Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001076864
Ethics application status
Approved
Date submitted
29/06/2021
Date registered
16/08/2021
Date last updated
27/10/2023
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 adults undergoing lower GI surgery.

WHAT:
Participants identified undergoing lower GI surgery will be invited to participate in the stufy. They will be offere the intervention beverage or follow standard treatment. 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 lower GI surgical 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 30 days, 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 care, which follows the enhanced recovery after surgery protocol. This change was made prior to recruitment commencing.
Control group
Active

Outcomes
Primary outcome [1] 336415 0
Muscle mass using US
Timepoint [1] 336415 0
Primary outcome [2] 336416 0
Muscle mass using US
Timepoint [2] 336416 0
Muscle mass will be assessed at baseline, 1 day post-operatively, and at the end of the intervention
Secondary outcome [1] 428255 0
Grip strength using a dynamometer
Timepoint [1] 428255 0
Secondary outcome [2] 428256 0
Grip strength using a dynamometer
Timepoint [2] 428256 0
Grip strength will be assesed at baseline, 1 day post-operatively and at the end of the intervention
Secondary outcome [3] 428257 0
Compliance wil be measured through measuring the amount of beverage pre-and port-consumption. This will be done either by the participant or by one of the research team.
Timepoint [3] 428257 0
Grip strength will be assesed at baseline, 1 day post-operatively and at the end of the intervention
Secondary outcome [4] 428258 0
Compliance wil be measured through measuring the amount of beverage pre-and port-consumption. This will be done either by the participant or by one of the research team.
Timepoint [4] 428258 0
This will be done daily throughout the intervention
Secondary outcome [5] 428259 0
Nutritional status through 24-hour diet recall
Timepoint [5] 428259 0
This will be done daily throughout the intervention
Secondary outcome [6] 428260 0
Nutritional status through 24-hour diet recall
Timepoint [6] 428260 0
Nutrtional status will be measured at baseline and weekly througout the intervention and at the end of the intervention

Eligibility
Key inclusion criteria
Hospitalised
Undergoing lower GI surgery
Able to provide informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cannot 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
13/11/2023
Actual
Date of last participant enrolment
Anticipated
27/09/2024
Actual
Date of last data collection
Anticipated
15/11/2024
Actual
Sample size
Target
60
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
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
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
18/09/2023
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
[email protected]
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
[email protected]
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
[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
Release of clinical trial data may compromise future patents and other intellectual property assets


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.