Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001090606
Ethics application status
Approved
Date submitted
13/09/2023
Date registered
17/10/2023
Date last updated
17/10/2023
Date data sharing statement initially provided
17/10/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Apple and Colitis study (AppleCo)
Scientific title
The effects of consuming a heritage apple on markers of inflammation in patients with ulcerative colitis: The AppleCo study
Secondary ID [1] 310590 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
ulcerative colitis 331451 0
Condition category
Condition code
Inflammatory and Immune System 328189 328189 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 328293 328293 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is an intervention study conducted to assess the effects of apple on gastrointestinal symptoms and disease activity in patients with ulcerative colitis. Eligible participants will be monitored for disease activity and symptoms for 6-weeks. Additionally, for 2-weeks starting from week 3 of the study, An experienced nutrition researcher will ask the participants to consume a ~250g apple study product provided, daily.
The apple study product will be stored in ~250g amounts, pre-prepared in Massey University's product development lab or pilot plant, under strict hygiene conditions and released for consumption. At the beginning of week 3 and Week 4, participants will be given 1-week supply of the study product to store in their freezers and consume the content of one product pack per day. Participants will complete 24-hour recall diaries daily and return all study product packaging to the research unit to assess adherence.
Weekly: Participants will be asked to complete online questionnaires through a secure data management platform (RedCAP) and fecal samples will be collected.
Intervention code [1] 326996 0
Lifestyle
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336069 0
Intestinal inflammation assessed by fecal calprotectin
Timepoint [1] 336069 0
Weekly for 6 weeks post-enrollment
Secondary outcome [1] 426731 0
Quality of Life: Crohn's and Ulcerative Colitis Questionnaire-32 (CUCQ-32)

Timepoint [1] 426731 0
Fortnightly for 6 weeks post-enrollment
Secondary outcome [2] 426732 0
Faecal short chain fatty acids
Timepoint [2] 426732 0
Baseline and 5 weeks post-enrollment
Secondary outcome [3] 426733 0
Gut microbiota determined by 16s RNA of faecal samples
Timepoint [3] 426733 0
Baseline, 5 weeks and 6 weeks post-enrolment
Secondary outcome [4] 427163 0
IBD symptoms (IBDSI-SF) score
Timepoint [4] 427163 0
Weekly for 6 weeks post-enrollment
Secondary outcome [5] 427164 0
Functional gastrointestinal symptoms score (GSRS)
Timepoint [5] 427164 0
Weekly for 6 weeks post-enrollment

Eligibility
Key inclusion criteria
• Established diagnosis of UC for at least 6-months
• Faecal calprotectin of greater than 200 µg/g
• male or female aged between 18 and 60
• Ability to complete web-based questionnaires in English
• Must have an email address and access to a computer and internet. Must have time to complete online weekly questionnaires (~30 minutes each).
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Those who are in remission (P-SCCAI score less than or equal to 2) and disease inactive (MIBDI score)
• Those with severe disease activity
• History of colectomy, total colectomy or colostomy
• Probiotic use
• Pregnant or breast feeding
• Known allergies or hypersensitivity to apples.
• Any significant comorbidities
• Antibiotic therapy in the last 4 weeks prior to inclusion into the study

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/10/2023
Actual
Date of last participant enrolment
Anticipated
31/01/2024
Actual
Date of last data collection
Anticipated
31/03/2024
Actual
Sample size
Target
42
Accrual to date
Final
Recruitment outside Australia
Country [1] 25768 0
New Zealand
State/province [1] 25768 0
Palmerston North

Funding & Sponsors
Funding source category [1] 314798 0
University
Name [1] 314798 0
Massey University
Country [1] 314798 0
New Zealand
Funding source category [2] 314801 0
Charities/Societies/Foundations
Name [2] 314801 0
Heritage Food Crop Research Trust
Country [2] 314801 0
New Zealand
Primary sponsor type
Individual
Name
Noha Nasef
Address
Tennent drive, Palmerston North, 4442
Country
New Zealand
Secondary sponsor category [1] 316789 0
None
Name [1] 316789 0
Address [1] 316789 0
Country [1] 316789 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313810 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 313810 0
PO Box 5013, Wellington 6140
Ethics committee country [1] 313810 0
New Zealand
Date submitted for ethics approval [1] 313810 0
31/07/2023
Approval date [1] 313810 0
13/09/2023
Ethics approval number [1] 313810 0
2023 EXP 15519

Summary
Brief summary
Inflammation and disturbances in the gut microbiota (dysbiosis) are hallmarks of a disease affecting the intestine known as Inflammatory Bowel Disease (IBD). IBD is broadly classified into two main subtypes based on the regions of the intestine affected: Crohn’s disease (CD) and Ulcerative colitis (UC). Both subtypes of IBD are likely to be influenced by diet, however, most studies on dietary supplementation show benefit in UC.
Apples are an excellent example of a commonly consumed low-cost fruit grown in NZ and globally that could have potential benefits in IBD. Animal studies show that apple extracts can reduce pathological parameters of the disease. In this study, we will be using an apple product created from a heritage apple variety known as Monty's surprise, that has higher phytochemical concentrations compared to commercial apple varieties.
We will be conducting a pilot intervention study with UC participants.
Aims:
- To assess changes in gut inflammation
- To assess changes in disease activity and quality of life
- To assess changes in the gut microbiota and short chain fatty acid production
- To assess whether the participant's genetic profile influences their response to treatment (personalized nutrition)
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129418 0
Dr Noha Nasef
Address 129418 0
Massey University, Tennent Drive, Palmerston North, 4442
Country 129418 0
New Zealand
Phone 129418 0
+64 6 9519421
Fax 129418 0
Email 129418 0
n.nasef@massey.ac.nz
Contact person for public queries
Name 129419 0
Dr Noha Nasef
Address 129419 0
Massey University, Tennent Drive, Palmerston North, 4442
Country 129419 0
New Zealand
Phone 129419 0
+64 6 9519421
Fax 129419 0
Email 129419 0
n.nasef@massey.ac.nz
Contact person for scientific queries
Name 129420 0
Dr Noha Nasef
Address 129420 0
Massey University, Tennent Drive, Palmerston North, 4442
Country 129420 0
New Zealand
Phone 129420 0
+64 6 9519421
Fax 129420 0
Email 129420 0
n.nasef@massey.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.