Digestibility of Different Plant-based Proteins in Humans With Ileostomy

Ileostomy - Stoma Clinical Trial

— PAN-Prodig  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06142084
• Other study ID #: Dnr 2023-04189-01
• Status: Recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Örebro University, Sweden
• Contact: Robert Brummer, PhD
• Phone: 004619303731
• Email: robert.brummer[@]oru.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 11
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age: 18 - 75 years

• Body mass index: 18.5 - 30 kg/m2

• (double-loop) Ileostomy with an intact small bowel

• Signed informed consent

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Ileostomy - Stoma

Intervention

Dietary Supplement:
• 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).
• 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).
• 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).
• 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).
• Protein-free meal
Participants will consume a protein-free meal to correct analyses for endogenous protein losses.

Locations

Country	Name	City	State
Sweden	Örebro University	Örebro

Sponsors (1)

Lead Sponsor	Collaborator
Örebro University, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	True ileal digestibility of different plant-based proteins	The primary outcome is defined as the differences in the true ileal digestibility, determined by measuring the amount of nitrogen in the meal and the amount of unabsorbed nitrogen in the ileal fluid after consuming four different plant-based protein meals	0-5 hours after consumption of test meal (on all 5 study days)
Secondary	Protein and metabolite profiles in ileostomy digesta	The secondary outcomes are defined as changes in protein and metabolite profiles in the digesta, determined by proteomics and metabolomic analyses.	0-5 hours after consumption of test meal (on all 5 study days)
Secondary	Differences between in vivo and in vitro data	Results from the human ileostomy model will be compared with results from in vitro digestion according to the Infogest 2.0 protocol for each of the tested plant-based proteins	In vivo data: 0-5 hours after consumption of test meal (on all 5 study days)