Health Trials

Digestibility of Different Plant-based Proteins in Humans With Ileostomy

ConditionIleostomy - Stoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorÖrebro University, Sweden

About this trial

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.

Eligibility criteria

Qualifiers

Age: 18 - 75 years

Body mass index: 18.5 - 30 kg/m2

(double-loop) Ileostomy with an intact small bowel

Signed informed consent

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Oat Protein, low bioavailability
  • Oat Protein, high bioavailability
  • Pea Protein, low bioavailability
  • Pea Protein, high bioavailability
  • Protein-free meal

Treatment groups

11 Participants
are divided into 11 treatment groups

11

Treatment groups

See each treatment group below.

Sponsors and collaborators

Örebro University, Sweden

Lead sponsor

Source ClinicalTrials.gov