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Digestibility of Different Plant-based Proteins in Humans With Ileostomy

Study acronym: PAN-Prodig
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary completion date: Apr 2026 to Sep 2027
    • Start date: Sep 2025 to Sep 2026
    • Study completion date: Sep 2026 to Dec 2028
    v4
  2. Notable Primary completion date: Dec 2024 to Apr 2026
    • Start date: Apr 2024 to Sep 2025
    • Study completion date: Dec 2024 to Sep 2026
    v3
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: May 2024 to Dec 2024
    • Start date: Dec 2023 to Apr 2024
    • Site details revised
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06142084
Lead Sponsor Örebro University, Sweden
Conditions
(from sponsor)
Ileostomy - Stoma
Enrollment 11 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov