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Trial registered on ANZCTR


Registration number
ACTRN12621001076864p
Ethics application status
Submitted, not yet approved
Date submitted
29/06/2021
Date registered
16/08/2021
Date last updated
16/08/2021
Date data sharing statement initially provided
16/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the intake of nutritional beverages in hospitalised older adults
Scientific title
A randomised single-blinded intervention study investigating the intake of nutritional beverages in hospitalised older adults
Secondary ID [1] 304616 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malnutrition 322534 0
At risk of malnutrition 322939 0
Condition category
Condition code
Diet and Nutrition 320163 320163 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study aims to assess the intake of nutritional beverages in hospitalised older adults, and to determine what effects the beverages have on the older adults.

WHAT:
Participants identified as requiring a nutritional supplement during their time in hospital will be given one of two different beverages. The intervention beverage has a proprietary formulation which has been formulated to increase palatability and gastric comfort.
WHO PROVIDED:
The intervention will be conducted by research dieticians/research nurses/research assistants and will be overseen by a University researcher.
HOW & WHERE:
The intervention will take place in a hospital, and patients will be recruited form the acute admissions wards. The research dietician will collect the data whilst the participants are in hospital.
WHEN & HOW MUCH:
Participants will be given two serves per day. The beverages will be supplied to the participants for up to 28 days during their hospital stay, or until they request to stop taking them, or until they are no longer at risk of malnutrition. The amount of beverage consumed per occasion will be determined, and documented, by the research dietician/research nurse.

Intervention code [1] 320976 0
Treatment: Other
Comparator / control treatment
The control group will be given a standard nutritional beverage,
Control group
Active

Outcomes
Primary outcome [1] 328060 0
Compliance will be measured through weighing the amount of the beverage pre- and post-consumption, using a set of digital scales, and calculating the difference. This will be done by the research dietician/research nurse two hours after the participants are given their beverages.
Timepoint [1] 328060 0
Compliance will be measured for the duration of the intervention.
Secondary outcome [1] 397384 0
Weight will be recorded at baseline by the ward nurse or clinical dietician. The scales used will depend on the mobility of the participant (sitting or standing scales). The same scales will be used by the research dietician/nurse or the clinical dietician for each of the follow-up measurements.
Timepoint [1] 397384 0
Weight will be measured at baseline and on a weekly basis for the duration on the intervention and at the end of the intervention. Baseline weight measurements will be made by the ward nurse or clinical dietician and the follow-up weight measurements will be made by either the clinical dietician or the research dietician/research nurse.

Eligibility
Key inclusion criteria
Hospitalised
Identified as malnourished or at risk of malnutrition
Prescribed nutritional supplements
Able to provide informed consent or consent obtainable from their EPOA for health and welfare
>65 years of age
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
<65 years
Cannot provide informed consent or do not have an EPOA for health and welfare who can provide informed consent
Renal status would contraindicate the consumption of the supplement
Have a planned discharge within 48 hours of starting the supplementation
Have a terminal illness requiring palliative care
Have a dairy of soy allergy
Require Halal or Kosher diets
Require nasogastric or parental feeding
Are taking dietary supplements which could influence the outcome of the study
Have a clinical condition that, in the investigator’s judgement, could interfere with the intestinal barrier function

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size calculations are based on previous research findings investigating compliance levels with similar nutrition supplements in a similar population group.

Continuous baseline data will be presented as mean and standard deviation (normally distributed) or median and inter-quartile range (non-normal distribution)

Categorical data will be grouped appropriately and presented as count and percentage.

Main analysis will focus on change from baseline to end of intervention. Analysis of Covariance model will include a minimum of treatment group and treatment duration but may include additional confounding factors as required.

Secondary analyses for parameters measured on multiple occasions will include repeated measure Analysis of Variance.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 23921 0
New Zealand
State/province [1] 23921 0
Auckland

Funding & Sponsors
Funding source category [1] 308976 0
Commercial sector/Industry
Name [1] 308976 0
Fonterra Research and Development Centre
Address [1] 308976 0
Fonterra Co-operative Group Limited
Private Bag 11029
Palmerston North 4442
Country [1] 308976 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fonterra Research and Development Centre
Address
Fonterra Co-operative Group Limited
Private Bag 11029
Palmerston North 4442
Country
New Zealand
Secondary sponsor category [1] 309910 0
None
Name [1] 309910 0
Address [1] 309910 0
Country [1] 309910 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 308868 0
Health and Disability Ethics Committee
Ethics committee address [1] 308868 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 308868 0
New Zealand
Date submitted for ethics approval [1] 308868 0
08/07/2021
Approval date [1] 308868 0
Ethics approval number [1] 308868 0

Summary
Brief summary
The study aims to determine whether a proprietary nutritional supplement is more effective than a standard supplement in meeting the nutritional needs of elderly hospitalised patients. The hypothesis states that greater improvements in compliance, and subsequently nutrition status, will be seen in those participants who are given the proprietary supplement.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112162 0
Dr Andrea Braakhuis
Address 112162 0
Academic Director
Nutrition and Dietetics
Faculty of Medical and Health Sciences
University of Auckland
85 Park Road
Grafton
Auckland 1023
Country 112162 0
New Zealand
Phone 112162 0
+64 9 923 6251
Fax 112162 0
Email 112162 0
a.braakhuis@auckland.ac.nz
Contact person for public queries
Name 112163 0
Dr Andrea Braakhuis
Address 112163 0
Academic Director
Nutrition and Dietetics
Faculty of Medical and Health Sciences
University of Auckland
85 Park Road
Grafton
Auckland 1023
Country 112163 0
New Zealand
Phone 112163 0
+64 9 923 6251
Fax 112163 0
Email 112163 0
a.braakhuis@auckland.ac.nz
Contact person for scientific queries
Name 112164 0
Dr Karen Munday
Address 112164 0
Fonterra Co-operative Group Limited
Private Bag 11029
Palmerston North 4442
Country 112164 0
New Zealand
Phone 112164 0
+64 6 350 6567
Fax 112164 0
Email 112164 0
karen.munday2@fonterra.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Release of clinical trial data may compromise future patents and other intellectual property assets
What supporting documents are/will be available?
No other documents available
Summary results
No Results