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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
29/07/2024
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
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Scientific title
Investigating a novel therapeutic diet on food additives for ulcerative colitis in adults - The INNOVATE Study
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Secondary ID [1]
312243
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Nil known
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Universal Trial Number (UTN)
Nil known
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Trial acronym
INNOVATE STUDY
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis
334083
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Condition category
Condition code
Oral and Gastrointestinal
330761
330761
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0
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Inflammatory bowel disease
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
328806
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Treatment: Other
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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.
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Control group
Placebo
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Outcomes
Primary outcome [1]
338522
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Change in faecal calprotectin as a marker of colonic inflammation
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Assessment method [1]
338522
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Stool samples will be analysed for calprotectin concentrations using Calpro Easy Extract device and via Enzyme-linked Immunosorbent Assay (ELISA) kit (CAL0100, CALPRO AS; Lysaker).
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Timepoint [1]
338522
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Baseline and end of 4-week treatment
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Secondary outcome [1]
436260
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Proportion of patients demonstrating disease response
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Assessment method [1]
436260
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Disease response assessed using reduction in faecal calprotectin by 50% compared to baseline, sonographic response defined as reduction in bowel wall thickness (BWT) >0.5 mm and improvement in vascularity by at least one grade (1), and reduction in greater than or equal to 2 points on Partial Mayo Score.
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Timepoint [1]
436260
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Baseline and end of 4-week treatment
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Secondary outcome [2]
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Proportion of patients in remission
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Assessment method [2]
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Remission defined as faecal calprotectin greater than or equal to 150 ug/g, sonographic remission – BWT <3mm and no evidence of hyperaemia, and Partial Mayo Score less than or equal to 1
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Timepoint [2]
436261
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Baseline and end of 4-week treatment
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Secondary outcome [3]
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Change in disease activity
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Assessment method [3]
436262
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Changes in clinical indices, Partial Mayo Score Index
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Timepoint [3]
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Baseline and end of 4-week treatment
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Secondary outcome [4]
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Change in patient-reported clinical outcomes
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Assessment method [4]
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IBD-Control-8 Questionnaire
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Timepoint [4]
436265
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Baseline and end of 4-week treatment
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Secondary outcome [5]
436266
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Change in fat free mass
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Assessment method [5]
436266
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Bioimpedance analysis
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Timepoint [5]
436266
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Baseline and end of 4-week treatment
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Secondary outcome [6]
436269
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Change in intestinal barrier dysfunction
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Assessment method [6]
436269
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Changes in plasma lipopolysaccharide binding protein (LPB) concentrations
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Timepoint [6]
436269
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Baseline and end of 4-week treatment
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Secondary outcome [7]
436272
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Change in colonic protein fermentation end-products
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Assessment method [7]
436272
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Branched chain fatty acids
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Timepoint [7]
436272
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Baseline and end of 4-week treatment
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Secondary outcome [8]
436273
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Change in markers of sulphate metabolism
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Assessment method [8]
436273
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Faecal sulphide concentrations
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Timepoint [8]
436273
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Baseline and end of 4-week treatment
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Secondary outcome [9]
436274
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Tolerability of diet
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Assessment method [9]
436274
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Tolerability and acceptability questionnaire (non-validated but wording used in our previous dietary trial research that has also assessed design of novel diets).
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Timepoint [9]
436274
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Baseline and weekly throughout 4-week treatment
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Secondary outcome [10]
436833
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Changes in depression and anxiety scores
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Assessment method [10]
436833
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DASS-21 questionnaire
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Timepoint [10]
436833
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Baseline and weekly throughout 4-week treatment
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Secondary outcome [11]
436841
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Change in intestinal barrier dysfunction
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Assessment method [11]
436841
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Plasma soluble CD14 concentrations
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Timepoint [11]
436841
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Baseline and at the end of 4 weeks
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Secondary outcome [12]
437653
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Change in fat mass
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Assessment method [12]
437653
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Bioimpedance analysis
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Timepoint [12]
437653
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Baseline and weekly throughout 4-week treatment
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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
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/08/2024
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Actual
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Date of last participant enrolment
Anticipated
30/06/2025
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Actual
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Date of last data collection
Anticipated
18/08/2025
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Actual
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Sample size
Target
32
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
316620
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Charities/Societies/Foundations
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Name [1]
316620
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Gastroenterological Society of Australia
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Address [1]
316620
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Country [1]
316620
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Australia
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Funding source category [2]
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Charities/Societies/Foundations
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Name [2]
316730
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Crohn’s Colitis of Australia
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Address [2]
316730
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Country [2]
316730
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Australia
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Primary sponsor type
Hospital
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Name
Alfred Health
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Address
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Country
Australia
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Secondary sponsor category [1]
318806
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University
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Name [1]
318806
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Monash University
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Address [1]
318806
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Country [1]
318806
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315405
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Alfred Hospital Ethics Committee
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Ethics committee address [1]
315405
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https://www.alfredhealth.org.au/research/ethics-research-governance
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Ethics committee country [1]
315405
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Australia
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Date submitted for ethics approval [1]
315405
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27/03/2024
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Approval date [1]
315405
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10/05/2024
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Ethics approval number [1]
315405
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106283
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Summary
Brief summary
Ulcerative colitis (UC) is a common debilitating chronic inflammatory bowel disease (IBD) of the large intestine, entailing inflammation and ulcerations in the lining of the large bowel. Recent research has shown that diet may play a role in contributing to the cause of gut inflammation involved in UC, and altering the diet may help manage UC. Therefore, we are investigating a new interventional diet to determine its clinical effects in UC. The results of this study will be able to help design dietary therapies to manage ulcerative colitis, especially as there is little information about the effect of diet on UC in humans. Hence, this study will conduct a 4-week long feeding study, where participants with diagnosed mild-to-moderate UC will be randomly given 1 of 2 diets: the intervention diet or a sham diet. All meals, including breakfast, lunch and dinner, and snacks for each diet will be provided to the participant. Blood and faecal samples will be collected, and participants will complete surveys to allow us to measure the effects of the new interventional diet on large bowel inflammation, changes in symptoms, quality of life and psychological well-being of UC, compared to the sham diet.
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Trial website
https://www.monash.edu/medicine/translational/clinical-trials/the-innovate-study
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
134602
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Dr Chu K Yao
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Address
134602
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Department of Gastroenterology School of Translational Medicine, Monash University/The Alfred Level 6 Alfred Centre Commercial Road, Prahran VIC 3004
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Country
134602
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Australia
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Phone
134602
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+61 3 99030266
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Fax
134602
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Email
134602
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[email protected]
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Contact person for public queries
Name
134603
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Chu K Yao
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Address
134603
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Department of Gastroenterology School of Translational Medicine, Monash University/The Alfred Level 6 Alfred Centre Commercial Road, Prahran VIC 3004
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Country
134603
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Australia
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Phone
134603
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+61 3 99030266
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Fax
134603
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Email
134603
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[email protected]
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Contact person for scientific queries
Name
134604
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Chu K Yao
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Address
134604
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Department of Gastroenterology School of Translational Medicine, Monash University/The Alfred Level 6 Alfred Centre Commercial Road, Prahran VIC 3004
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Country
134604
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Australia
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Phone
134604
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+61 3 99030266
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Fax
134604
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Email
134604
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification.
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When will data be available (start and end dates)?
Immediately following publication, no end date.
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Available to whom?
Individual research results will only be made upon request to the study investigators. This has been included in the PICF.
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Available for what types of analyses?
Only to achieve the aims in the approved proposal submitted in the request.
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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:
[email protected]
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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.
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