Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001145594
Ethics application status
Approved
Date submitted
12/08/2024
Date registered
23/09/2024
Date last updated
23/09/2024
Date data sharing statement initially provided
23/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Is a high energy and protein ice cream dessert comparable to nutrition support beverages at managing malnutrition?
Scientific title
Measuring consumer’s change in weight and food satisfaction following switching from clinical dietary supplements to a food first approach in the form of a protein ice cream dessert to address malnutrition in aged care residents
Secondary ID [1] 312740 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
malnutrition 334774 0
Condition category
Condition code
Public Health 331331 331331 0 0
Health service research
Diet and Nutrition 331668 331668 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Food Imperative Frozen Dessert is an ice cream product that has been developed in collaboration with nutrition professionals to specially address the nutritional needs of aged care residents with malnutrition, inclusive of residents with dysphagia. The Food Imperative Frozen Dessert has been formulated with a unique blend of whey, caseinate and soy protein. Each 125ml serving provides 600kJ, 8g protein and 2.5g fibre, Additionally, the Food Imperative Frozen dessert is suitable for all levels of the International Dysphagia Diet Standardisation Initiative 2019 (IDSSI) 1,2 and 3.
Participants will spend a 2 week period of observation whilst receiving their usual care, immediately followed by a two week period of the intervention without any washout period in between. The frozen dessert will be provided twice daily at mid-meals for 14 days. Participants will consume the frozen dessert themselves or with assistance from staff where necessary. Adherence to the intervention will be monitored daily by staff, who will weigh the left overs to determine consumption.
Intervention code [1] 329262 0
Treatment: Other
Comparator / control treatment
The comparator is usual care provisions of 1-2 serves of a commercial oral nutritional supplement. Participants will spend a 2 week period of observation whilst receiving their usual care, followed by a two week period of the intervention. The oral supplement will vary depending on the site and the usual prescription for the resident.
Control group
Active

Outcomes
Primary outcome [1] 339090 0
Body weight
Timepoint [1] 339090 0
Day 14 (end of the observation period) and Day 28 (end of the intervention period)
Secondary outcome [1] 438519 0
Feasibility for aged care residents
Timepoint [1] 438519 0
day 14 (end of the observation period) and day 28 (end of the intervention period)
Secondary outcome [2] 438520 0
Feasibility for aged care staff
Timepoint [2] 438520 0
day 14 (end of observation period) and day 28 (end of intervention period)
Secondary outcome [3] 438521 0
Feasibility for Aged Care residents
Timepoint [3] 438521 0
Consumption of usual supplements will be assessed at day 14 (end of the observation period)
Consumption of the frozen dessert will be assessed at day 28 (end of the intervention period)

Eligibility
Key inclusion criteria
To be eligible, aged care residents must be receiving a minimum of 1 commercial nutritional supplement per day and be able to provide informed consent and information to be included in the study.

For the staff participants, workers must be either food service staff (involved in food preparation or delivery of food to residents) or carers (involved in the service of foods, commercial supplements and monitoring).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Aged Care Residents with food allergies or intolerances to soy, dairy, lactose, on an extremely thick fluid consistency, unable to provide consent or receiving palliative care will be excluded.

Aged Care Staff participants must be able to provide informed written consent and be able to read and write in English.

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
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/09/2024
Actual
Date of last participant enrolment
Anticipated
31/01/2025
Actual
Date of last data collection
Anticipated
28/02/2025
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 317171 0
Other Collaborative groups
Name [1] 317171 0
Aged Care Research and Industry Innovation Australia (ARIIA)
Country [1] 317171 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
MG Foods
Address
Country
Australia
Secondary sponsor category [1] 319436 0
University
Name [1] 319436 0
Aged Care Homes (ACH) Group
Address [1] 319436 0
Country [1] 319436 0
Australia
Other collaborator category [1] 283137 0
University
Name [1] 283137 0
Flinders University
Address [1] 283137 0
Country [1] 283137 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315916 0
Flinders University Human Research Ethics Committee
Ethics committee address [1] 315916 0
Ethics committee country [1] 315916 0
Australia
Date submitted for ethics approval [1] 315916 0
19/08/2024
Approval date [1] 315916 0
23/08/2024
Ethics approval number [1] 315916 0
7002

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

Contacts
Principal investigator
Name 136206 0
Mr Vitish Guddoy
Address 136206 0
MG Food Solutions 10 McLaren Street, Evanston Gardens South Australia 5116
Country 136206 0
Australia
Phone 136206 0
+61 0409035987
Fax 136206 0
Email 136206 0
[email protected]
Contact person for public queries
Name 136207 0
Jolene Thomas
Address 136207 0
College of Nursing and Health Sciences, Flinders University. GPO Box 2100 Adelaide South Australia 5001
Country 136207 0
Australia
Phone 136207 0
+61 0450522213
Fax 136207 0
Email 136207 0
[email protected]
Contact person for scientific queries
Name 136208 0
Jolene Thomas
Address 136208 0
College of Nursing and Health Sciences, Flinders University. GPO Box 2100 Adelaide South Australia 5001
Country 136208 0
Australia
Phone 136208 0
+61 0450522213
Fax 136208 0
Email 136208 0
[email protected]

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.