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Trial registered on ANZCTR


Registration number
ACTRN12624001489583
Ethics application status
Approved
Date submitted
18/11/2024
Date registered
20/12/2024
Date last updated
20/12/2024
Date data sharing statement initially provided
20/12/2024
Date results provided
20/12/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating a sham diet for food-based interventional trials in ulcerative colitis
Scientific title
Evaluating a sham diet in healthy volunteers for food-based interventional trials in ulcerative colitis
Secondary ID [1] 313404 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative colitis 335780 0
Condition category
Condition code
Oral and Gastrointestinal 332354 332354 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 329979 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339913 0
Composite primary outcome: Therapeutic appearance and success of blinding of the sham diet
Timepoint [1] 339913 0
End of week 1
Secondary outcome [1] 441894 0
Acceptability
Timepoint [1] 441894 0
End of week 1
Secondary outcome [2] 441895 0
Dietary adherence
Timepoint [2] 441895 0
End of week 1
Secondary outcome [3] 441896 0
Tolerability
Timepoint [3] 441896 0
End of week 1
Secondary outcome [4] 441897 0
Change in stool consistency
Timepoint [4] 441897 0
Baseline and end of week 1
Secondary outcome [5] 441898 0
Change in bowel function
Timepoint [5] 441898 0
Baseline and end of week 1
Secondary outcome [6] 441900 0
Dietary intake
Timepoint [6] 441900 0
Baseline and end of week 1
Secondary outcome [7] 442630 0
Ease of preparation of diet
Timepoint [7] 442630 0
End of week 1
Secondary outcome [8] 442631 0
Ease of purchasing diet
Timepoint [8] 442631 0
End of week 1
Secondary outcome [9] 442632 0
Overall ease of following sham diet
Timepoint [9] 442632 0
End of week 1
Secondary outcome [10] 442633 0
Overall tolerability of sham diet
Timepoint [10] 442633 0
End of week 1

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/03/2021
Date of last participant enrolment
Anticipated
Actual
21/07/2021
Date of last data collection
Anticipated
Actual
29/07/2021
Sample size
Target
12
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 317846 0
Charities/Societies/Foundations
Name [1] 317846 0
The Hospital Research Foundation Project Grant
Country [1] 317846 0
Australia
Primary sponsor type
Hospital
Name
The Queen Elizabeth Hospital, Central Adelaide Local Health Network
Address
Country
Australia
Secondary sponsor category [1] 320176 0
University
Name [1] 320176 0
University of Adelaide
Address [1] 320176 0
Country [1] 320176 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316527 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 316527 0
Ethics committee country [1] 316527 0
Australia
Date submitted for ethics approval [1] 316527 0
01/07/2020
Approval date [1] 316527 0
15/10/2020
Ethics approval number [1] 316527 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138166 0
Dr Alice Day
Address 138166 0
Department of Gastroenterology, The Queen Elizabeth Hospital, 28 Woodville Road, Woodville South, South Australia 5011
Country 138166 0
Australia
Phone 138166 0
+61 413550112
Fax 138166 0
Email 138166 0
Alice.Day@sa.gov.au
Contact person for public queries
Name 138167 0
Alice Day
Address 138167 0
Department of Gastroenterology, The Queen Elizabeth Hospital, 28 Woodville Road, Woodville South, South Australia 5011
Country 138167 0
Australia
Phone 138167 0
+61 8 8222 6486
Fax 138167 0
Email 138167 0
Health.IBDresearchteam@sa.gov.au
Contact person for scientific queries
Name 138168 0
Alice Day
Address 138168 0
Department of Gastroenterology, The Queen Elizabeth Hospital, 28 Woodville Road, Woodville South, South Australia 5011
Country 138168 0
Australia
Phone 138168 0
+61 413550112
Fax 138168 0
Email 138168 0
Alice.Day@sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not required


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.