Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000655448
Ethics application status
Approved
Date submitted
17/05/2025
Date registered
20/06/2025
Date last updated
20/06/2025
Date data sharing statement initially provided
20/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
The 4F study - fibre-fortified foods & fluids for Aged Residential Care (ARC) in Aotearoa New Zealand
Scientific title
The Feasibility of Fibre-Fortified Foods & Fluids in Aged Residential Care (ARC) in Aotearoa New Zealand (4F)
Secondary ID [1] 314301 0
n/a
Universal Trial Number (UTN)
U1111-1321-9839
Trial acronym
4F
Linked study record

Health condition
Health condition(s) or problem(s) studied:
low dietary fibre intake 337246 0
constipation 337244 0
Condition category
Condition code
Diet and Nutrition 333653 333653 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Setting: New Zealand aged residential care facilities
Population: residents who are able to provide informed consent
Intervention: Introduction of a prebiotic soluble fibre (Nutriose (soluble maize fibre) & Digesten (kiwifruit enzyme active)). The dietary fibre supplement will be gradually introduced over a 1-week period with a 4-week maintenance phase at optimal dosage.(The optimal required dose is that which provides regular soft, easy to pass bowel motions, but should not exceed the maximum dose of two teaspoons twice daily.)
Strength/dose: 2 tsp (3g of fibre)
Frequency: The supplement dose will be provided twice daily (morning and evening)at meal times
Mode of administration: water soluble powder mixed into non-carbonated fluids or moist foods (e.g. soup/yoghurt)
Adherence: dosage, frequency and consumption of fibre the fortified supplement will be recorded on the Fibre Supplement Consumption Chart (DF-FORM08 )
Oversight of intervention: Registered Nurses and Dietitians
Intervention code [1] 331097 0
Treatment: Other
Comparator / control treatment
Participants act as their own control - there is a 1-2 week baseline period where baseline demographic and health data is collected along with monitoring of study outcomes.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341783 0
Bowel Classification
Timepoint [1] 341783 0
Daily during all three phases - baseline, introduction and maintenance phases
Primary outcome [2] 341505 0
Bowel frequency
Timepoint [2] 341505 0
Daily during all three phases - baseline, introduction and maintenance phases
Primary outcome [3] 341504 0
Laxative Use
Timepoint [3] 341504 0
Recording will occur daily during all three phases - baseline, introduction and maintenance phases
Secondary outcome [1] 448657 0
Fluid intake
Timepoint [1] 448657 0
once at baseline and once during the maintenance phase (2 x 2-day periods in total)
Secondary outcome [2] 447795 0
Food Intake
Timepoint [2] 447795 0
once at baseline and once during the maintenance phase (2 x 2-day periods in total
Secondary outcome [3] 447798 0
Feasibility of fibre supplement administration
Timepoint [3] 447798 0
At the conclusion of the study in each facility by individual staff members

Eligibility
Key inclusion criteria
• Residents of aged residential care facilities in NZ.
• Able to provide informed consent
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Unable to provide informed consent
• Taking antibiotics at the time of enrolment
• Using tobacco
• Parenteral or enteral feeding, not including the use of oral nutritional supplements
• Prior surgeries of the gastrointestinal tract (e.g. short bowel, bowel resections)
• Primary neurological causes of gastrointestinal issues, such as a spinal cord injury
• Obstructive or motility-related constipation.
• Allergy to fibre supplement ingredients (PrebiolaxTM) ingredients (e.g. kiwifruit).

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
Single group
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
23/06/2025
Actual
Date of last participant enrolment
Anticipated
19/12/2025
Actual
Date of last data collection
Anticipated
31/01/2026
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 27069 0
New Zealand
State/province [1] 27069 0
Auckland

Funding & Sponsors
Funding source category [1] 318822 0
University
Name [1] 318822 0
University of Auckland Student Research Fund
Country [1] 318822 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
McLeod Nutrition
Address
Country
New Zealand
Secondary sponsor category [1] 321476 0
None
Name [1] 321476 0
Address [1] 321476 0
Country [1] 321476 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317438 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 317438 0
Ethics committee country [1] 317438 0
New Zealand
Date submitted for ethics approval [1] 317438 0
24/04/2025
Approval date [1] 317438 0
12/06/2025
Ethics approval number [1] 317438 0
22420

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

Contacts
Principal investigator
Name 141030 0
Dr Sue MacDonell
Address 141030 0
Department of Nutrition & Dietetics, University of Auckland, Auckland, New Zealand 1023
Country 141030 0
New Zealand
Phone 141030 0
+64 21422119
Fax 141030 0
Email 141030 0
[email protected]
Contact person for public queries
Name 141031 0
Sue MacDonell
Address 141031 0
Department of Nutrition & Dietetics, University of Auckland, Auckland, New Zealand 1023
Country 141031 0
New Zealand
Phone 141031 0
+64 21422119
Fax 141031 0
Email 141031 0
[email protected]
Contact person for scientific queries
Name 141032 0
Sue MacDonell
Address 141032 0
Department of Nutrition & Dietetics, University of Auckland, Auckland, New Zealand 1023
Country 141032 0
New Zealand
Phone 141032 0
+64 21422119
Fax 141032 0
Email 141032 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: This is a feasibility study as a precursor to a larger trial



What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocol  [email protected]
Informed consent form    DF-FORM02 PIS and Consent ARC Residents v2b 250612 final.pdf


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.