Comparison of protein quality of foods made from different plant sources

Category Primary study
Registry of TrialsANZCTR
Year 2022
INTERVENTION: The pilot study will be designed as a randomised, double‐blinded, controlled cross‐over intervention. A total of 4 proctocolectomised adults with conventional and well‐functioning permanent ileostomies will be recruited The study will be conducted over 2 weeks within the participant’s home. This will comprise 4 testing days each week, for 2 weeks. On each testing day, they will consume 2 test muffins or protein‐free biscuits in the morning (breakfast and morning tea) and a standardised lunch, afternoon tea and dinner will be provided. Each study participant will consume each test food (4 in total) on 2 consecutive days. The test foods are 3 different protein‐containing muffins and a protein‐free biscuit. The test muffins will be made using a muffin recipe using wheat flour and for 2 of the test muffins 50% of the flour will be substituted with soy or lupin flour. The order of the treatment will be randomly assigned across the 2‐week testing period following a 4 X4 Latin Square (4 possible sequences are ABCD, BCDA, CDAB and DABC). On each test day, participants will consume two test muffins or protein free biscuits in the morning (8am and 10am) and then collect ileostomy digesta over the 24 hr period following consumption of the first test muffin (8am to 8am). The digesta samples will be collected from the participant’s home by Research staff and analysed in the laboratory for analysis (protein and amino acid content). Participants will complete a daily log via a paper‐based diary to assess protocol compliance, adverse events and use of concomitant medications. Any queries that arise from the surveys will be followed up by a phone call or email. The digestibility of the foods will be compared between the humans and in vitro digestibility (INFOGEST) usin CONDITION: Oral and Gastrointestinal ‐ Normal oral and gastrointestinal development and function Protein digestion; ; Protein digestion PRIMARY OUTCOME: True amino acid digestibility of the three different test muffins. ; True protein/amino acid digestibility will be determined for the test muffins by calculating the amino acid content difference between the test meal and the ileal digesta contents and correcting this data using protein excretion data obtained following consumption of the protein free biscuit (measure of endogenous amino acid excretion). This provides an indication of the availability of the amino acids in the protein source.[Digesta will be collected through the ileostomies by the participants for a period of 10 hours after the test muffins have been consumed. They will empty their ostomy bags (collecting the contents every 2 hours during this 10‐hour period and pooled sub‐samples will over this time period will be analysed.] SECONDARY OUTCOME: Total protein digestibility of the three different test muffins. ; The proportion of the consumed protein that passes through the digestive tract (mouth to end of terminal ileum) over the 10‐hour sampling period will be determined.[Digesta will be collected through the ileostomies by the participants for a period of 10 hours after the test muffins have been consumed. They will empty their ostomy bags (collecting the contents every 2 hours during this 10‐hour period and pooled sub‐samples, over this time period, will be analysed..] INCLUSION CRITERIA: 1. Adult male or female 2. Aged 20‐80 years inclusive. 3. 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). 4. Understand the study requirements, including digesta collections and willing to adhere closely to consuming the prescribed food and drinks as per the research protocol.
Epistemonikos ID: 2dbcb31943121a21e80a84fb56708ccb58450d4e
First added on: Aug 26, 2024