PAN-Prodig: Digestibility of Different Plant-based Proteins in Humans With Ileostomy

• Sponsor: Örebro University, Sweden (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06142084
• Collaborator: (none)
• Enrollment: 11
• Location: 1
• Arms: 11
• Anticipated Duration (Months): 5
• Patients Per Site Per Month: 2.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Ileostomy - Stoma	Dietary Supplement: Oat Protein, low bioavailability; Dietary Supplement: Oat Protein, high bioavailability; Dietary Supplement: Pea Protein, low bioavailability; Dietary Supplement: Pea Protein, high bioavailability; Dietary Supplement: Protein-free meal	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 11 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: True Ileal Digestibility of Different Plant-based Proteins in a Human Ileostomy Model
• Anticipated Study Start Date: Dec 1, 2023
• Anticipated Primary Completion Date: May 1, 2024
• Anticipated Study Completion Date: May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dietary Intervention Sequence 1 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)) The participant will consume the below mentioned meals in a random order on five different study days (one on each visit): Protein meal: pea protein, low bioavailability Protein meal: pea protein, high bioavailability Protein meal: oat protein, low bioavailability Protein meal: oat protein, high bioavailability Protein-free meal	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).; Dietary Supplement: 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).; Dietary Supplement: 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).; Dietary Supplement: 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).; Dietary Supplement: Protein-free meal; Participants will consume a protein-free meal to correct analyses for endogenous protein losses.
Experimental: Dietary Intervention Sequence 2 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)) The participant will consume the below mentioned meals in a random order on five different study days (one on each visit): Protein meal: pea protein, low bioavailability Protein meal: pea protein, high bioavailability Protein meal: oat protein, low bioavailability Protein meal: oat protein, high bioavailability Protein-free meal	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).; Dietary Supplement: 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).; Dietary Supplement: 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).; Dietary Supplement: 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).; Dietary Supplement: Protein-free meal; Participants will consume a protein-free meal to correct analyses for endogenous protein losses.
Experimental: Dietary Intervention Sequence 3 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)) The participant will consume the below mentioned meals in a random order on five different study days (one on each visit): Protein meal: pea protein, low bioavailability Protein meal: pea protein, high bioavailability Protein meal: oat protein, low bioavailability Protein meal: oat protein, high bioavailability Protein-free meal	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).; Dietary Supplement: 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).; Dietary Supplement: 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).; Dietary Supplement: 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).; Dietary Supplement: Protein-free meal; Participants will consume a protein-free meal to correct analyses for endogenous protein losses.
Experimental: Dietary Intervention Sequence 4 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)) The participant will consume the below mentioned meals in a random order on five different study days (one on each visit): Protein meal: pea protein, low bioavailability Protein meal: pea protein, high bioavailability Protein meal: oat protein, low bioavailability Protein meal: oat protein, high bioavailability Protein-free meal	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).; Dietary Supplement: 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).; Dietary Supplement: 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).; Dietary Supplement: 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).; Dietary Supplement: Protein-free meal; Participants will consume a protein-free meal to correct analyses for endogenous protein losses.
Experimental: Dietary Intervention Sequence 5 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)) The participant will consume the below mentioned meals in a random order on five different study days (one on each visit): Protein meal: pea protein, low bioavailability Protein meal: pea protein, high bioavailability Protein meal: oat protein, low bioavailability Protein meal: oat protein, high bioavailability Protein-free meal	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).; Dietary Supplement: 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).; Dietary Supplement: 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).; Dietary Supplement: 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).; Dietary Supplement: Protein-free meal; Participants will consume a protein-free meal to correct analyses for endogenous protein losses.
Experimental: Dietary Intervention Sequence 6 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)) The participant will consume the below mentioned meals in a random order on five different study days (one on each visit): Protein meal: pea protein, low bioavailability Protein meal: pea protein, high bioavailability Protein meal: oat protein, low bioavailability Protein meal: oat protein, high bioavailability Protein-free meal	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).; Dietary Supplement: 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).; Dietary Supplement: 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).; Dietary Supplement: 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).; Dietary Supplement: Protein-free meal; Participants will consume a protein-free meal to correct analyses for endogenous protein losses.
Experimental: Dietary Intervention Sequence 7 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)) The participant will consume the below mentioned meals in a random order on five different study days (one on each visit): Protein meal: pea protein, low bioavailability Protein meal: pea protein, high bioavailability Protein meal: oat protein, low bioavailability Protein meal: oat protein, high bioavailability Protein-free meal	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).; Dietary Supplement: 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).; Dietary Supplement: 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).; Dietary Supplement: 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).; Dietary Supplement: Protein-free meal; Participants will consume a protein-free meal to correct analyses for endogenous protein losses.
Experimental: Dietary Intervention Sequence 8 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)) The participant will consume the below mentioned meals in a random order on five different study days (one on each visit): Protein meal: pea protein, low bioavailability Protein meal: pea protein, high bioavailability Protein meal: oat protein, low bioavailability Protein meal: oat protein, high bioavailability Protein-free meal	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).; Dietary Supplement: 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).; Dietary Supplement: 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).; Dietary Supplement: 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).; Dietary Supplement: Protein-free meal; Participants will consume a protein-free meal to correct analyses for endogenous protein losses.
Experimental: Dietary Intervention Sequence 9 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)) The participant will consume the below mentioned meals in a random order on five different study days (one on each visit): Protein meal: pea protein, low bioavailability Protein meal: pea protein, high bioavailability Protein meal: oat protein, low bioavailability Protein meal: oat protein, high bioavailability Protein-free meal	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).; Dietary Supplement: 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).; Dietary Supplement: 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).; Dietary Supplement: 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).; Dietary Supplement: Protein-free meal; Participants will consume a protein-free meal to correct analyses for endogenous protein losses.
Experimental: Dietary Intervention Sequence 10 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)) The participant will consume the below mentioned meals in a random order on five different study days (one on each visit): Protein meal: pea protein, low bioavailability Protein meal: pea protein, high bioavailability Protein meal: oat protein, low bioavailability Protein meal: oat protein, high bioavailability Protein-free meal	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).; Dietary Supplement: 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).; Dietary Supplement: 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).; Dietary Supplement: 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).; Dietary Supplement: Protein-free meal; Participants will consume a protein-free meal to correct analyses for endogenous protein losses.
Experimental: Dietary Intervention Sequence 11 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)) The participant will consume the below mentioned meals in a random order on five different study days (one on each visit): Protein meal: pea protein, low bioavailability Protein meal: pea protein, high bioavailability Protein meal: oat protein, low bioavailability Protein meal: oat protein, high bioavailability Protein-free meal	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).; Dietary Supplement: 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).; Dietary Supplement: 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).; Dietary Supplement: 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).; Dietary Supplement: Protein-free meal; Participants will consume a protein-free meal to correct analyses for endogenous protein losses.

Outcome Measures

Primary Outcome Measures

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

   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

Secondary Outcome Measures

1. Protein and metabolite profiles in ileostomy digesta [0-5 hours after consumption of test meal (on all 5 study days)]

   The secondary outcomes are defined as changes in protein and metabolite profiles in the digesta, determined by proteomics and metabolomic analyses.

2. Differences between in vivo and in vitro data [In vivo data: 0-5 hours after consumption of test meal (on all 5 study days)]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Örebro University	Örebro		Sweden	70182

Sponsors and Collaborators

• Örebro University, Sweden

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Örebro University, Sweden
• ClinicalTrials.gov Identifier: NCT06142084
• Other Study ID Numbers: Dnr 2023-04189-01
• First Posted: Nov 21, 2023
• Last Update Posted: Nov 21, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Örebro University, Sweden: Protein; Plant-based; Digestibility

Study Results

No Results Posted as of Nov 21, 2023