Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000916549
Ethics application status
Approved
Date submitted
12/06/2024
Date registered
29/07/2024
Date last updated
15/12/2024
Date data sharing statement initially provided
29/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating a novel therapeutic diet for ulcerative colitis
Scientific title
Investigating a novel therapeutic diet on food additives for ulcerative colitis in adults - The INNOVATE Study
Secondary ID [1] 312243 0
Nil known
Universal Trial Number (UTN)
Nil known
Trial acronym
INNOVATE STUDY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 334083 0
Condition category
Condition code
Oral and Gastrointestinal 330761 330761 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There will be 2 dietary arms, each administered for 4-weeks.

The intervention arm is a diet low in sulphate-containing food additives. All food will be in collaboration with the study dietitian and provided to study participants for the duration of the study. The main meals will be delivered frozen to participants each week by an external meal delivery service. Examples of meals will include pasta, stir fry in rice. Participants will be instructed to consume only study meals provided and abstain from any food outside of the diet.

The study will include 3 in-person study visits, each lasting approx 2 h, which will all be conducted and managed at the Alfred Hospital and Monash University that is co-located at the Alfred Research Alliance Precinct. The study visits will involve meeting with the principal investigator, study gastroenterologist and study dietitian (all of whom have more than 5 years experience). Instructions will be provided for compliance to the diet intervention.

Adherence to the diets will be recorded in food diaries containing daily checkboxes to ensure participants are having the correct provided meals and an additional space to write down any meals or snacks ingested outside the diet.
Intervention code [1] 328806 0
Treatment: Other
Comparator / control treatment
Participants will be informed that they will not be told which diet they are receiving, but that their study coordinator will (single-blinded). Participants will be informed that the study is looking at certain food components that previous studies suggest might help, and that early research with people who have mild to moderate ulcerative colitis shows promising signs.

The sham diet will be low in selected food additives in confectionary, snack products and selected condiments. This diet will differ only in the types of food additives that are restricted, and will avoid consumption of additives commonly present in selected brands of confectionary, condiments and snack foods. All food provided are every day foods found in the supermarket and already consumed in the community.

Both the intervention and sham diet will be matched for macronutrients (including animal protein), fermentable carbohydrates (FODMAPs), fibre including resistant starch and naturally occurring sulphates.

Similar to the intervention arm, this diet will be provided for 4-weeks and all meals will be delivered frozen to the participant. Examples of meals will include pasta, stir fry in rice.
Control group
Placebo

Outcomes
Primary outcome [1] 338522 0
Change in faecal calprotectin as a marker of colonic inflammation
Timepoint [1] 338522 0
Baseline and end of 4-week treatment
Secondary outcome [1] 436260 0
Proportion of patients demonstrating disease response
Timepoint [1] 436260 0
Baseline and end of 4-week treatment
Secondary outcome [2] 436261 0
Proportion of patients in remission
Timepoint [2] 436261 0
Baseline and end of 4-week treatment
Secondary outcome [3] 436262 0
Change in disease activity
Timepoint [3] 436262 0
Baseline and end of 4-week treatment
Secondary outcome [4] 436265 0
Change in patient-reported clinical outcomes
Timepoint [4] 436265 0
Baseline and end of 4-week treatment
Secondary outcome [5] 436266 0
Change in fat free mass
Timepoint [5] 436266 0
Baseline and end of 4-week treatment
Secondary outcome [6] 436269 0
Change in intestinal barrier dysfunction
Timepoint [6] 436269 0
Baseline and end of 4-week treatment
Secondary outcome [7] 436272 0
Change in colonic protein fermentation end-products
Timepoint [7] 436272 0
Baseline and end of 4-week treatment
Secondary outcome [8] 436273 0
Change in markers of sulphate metabolism
Timepoint [8] 436273 0
Baseline and end of 4-week treatment
Secondary outcome [9] 436274 0
Tolerability of diet
Timepoint [9] 436274 0
Baseline and weekly throughout 4-week treatment
Secondary outcome [10] 436833 0
Changes in depression and anxiety scores
Timepoint [10] 436833 0
Baseline and weekly throughout 4-week treatment
Secondary outcome [11] 436841 0
Change in intestinal barrier dysfunction
Timepoint [11] 436841 0
Baseline and at the end of 4 weeks
Secondary outcome [12] 437653 0
Change in fat mass
Timepoint [12] 437653 0
Baseline and weekly throughout 4-week treatment

Eligibility
Key inclusion criteria
- mild to moderate ulcerative colitis
- active disease (either left-sided or extensive UC) as evidenced sonographically, faecal calprotectin >250 and where available, endoscopy results performed in the last 3 months indicate total Mayo score of 3-10
- on stable medical therapy for >1 month
- naïve to formal dietetic intervention
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Severe UC, indeterminate colitis or Crohn’s disease
- Presence of other GI co-morbidities (e.g. coeliac disease)
- Presence of clinically significant haematological abnormalities
- Prior gastrointestinal surgeries
- Pregnancy, trying to get pregnant and breastfeeding
- Current use of corticosteroids
- Dietary restrictions, food allergies, intolerances or aversions, that would interfere with consuming intervention foods (e.g. food allergy, veganism, lacto-ovo vegetarianism)
- Individuals not on a stable diet for at least 4 weeks

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed at time of screening, and only study personnel directly involved with coordinating diet provision for participants will be aware of treatment assignment. Both patients and the study gastroenterologist performing intestinal ultrasound end-points will be blinded.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2024
Actual
7/08/2024
Date of last participant enrolment
Anticipated
30/06/2025
Actual
Date of last data collection
Anticipated
18/08/2025
Actual
Sample size
Target
32
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 316620 0
Charities/Societies/Foundations
Name [1] 316620 0
Gastroenterological Society of Australia
Country [1] 316620 0
Australia
Primary sponsor type
Hospital
Name
Alfred Health
Address
Country
Australia
Secondary sponsor category [1] 318806 0
University
Name [1] 318806 0
Monash University
Address [1] 318806 0
Country [1] 318806 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315405 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 315405 0
Ethics committee country [1] 315405 0
Australia
Date submitted for ethics approval [1] 315405 0
27/03/2024
Approval date [1] 315405 0
10/05/2024
Ethics approval number [1] 315405 0
106283

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

Contacts
Principal investigator
Name 134602 0
Dr Chu K Yao
Address 134602 0
Department of Gastroenterology School of Translational Medicine, Monash University/The Alfred Level 6 Alfred Centre Commercial Road, Prahran VIC 3004
Country 134602 0
Australia
Phone 134602 0
+61 3 99030266
Fax 134602 0
Email 134602 0
chu.yao@monash.edu
Contact person for public queries
Name 134603 0
Chu K Yao
Address 134603 0
Department of Gastroenterology School of Translational Medicine, Monash University/The Alfred Level 6 Alfred Centre Commercial Road, Prahran VIC 3004
Country 134603 0
Australia
Phone 134603 0
+61 3 99030266
Fax 134603 0
Email 134603 0
chu.yao@monash.edu
Contact person for scientific queries
Name 134604 0
Chu K Yao
Address 134604 0
Department of Gastroenterology School of Translational Medicine, Monash University/The Alfred Level 6 Alfred Centre Commercial Road, Prahran VIC 3004
Country 134604 0
Australia
Phone 134604 0
+61 3 99030266
Fax 134604 0
Email 134604 0
chu.yao@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
Immediately following publication, no end date.
Available to whom?
Individual research results will only be made upon request to the study investigators. This has been included in the PICF.
Available for what types of analyses?
Only to achieve the aims in the approved proposal submitted in the request.
How or where can data be obtained?
Access subject to approvals by Principal Investigator:
Dr CK Yao
Translational Nutritional Sciences
Department of Gastroenterology
School of Translational Medicine
Monash University/The Alfred
Level 6 Alfred Centre
Commercial Road,
Prahran VIC 3004
Email: chu.yao@monash.edu


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.