Exploration of Potential Biomarkers of Polyphenol Intake From Artichoke By-product Supplements

Официальное название

Exploration of Potential Biomarkers of Polyphenol Intake From a Supplement Derived From Artichoke By-products Rich in Hydroxycinnamic Acids

Обзор

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.

Вмешательства

• Пищевая добавка Single intake of a supplement derived from artichoke by-products
  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.

Первичные конечные точки

• Change in the qualitative identification of HCAs and their metabolites of dehydrated artichoke by-product in urine between baseline and 48 h post-consumption [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline, 0-4 hours, 4-7 hours, 7-12 hours, 12-24 hours, and 24-48 hours]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Испания · 1 центр

• Universidad de Navarra — Pamplona

Идентификаторы

NCT: NCT07615673 · ARTI-UP ADME

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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