Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12622000888763
Ethics application status
Approved
Date submitted
11/06/2022
Date registered
22/06/2022
Date last updated
22/06/2022
Date data sharing statement initially provided
22/06/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Hydrolysed meat in residential aged-care trial
Scientific title
Investigating the nutritional and health outcomes of hydrolysed meat meals for aged-care residents with dysphagia
Secondary ID [1] 307333 0
None
Universal Trial Number (UTN)
U1111-1260-6088
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dysphagia 326618 0
Malnutrition 326619 0
Condition category
Condition code
Diet and Nutrition 323871 323871 0 0
Other diet and nutrition disorders
Oral and Gastrointestinal 323899 323899 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single-blinded cross-over design will be carried out, with 6-week intervention/control, 2-week washout and 6- weekcontrol/intervention. Participants will be randomised by block and assigned as Group A and Group B to receive either intervention (hydrolysed meat) or control (cook-fresh pureed meat) in the first 6 weeks. During the 2 weeks of washout period, participants will not receive any treatment and continue on their usual pureed diet provided by their aged care facilities. After the washout period, they will receive the alternative treatment in the last 6 weeks.
Hydrolysed meat contains higher energy (1010kJ/100g vs 638kJ/100g) and protein (20.8g/100g vs 14g/100g) compared to freshly made meat purees.
During the intervention, hydrolysed meat will be given at lunch and dinner when they usually have meat meals.
During the control and intervention period, a 24-hour dietary record will be collected on two non-consecutive days each week using a plate wastage visual estimation method.
During the washout period, participants will receive no treatment and therefore, they will continue having their usual diet, which is freshly made pureed meals from the foodservice.
Foodservice staff will be trained by the research dietitian to prepare, heat up and store the hydrolysed meat. During the intervention period, chefs will continue to prepare pureed diets using their regular recipes but replaced the usual raw meat with hydrolysed meat. The presentation of hydrolysed meat and freshly made pureed meat have no significant differences. Nurses and caregivers are blinded to the treatment, they will collect the plated pureed meals from kitchen and serve to residents as usual.
Intervention code [1] 323770 0
Treatment: Other
Comparator / control treatment
Traditional freshly-made pureed meals by aged care foodservice based on their own menu.
Control group
Active

Outcomes
Primary outcome [1] 331677 0
Nutrition intake will be assessed on two non-consecutive days throughout the control and intervention period. A 24-hr dietary record will be collected using a plate wastage visual estimation method.
Timepoint [1] 331677 0
Baseline, end of each treatment period (6 weeks and 14 weeks post-randomisation)
Primary outcome [2] 331678 0
Nutritional status determined using body weight assessed by digital chair scale before breakfast in the morning at each data collection point.
Timepoint [2] 331678 0
Baseline, end of each period (6 weeks, 8weeks and 14 weeks post-randomisation)
Secondary outcome [1] 410761 0
Nutritional assessment using malnutrition screening by Mini-Nutritional Assessment Short Form
Timepoint [1] 410761 0
Baseline, end of each period (6 weeks, 8weeks and 14 weeks post-randomisation)
Secondary outcome [2] 410841 0
Handgrip strength assessed by dynamometer
Timepoint [2] 410841 0
Baseline, end of each period (6 weeks, 8weeks and 14 weeks post-randomisation)
Secondary outcome [3] 410842 0
Amino acids via fasting blood samples taken by a phlebotomist.
Timepoint [3] 410842 0
Baseline, end of each period (6 weeks, 8 weeks and 14 weeks post-randomisation)
Secondary outcome [4] 410843 0
Body composition will be measured by a single frequency Bioelectrical Impedance Analysis (BIA)
Timepoint [4] 410843 0
Baseline, end of each period (6 weeks, 8 weeks and 14 weeks post-randomisation)
Secondary outcome [5] 410844 0
Nutritional status determined using calf circumference assessed by a dedicated tape measure,
Timepoint [5] 410844 0
Baseline, end of each period (6 weeks, 8 weeks and 14 weeks post-randomisation)
Secondary outcome [6] 410964 0
C-reactive protein via fasting blood samples taken by a phlebotomist.
Timepoint [6] 410964 0
Baseline, end of each period (6 weeks, 8 weeks and 14 weeks post-randomisation)
Secondary outcome [7] 410965 0
Albumni via fasting blood samples taken by a phlebotomist.
Timepoint [7] 410965 0
Baseline, end of each period (6 weeks, 8 weeks and 14 weeks post-randomisation)
Secondary outcome [8] 410966 0
IGF-1 via fasting blood samples taken by a phlebotomist.
Timepoint [8] 410966 0
Baseline, end of each period (6 weeks, 8 weeks and 14 weeks post-randomisation)
Secondary outcome [9] 410967 0
Nutritional status determined using mid-upper arm circumference assessed by a dedicated tape measure,
Timepoint [9] 410967 0
Baseline, end of each period (6 weeks, 8 weeks and 14 weeks post-randomisation)

Eligibility
Key inclusion criteria
Residents aged 65yr and over living in aged-care facilities, are prescribed with pureed diet by speech-language therapists and consuming pureed diet daily
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Respite or palliative care, <65yr, only have a partially pureed diet, unable to consume beef/chicken, receiving enteral or parenteral feeds.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using procedures like coin-tossing.
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
Completed
Date of first participant enrolment
Anticipated
Actual
12/05/2021
Date of last participant enrolment
Anticipated
Actual
22/05/2021
Date of last data collection
Anticipated
Actual
24/09/2021
Sample size
Target
26
Accrual to date
Final
22
Recruitment outside Australia
Country [1] 24834 0
New Zealand
State/province [1] 24834 0
Auckland

Funding & Sponsors
Funding source category [1] 311625 0
Other Collaborative groups
Name [1] 311625 0
Callaghan Innovation
Country [1] 311625 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
85 Park Rd, Grafton, Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 313062 0
None
Name [1] 313062 0
Address [1] 313062 0
Country [1] 313062 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311081 0
Northern A Health and Disability Ethics Committees
Ethics committee address [1] 311081 0
Ethics committee country [1] 311081 0
New Zealand
Date submitted for ethics approval [1] 311081 0
Approval date [1] 311081 0
11/05/2021
Ethics approval number [1] 311081 0
21/NTA/33

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

Contacts
Principal investigator
Name 119874 0
Dr Andrea Braakhuis
Address 119874 0
The University of Auckland. Office 201, M&HS BUILDING 504, 85 Park Rd, Grafton, Auckland 1023
Country 119874 0
New Zealand
Phone 119874 0
+64 909236251
Fax 119874 0
Email 119874 0
[email protected]
Contact person for public queries
Name 119875 0
Xiaojing Sharon Wu
Address 119875 0
The University of Auckland, Office 234, M&HS BUILDING 504, 85 Park Rd, Grafton 1023
Country 119875 0
New Zealand
Phone 119875 0
+64 2108599592
Fax 119875 0
Email 119875 0
[email protected]
Contact person for scientific queries
Name 119876 0
Xiaojing Sharon Wu
Address 119876 0
The University of Auckland, Office 234, M&HS BUILDING 504, 85 Park Rd, Grafton 1023
Country 119876 0
New Zealand
Phone 119876 0
+64 2108599592
Fax 119876 0
Email 119876 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Only researchers who provide a methodologically sound proposal

Conditions for requesting access:
• -

What individual participant data might be shared?
• Individual participant data underlying published results only

What types of analyses could be done with individual participant data?
• Only to achieve the aims in the approved proposal

When can requests for individual participant data be made (start and end dates)?
From:
Beginning 3 months and ending 5 years following main results publication

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Access subject to approvals by Principal Investigator ([email protected])

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16362Ethical approval  [email protected]
16415Clinical study report  [email protected]



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.