Understanding how different plant-based proteins are digested in people with ileostomy
True Ileal Digestibility of Different Plant-based Proteins in a Human Ileostomy Model
This study is testing how well different plant-based proteins are digested in adults with an ileostomy to help improve their diet.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 11 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Örebro University, Sweden Academic / other |
| Locations | 1 site (Örebro) |
| Trial ID | NCT06142084 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to investigate the digestibility of various plant-based proteins in adults aged 18 to 75 who have an ileostomy. Participants will consume five different protein meals on separate days, including high and low bioavailable oat and pea proteins, as well as a protein-free meal. The study will analyze how well these proteins are digested in the small intestine and what metabolites are produced, with the goal of comparing in vivo results to existing in vitro models. The findings could provide insights into optimizing dietary protein sources for individuals with ileostomies.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 75 with a double-loop ileostomy and a body mass index between 18.5 and 30 kg/m2.
Not a fit: Patients who have had an ileostomy for less than three months or those with significant health conditions that could affect the study results may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help improve dietary recommendations for patients with ileostomies, enhancing their nutritional intake and overall health.
How similar studies have performed: While studies on protein digestibility exist, this specific investigation into plant-based proteins in ileostomy patients is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Örebro
- Örebro University — Örebro, Sweden (Recruiting)
Study contacts
- Study coordinator: Robert Brummer, PhD
- Email: robert.brummer@oru.se
- Phone: 004619303731
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.