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The 4F study - fibre-fortified foods & fluids for Aged Residential Care (ARC) in Aotearoa New Zealand

The Feasibility of Fibre-Fortified Foods & Fluids in Aged Residential Care (ARC) in Aotearoa New Zealand (4F)

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000655448
Acronym
4F
Enrollment
40
Registered
2025-06-20
Start date
2025-06-23
Completion date
2025-12-19
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study will trial a tasteless, commercially available fibre supplement that will be given to people living in Aged Residential Care (ARC).The dietary fibre intake of aged care residents is known to be low. The supplement (PrebiolaxTM) will be mixed into foods and beverages to help improve their fibre intake. It can be mixed into drinks and moist foods like soups and yoghurt, and does not change the taste or consistency of the food and drink. Changes in bowel function and comfort will be assessed over 6 weeks, and we will also investigate how acceptable the fibre supplement is and how feasible it is to use in aged care facilities. The results of this study will help guide future interventions to increase fibre intake and reduce laxative use among the elderly population in Aotearoa's aged care facilities.

Interventions

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

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

Sponsors

McLeod Nutrition
Lead SponsorCommercial sector/Industry

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
65 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

• Residents of aged residential care facilities in NZ. • Able to provide informed consent

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).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026