None listed
Conditions
Brief summary
It is suggested that incomplete digestion of proline-rich proteins, including gluten, may be a cause of food intolerance and food allergies in some people, and lead to gut discomfort and distress. Foods containing these proline-rich proteins are widespread in our diet and are present in a broad range of foods. To improve the digestibility of the protein in these foods, Biohawk has developed a unique enzyme blend that can be added during food manufacturing. Anecdotal evidence suggests that bread made with gluten-rich flour treated with this enzyme blend is well tolerated by people who report having sensitivity to wheat-based products. However, independent testing is needed to confirm this, and to determine whether total protein and proline digestibility is improved. The main aim of this project is to evaluate the protein digestibility of bread products made from gluten-rich flour treated with an enzyme blend in healthy ileostomy participants.
Interventions
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 acclimat
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.
Sponsors
CSIRO Health and Biosecurity
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
20 Years to 80 Years
Healthy volunteers
No
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.
Exclusion criteria
• History of drug or alcohol abuse (i.e. > 14 serves alcohol/wk).* • History of smoking within the 6 months prior to the study. • Participation in a dietary intervention study within 30 days of commencement of this study. • A current presence of having gastrointestinal, renal, hepatic disease, coeliac disease, irritable bowel disease or, inflammatory bowel disease including Crohn’s disease and ulcerative colitis* • Use of any medication within the last 3 months that in the opinion of the investigator could interfere with the study or medications likely to modulate small intestinal function (See protocol for list of medications). • Definite or suspected personal history or family history of adverse events or intolerance to bread or foods made from wheat.* • Person considered by the investigator to be unwilling, unlikely or unable to comprehend or comply with the study protocol and restrictions. • Unwilling or unable to collect ileal effluent as required. * confirmed by trained Clinic Team Member; no clinical testing will be conducted to diagnose/confirm medical history.
Outcome results
None listed