Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000495426
Ethics application status
Approved
Date submitted
25/04/2025
Date registered
22/05/2025
Date last updated
22/05/2025
Date data sharing statement initially provided
22/05/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Incorporation of Evidence-Based Practical Dietary Therapy into Inflammatory Bowel Disease Care: The DELECTABLE Program
Scientific title
Assessment of satisfaction and adherence to Evidence-Based Practical Dietary Therapy in Inflammatory Bowel Disease Routine Care: The DELECTABLE Program
Secondary ID [1] 314292 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory Bowel Disease 337233 0
Condition category
Condition code
Oral and Gastrointestinal 333642 333642 0 0
Inflammatory bowel disease
Oral and Gastrointestinal 333712 333712 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dietitian-led, Open-label program of 3 dietary strategies as adjunctive therapy for Inflammatory Bowel Disease.

Dietary therapy will be offered to patients: the Crohn’s Disease Exclusion Diet (if the patient has Crohn’s or pouchitis), the Ulcerative Colitis diet (if the patient has UC or microscopic colitis), or a less restrictive wholefood diet that excludes ultra-processed food (for any condition).

The Crohn’s Disease Exclusion Diet (CDED)
The Crohn’s Disease Exclusion Diet (CDED) is a 3-phase diet. The diet mainly focuses on:
• Avoidance of added chemicals
• Inclusion of high-quality, low-fat protein (mostly chicken and eggs)
• Inclusion of resistant starch and specific fibres (apples, bananas, potatoes)
• Use of liquid supplements to help meet energy and nutrient needs

In addition, the diet limits dairy, wheat, oats, quinoa, red meat, and fish. These must be avoided entirely in the first six weeks and consumed in restricted amounts long term. Certain fruits and vegetables are also restricted in the initial phase of the diet. The diet becomes less restrictive as you move through the stages.
In brief:
• Phase 1: Follow for 6 weeks, every day consume 50% of your energy as liquid supplements, and eat eggs, chicken, potatoes, apples, and bananas daily. Plus, eat unlimited rice, rice noodles and limited amounts of some fruit and vegetables
• Phase 2: Follow for 6 weeks, every day consume 25% of your daily energy as liquid supplements and eat eggs, chicken, potatoes, apples, and bananas. Plus, eat unlimited rice, rice noodles, and start introducing some additional grains, fruits, and vegetables not allowed during phase 1.
• Phase 3: Follow longer-term, follow the CDED guidelines for 5 days of the week and consume some disallowed foods in moderation on the other 2 days.

The Ulcerative Colitis Diet
The researchers designed the ulcerative colitis diet.
The focus of this diet is:
• Avoid sulphur, sulphide-additives, sulphur-containing vegetables and sulphur-containing amino acids (cysteine, taurine, methionine).
• Reduction in saturated fats
• Provision of fermentable carbohydrates.

Like the wholefood diet, the Ulcerative Colitis diet limits intake of added chemicals in food.

The Wholefood Diet
This diet was designed by the researchers.

This diet's main focus is on excluding added chemicals in food. Most processed foods contain chemicals to make them look better, last longer, or taste different. Many of these chemicals, however, are known to be pro-inflammatory.

Natural (unprocessed) foods are allowed. Natural foods include fresh, chilled and frozen fruits and vegetables; legumes such as beans and lentils; nuts and seeds; fresh meat, poultry and fish; eggs; milk and some yoghurts. Grains, such as oats, rice, polenta, quinoa and flours/flakes/pastas made from grains are also considered natural, as although they have undergone some mechanical processing, they generally contain no chemical additives.

Processed food ingredients generally do not contain added chemicals and can be kept in the diet. These are usually used to cook fresh foods and are rarely consumed alone. Examples include olive and other vegetable oils (sunflower, canola, etc.), salt, sugar, honey and vinegar. Processed foods with these minor additions (i.e. salt, sugar, oil) but no chemicals can also be kept in the diet. Examples include some corn chips, potato crisps, nut butters, and certain crackers/breads/breakfast cereals.
Processed foods often contain additives to preserve their original properties or prevent spoilage. Examples include tinned vegetables and fruits, cured meats, cheese and bread. The labels of these foods need to be checked before deciding if they are safe to consume.


Adherence will be monitored using 24-hr diet recalls, a modified medication adherence scale, and the CDED adherence scale. Patients will have in-person or phone visits with the dietitian at Baseline, end of Week 1, End of Week 6, End of Week 12, 6 months and 12 months post-enrollment, with follow-up (completion of questionnaires) at 24, 36, 48 and 60 months. After 12 weeks, all patients will be transitioned to the wholefood diet. Patients will also be permitted to switch diet arms during the program, which will be recorded. Patients will follow their allocated diet arm for the entire duration that they are allocated to that diet (all meals and snacks).

Dietitians will provide education materials and a meal plan, but food will not be provided.
Intervention code [1] 330900 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341222 0
Diet Satisfaction Questionnaire (DSAT-28)
Timepoint [1] 341222 0
Week 12 post-intervention commencement
Primary outcome [2] 341223 0
Diet adherance
Timepoint [2] 341223 0
Week 12 post-intervention commencement
Secondary outcome [1] 446801 0
Disease activity (symptoms)
Timepoint [1] 446801 0
Week 12 post-intervention commencement
Secondary outcome [2] 446802 0
Disease activity (inflammation)
Timepoint [2] 446802 0
Week 12 post-intervention commencement
Secondary outcome [3] 446803 0
Quality of Life
Timepoint [3] 446803 0
Week 12 post-intervention commencement
Secondary outcome [4] 446804 0
Study specific questionnaire of need for increased IBD drug therapy
Timepoint [4] 446804 0
Week 12 post intervention commencement
Secondary outcome [5] 447070 0
Disease activity
Timepoint [5] 447070 0
12-week post commencment of study
Secondary outcome [6] 447072 0
Ability to decrease IBD drug therapy
Timepoint [6] 447072 0
12-week post commencement of intervention

Eligibility
Key inclusion criteria
• Inflammatory bowel disease patients with active or quiescent Inflammatory Bowel Disease (Crohn’s Disease, Ulcerative Colitis, Microscopic colitis or Pouchitis), previously diagnosed using validated diagnostic criteria
• Stated willingness to undertake long-term dietary changes as adjunctive therapy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Diagnosis of DSM-defined eating disorder
• Acute bowel obstruction requiring urgent surgical intervention
• Inability to give informed consent
• Inability to understand or follow dietary guidelines
• Suspected perforation of the gastrointestinal tract

Study design
Purpose of the study
Treatment
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Categorical variables will be applied to chi-squared tests (or Fisher's Exact tests for small samples) while continuous variables will be applied to (parametric) two tailed t-tests and (non-parametric) Mann-Whitney/Kruskal-Wallis tests for symmetrically and asymmetrically distributed data, respectively.
Confounding and allocation bias will be minimised. Information bias will be minimised by blinding the assessment of the outcomes to patient identity by the central principal investigators. Furthermore, strict and objective criteria will be used for outcome ascertainment (that is, to define the clinical response). Data will be reported according to the STROBE-nut Statement

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/11/2021
Date of last participant enrolment
Anticipated
Actual
28/02/2023
Date of last data collection
Anticipated
Actual
15/02/2025
Sample size
Target
100
Accrual to date
Final
67
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 318809 0
Charities/Societies/Foundations
Name [1] 318809 0
Australasian Gastro Intestinal Research Foundation (AGIRF)
Country [1] 318809 0
Australia
Funding source category [2] 318866 0
Charities/Societies/Foundations
Name [2] 318866 0
Charitable donation from The Yencken Family
Country [2] 318866 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital
Address
Country
Australia
Secondary sponsor category [1] 321255 0
None
Name [1] 321255 0
Address [1] 321255 0
Country [1] 321255 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317420 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 317420 0
Ethics committee country [1] 317420 0
Australia
Date submitted for ethics approval [1] 317420 0
01/09/2020
Approval date [1] 317420 0
09/10/2020
Ethics approval number [1] 317420 0
66559

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

Contacts
Principal investigator
Name 140998 0
Prof Michael A Kamm
Address 140998 0
St Vincents Hospital, 55 Victoria Parade, Fitzroy, Melbourne, Victoria, 3065
Country 140998 0
Australia
Phone 140998 0
+61 3 9417 5064
Fax 140998 0
Email 140998 0
[email protected]
Contact person for public queries
Name 140999 0
Michael A Kamm
Address 140999 0
St Vincents Hospital, 55 Victoria Parade, Fitzroy, Melbourne, Victoria, 3065
Country 140999 0
Australia
Phone 140999 0
+61 3 9417 5064
Fax 140999 0
Email 140999 0
[email protected]
Contact person for scientific queries
Name 141000 0
Michael A Kamm
Address 141000 0
St Vincents Hospital, 55 Victoria Parade, Fitzroy, Melbourne, Victoria, 30635
Country 141000 0
Australia
Phone 141000 0
+61 3 9417 5064
Fax 141000 0
Email 141000 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Sensitive data



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.