None listed
Conditions
Brief summary
This study aims to investigate the therapeutic appearance, nutritional content and participant acceptability of a sham dietary prescription in healthy individuals. The intent of the sham diet is to have the appearance of a therapeutic diet by excluding or substituting inert food items without altering overall nutrient intake compared to habitual diet. The sham diet has been designed for future use in placebo-controlled dietary advice trials for ulcerative colitis.
Interventions
A research dietitian will provide sham dietary advice including a 20-minute verbal dietary education, a diet manual, recipes and a comprehensive 3-day meal plan to 10-20 healthy adults. These resources have been specifically designed for this trial. The sham diet and dietary advice provided has been developed to mirror the level of complexity and appearance of the experimental diet that has been designed for future use in a randomised, placebo-controlled trial. The nutritional prescription is m
A research dietitian will provide sham dietary advice including a 20-minute verbal dietary education, a diet manual, recipes and a comprehensive 3-day meal plan to 10-20 healthy adults. These resources have been specifically designed for this trial. The sham diet and dietary advice provided has been developed to mirror the level of complexity and appearance of the experimental diet that has been designed for future use in a randomised, placebo-controlled trial. The nutritional prescription is modelled on a typical Australian dietary intake. Participants will be counselled during a one-on-one face-to-face consult on following the dietary advice for 7 days. Adherence to the diet will be evaluated using a 3-day weighed food diary.
Sponsors
The Queen Elizabeth Hospital, Central Adelaide Local Health Network
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Must meet all of the following criteria: 1] Healthy adults greater than or equal to 18 years of age 2] Not aware of the prescribed intervention diet
Exclusion criteria
If any one of the following criteria is met, healthy individuals are excluded from the study: 1] Diagnosis inflammatory bowel disease 2] Diagnosis of any other gastrointestinal condition with known dietary intervention as treatment (e.g. coeliac disease, eosinophilic esophagitis, irritable bowel syndrome) 3] Pregnant or breastfeeding 4] Significant medical comorbidities that require a therapeutic diet 5] Significant cognitive/psychiatric conditions 6] Prior gastrointestinal surgery 7] Taking medications known to alter bowel function 8] Evidence of active infection and/or those requiring current antibiotic therapy 9] Habitually following a vegan or vegetarian diet 10] Habitually following a popularised diet for perceived health or weight loss benefits 11] Unable to provide informed consent 12] Enrolled in any other trial
Outcome results
None listed