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Набор по приглашению NCT06921811

Bioavailability From Chickpea Meals in Ileostomists?

Без фазы С лечением Nutrition Absorption Polyphenolic Compounds and Metabolism Polyphenols Absorption Profile

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Intact chickpeas, Broken chickpeas.
Кому может быть актуально
Состояния в реестре: Nutrition, Absorption, Polyphenolic Compounds and Metabolism, Polyphenols Absorption Profile. Базовые параметры: 18 лет — 60 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Великобритания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Bioavailability of Macronutrients and Bioactive Compounds From Chickpea Meals: an Ileostomy Study.

Обзор

The matrix of a food can significantly affect how well humans can absorb and use nutrients. Plants like fruits, vegetables, nuts, grains, and legumes have cell walls that form a network around their cells. These cell walls are a barrier for the digestive system to break down completely, which can make it harder to digest the food and get energy from it. This study will explore how the integrity of plant cell walls affects how well humans can absorb macronutrients (protein, fat and carbohydrates) and beneficial compounds e.g. phytochemicals. The study will compare two chickpea meals that have similar nutrients and energy content but differ in the amount of intact plant cell walls e.g. chickpea salad meal (INTACT diet) and chickpea burger meal (BROKEN diet).

Подробное описание

The energy content of food can be in principle calculated by multiplying the content of each energy-yielding substrate by the corresponding heat of combustion. However, only part of this energy yielding substrates is converted to energy because of their incomplete digestion and absorption in the gastrointestinal tract. The structural composition of foods, known as the food matrix, significantly affects nutrient bioavailability. One such structural feature is the integrity of plant tissues characterised by the interconnected, continuous network of cell walls which surround and protect plant cells. When cellular integrity is retained, macronutrients are naturally "encapsulated" within cell walls which effectively reduces the rate and the extent of their digestibility by 6-7% compared to a diet poor in plant-based foods. This study aims to investigate the effect of plant tissue integrity on the total energy excretion of a diet, bioavailability of macronutrients and bioactive compounds, and on plasma levels of glucose, essential amino acids and triglycerides. The investigators will do this by comparing two diets which have (approximately) the same composition in macronutrients and energy but different levels of plant tissues integrity, namely a diet rich in intact plant tissues (INTACT diet), and a diet poor in such intact plant tissues (BROKEN diet). The investigators will use an ileostomy model to be able to determine the difference in energy excretion at the level of the terminal ileum.

Вмешательства

  • Другое Intact chickpeas
    Salad meal containing intact chickpeas
  • Другое Broken chickpeas
    Burger meal containing chickpea flour

Первичные конечные точки

  • Ileal fluid energy content [Срок оценки: Change over 8 hours comparison between treatments]
Вторичные конечные точки (12)
  • Ileal fluid macronutrient content [Срок оценки: Change over 8 hours comparison between treatments]
  • Ileal fluid alkylresorcinol content [Срок оценки: Change over 8 hours comparison between treatments]
  • Ileal fluid carotenoid content [Срок оценки: Change over 8 hours comparison between treatments]
  • Circulating glucose concentration [Срок оценки: Change over 8 hours comparison between treatments]
  • Urinary phenolic content [Срок оценки: Change over 8 hours comparison between treatments]
  • Circulating insulin, levels [Срок оценки: Change over 8 hours comparison between treatments]
  • Circulating essential amino acid levels [Срок оценки: Change over 8 hours comparison between treatments]
  • Circulating triglyceride levels [Срок оценки: Change over 8 hours comparison between treatments]
  • Circulating levels of GLP-1 [Срок оценки: Change over 8 hours comparison between treatments]
  • Circulating levels of GIP [Срок оценки: Change over 8 hours comparison between treatments]
  • Circulating levels of ghrelin [Срок оценки: Change over 8 hours comparison between treatments]
  • Circulating levels of CKK [Срок оценки: Change over 8 hours comparison between treatments]

Критерии участия

Критерии включения

  • Previously had an ileostomy
  • ≥1.5-years post-operative
  • Aged 18-60 years
  • Males and females (not currently pregnant/lactating)
  • Non-smokers
  • Not allergic to nuts and celery

Критерии исключения

  • Never had an ileostomy
  • <1.5-year post-operative
  • Not aged 18-60 years
  • Pregnant/lactating female
  • Smokers
  • Allergic to nuts and celery

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Простое слепое
Основная цель
Другое

Центры проведения

Великобритания · 1 центр
  • Human Intervention Studies Unit, Ulster University — Coleraine

Идентификаторы

NCT: NCT06921811 · REC/24/0083

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗