最後の更新が送信されました
2026年5月22日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- ARTI-UP ADME
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?
未定
IPD プランの説明
Anonymized individual data on the bioavailability and metabolism of HCAs will only be shared if noteworthy inter-individual variability is detected.
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
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。