Protein digestibility of bread made from enzyme treated flour in adults with an ileostomy

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2020
INTERVENTION: The study is designed as a completely randomised, double‐blinded, controlled cross‐over intervention. A total of 4 proctocolectomised adults with conventional and well‐functioning permanent ileostomies will be recruited. Eligibility will be confirmed by a screening questionnaire, followed by an in‐home screen involving assessment of vital signs and self‐reported medical history. The study will be conducted over 6 consecutive days within the participant’s home. This will comprise a 2‐day acclimation period in which study participants will consume 5 slices of conventional bread. The participants will then be asked to consume 5 slices per day of either conventional bread or bread made using an enzyme blend, for a period of 2 days each (order to be randomly allocated) and collect ileostomy digesta from the ileostomy bag every 2 hours from 7am to 11pm and then again at 7am. A washout period is not required. The ileostomy digesta samples will be obtained from the participant’s home by research staff and analysed in the laboratory for total protein and amino acid content. Throughout the 6 days of the study, participants will consume a low protein (0.65‐0.80g/kg BW/d) baseline diet (all foods will be provided) and asked to fill‐out food checklists for assessment of compliance. CONDITION: Gut health;Inadequate nutrition; ; Gut health ; Inadequate nutrition Oral and Gastrointestinal ‐ Inflammatory bowel disease PRIMARY OUTCOME: ileal proline digestibility (%) will be assessed by laboratory analysis of ileal digesta[48 hrs post commencement of consumption of each test bread] ileal protein digestibility (%) will be assessed by laboratory analysis of ileal digesta[48 hrs post commencement of consumption of each test bread] SECONDARY OUTCOME: nil[nil] INCLUSION CRITERIA: • Adult male or female • Aged 20‐80 years inclusive. • Health professional confirmation of minimal terminal ileum (up to 10 cm) removed more than 1 year ago and have a conventional and well‐functioning permanent ileostomy deemed fit for the study intervention (confirmed by GP). • Understand the study requirements, including digesta collections and willing to adhere closely to prescribed food consumption and alcohol restrictions as per the research protocol.
Epistemonikos ID: f6403e46017ded6e6fab7109d2ca39523771768a
First added on: Aug 24, 2024