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

Örebro University, Sweden

Status: Enrolling

Conditions: Ileostomy - Stoma

Treatments: Dietary Supplement: Pea Protein, low bioavailability; Dietary Supplement: Pea Protein, high bioavailability; Dietary Supplement: Protein-free meal; Dietary Supplement: Oat Protein, low bioavailability; Dietary Supplement: Oat Protein, high bioavailability

Study type: Interventional

Funder types: Other

Identifiers

NCT06142084

Dnr 2023-04189-01

Details and patient eligibility

About

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.

Enrollment: 11 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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11 participants in 11 patient groups

Dietary Intervention Sequence 1 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x))

Experimental group

Description:

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

Treatment:

Dietary Supplement: Oat Protein, high bioavailability

Dietary Supplement: Oat Protein, low bioavailability

Dietary Supplement: Protein-free meal

Dietary Supplement: Pea Protein, high bioavailability

Dietary Supplement: Pea Protein, low bioavailability

Dietary Intervention Sequence 2 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x))

Experimental group

Description:

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

Treatment:

Dietary Supplement: Oat Protein, high bioavailability

Dietary Supplement: Oat Protein, low bioavailability

Dietary Supplement: Protein-free meal

Dietary Supplement: Pea Protein, high bioavailability

Dietary Supplement: Pea Protein, low bioavailability

Dietary Intervention Sequence 3 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x))

Experimental group

Description:

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

Treatment:

Dietary Supplement: Oat Protein, high bioavailability

Dietary Supplement: Oat Protein, low bioavailability

Dietary Supplement: Protein-free meal

Dietary Supplement: Pea Protein, high bioavailability

Dietary Supplement: Pea Protein, low bioavailability

Dietary Intervention Sequence 4 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x))

Experimental group

Description:

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

Treatment:

Dietary Supplement: Oat Protein, high bioavailability

Dietary Supplement: Oat Protein, low bioavailability

Dietary Supplement: Protein-free meal

Dietary Supplement: Pea Protein, high bioavailability

Dietary Supplement: Pea Protein, low bioavailability

Dietary Intervention Sequence 5 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x))

Experimental group

Description:

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

Treatment:

Dietary Supplement: Oat Protein, high bioavailability

Dietary Supplement: Oat Protein, low bioavailability

Dietary Supplement: Protein-free meal

Dietary Supplement: Pea Protein, high bioavailability

Dietary Supplement: Pea Protein, low bioavailability

Dietary Intervention Sequence 6 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x))

Experimental group

Description:

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

Treatment:

Dietary Supplement: Oat Protein, high bioavailability

Dietary Supplement: Oat Protein, low bioavailability

Dietary Supplement: Protein-free meal

Dietary Supplement: Pea Protein, high bioavailability

Dietary Supplement: Pea Protein, low bioavailability

Dietary Intervention Sequence 7 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x))

Experimental group

Description:

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

Treatment:

Dietary Supplement: Oat Protein, high bioavailability

Dietary Supplement: Oat Protein, low bioavailability

Dietary Supplement: Protein-free meal

Dietary Supplement: Pea Protein, high bioavailability

Dietary Supplement: Pea Protein, low bioavailability

Dietary Intervention Sequence 8 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x))

Experimental group

Description:

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

Treatment:

Dietary Supplement: Oat Protein, high bioavailability

Dietary Supplement: Oat Protein, low bioavailability

Dietary Supplement: Protein-free meal

Dietary Supplement: Pea Protein, high bioavailability

Dietary Supplement: Pea Protein, low bioavailability

Dietary Intervention Sequence 9 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x))

Experimental group

Description:

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

Treatment:

Dietary Supplement: Oat Protein, high bioavailability

Dietary Supplement: Oat Protein, low bioavailability

Dietary Supplement: Protein-free meal

Dietary Supplement: Pea Protein, high bioavailability

Dietary Supplement: Pea Protein, low bioavailability

Dietary Intervention Sequence 10 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x))

Experimental group

Description:

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

Treatment:

Dietary Supplement: Oat Protein, high bioavailability

Dietary Supplement: Oat Protein, low bioavailability

Dietary Supplement: Protein-free meal

Dietary Supplement: Pea Protein, high bioavailability

Dietary Supplement: Pea Protein, low bioavailability

Dietary Intervention Sequence 11 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x))

Experimental group

Description:

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

Treatment:

Dietary Supplement: Oat Protein, high bioavailability

Dietary Supplement: Oat Protein, low bioavailability

Dietary Supplement: Protein-free meal

Dietary Supplement: Pea Protein, high bioavailability

Dietary Supplement: Pea Protein, low bioavailability