Digestibility of Different Plant-based Proteins in Humans With Ileostomy

Официальное название

True Ileal Digestibility of Different Plant-based Proteins in a Human Ileostomy Model

Обзор

The goal of this interventional study is to learn about the digestibility of different plant-based proteins in adults (age 18-75) with an ileostomy. The main questions the study aims to answer are: 1. How does the digestibility of proteins in the small intestine differ between different plant-based proteins? 2. Which proteins and amino acids are not digested or absorbed in the small intestine and are available for further metabolic processes in the large intestine? 3. How do metabolites in the collected content of the ileostomy bag differ after consuming different plant-based proteins? 4. Can the in vivo results be compared to results from existing in vitro models? Participants will consume five different protein meals (oat protein - high bioavailable, oat protein - low bioavailable, pea protein - high bioavailable, pea protein low bioavailable, protein-free meal) on five different study days in a random order. Five hours after consuming the test meals ileostomy bags will be collected and the content will be analysed to answer the above mentioned research questions.

Вмешательства

• Пищевая добавка Oat Protein, low bioavailability
  Participants will consume a protein meal consisting of cooked whole oat kernels (amount based on body weight, 0.3g of protein/kg bodyweight).
• Пищевая добавка Oat Protein, high bioavailability
  Participants will consume a protein meal consisting of heated oat protein concentrate (amount based on body weight, 0.3g of protein/kg bodyweight).
• Пищевая добавка Pea Protein, low bioavailability
  Participants will consume a protein meal consisting of cooked whole yellow peas (amount based on body weight, 0.3g of protein/kg bodyweight).
• Пищевая добавка Pea Protein, high bioavailability
  Participants will consume a protein meal consisting of heated pea protein isolate (amount based on body weight, 0.3g of protein/kg bodyweight).
• Пищевая добавка Protein-free meal
  Participants will consume a protein-free meal to correct analyses for endogenous protein losses.

Первичные конечные точки

• True ileal digestibility of different plant-based proteins [Срок оценки: 0-5 hours after consumption of test meal (on all 5 study days)]

Вторичные конечные точки (2)

• Protein and metabolite profiles in ileostomy digesta [Срок оценки: 0-5 hours after consumption of test meal (on all 5 study days)]
• Differences between in vivo and in vitro data [Срок оценки: In vivo data: 0-5 hours after consumption of test meal (on all 5 study days)]

Критерии участия

Критерии включения

• Age: 18 - 75 years
• Body mass index: 18.5 - 30 kg/m2
• (double-loop) Ileostomy with an intact small bowel
• Signed informed consent

Критерии исключения

• Pregnancy or breastfeeding
• Ileostomy < 3 months before the study
• Any clinically significant present or past disease/condition other than colon cancer which in the investigator's opinion could interfere with the results of the trial
• Any clinically significant present or past medication which in the investigator's opinion could interfere with the results of the trial

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Тройное слепое

Основная цель

Фундаментальное исследование

Центры проведения

Швеция · 1 центр

• Örebro University — Örebro

Идентификаторы

NCT: NCT06142084 · Dnr 2023-04189-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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