Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000842763
Ethics application status
Approved
Date submitted
25/05/2022
Date registered
15/06/2022
Date last updated
15/10/2023
Date data sharing statement initially provided
15/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the intake of nutritional beverages in older adults living in residential care facilities.
Scientific title
A randomised single-blinded intervention study investigating the intake of nutritional beverages in older adults in residential care.
Secondary ID [1] 307193 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malnourished 326417 0
At risk of malnutrition 326418 0
Condition category
Condition code
Diet and Nutrition 323701 323701 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
WHY
Background and aims
This study aims to assess the compliance to novel nutritional supplements in older adults living in residential care with malnutrition or at risk of malnutrition. It aims to determine if the supplements have a higher level of compliance when compared to the standard product.

Participants
Adults over the age of 65 living in residential care who are at risk of malnutrition or who are malnourished.

WHAT
Participants identified as requiring a nutritional supplement will be given either the standard supplement (control group) or a new preparatory supplement which has been formulated to increase palatability and gastric comfort (intervention group).

WHO PROVIDED
The intervention will be conducted by the residential home staff and will be overseen by clinical researchers.

HOW & WHERE
Participants will be recruited from residential care homes where the intervention will take place. The residential care home staff will collect data whilst the participants are undergoing the intervention, under the guidance of the clinical researchers.

WHEN & HOW MUCH
Participants will be given two serves per day for seven days. The supplements (either the proprietary supplements or standard supplement) will be taken orally. The supplements will be supplied to the participants for the duration of the intervention.
Compliance will be assessed after each supplementation occasion through measuring the amount of the supplement consumed. Dietary information will be recorded and some health-related data will be collected.

The participants will be provided with the comparator or proprietary beverage for seven days, and will cross-over at the end of the seven day period. As the study group require these nutritional supplements, there will be no washout period.
Intervention code [1] 323653 0
Treatment: Other
Comparator / control treatment
The comparator will be a commercially available standard nutritional beverage supplement (12g protein/serve and 2.4kcal/ml).
Control group
Active

Outcomes
Primary outcome [1] 331468 0
Compliance to nutritional beverage as assessed by 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 researcher. The participants will be given up to two hours to consume their beverage.
Timepoint [1] 331468 0
Twice daily for seven days after the start of the intervention
Secondary outcome [1] 410007 0
Tolerance - documentation of gastric-related adverse events via a tick box questionnaire filled out by the nursing/care staff,.
Timepoint [1] 410007 0
Daily throughout the intervention period
Secondary outcome [2] 410146 0
Palatability - assessed through a standardised questionnaire designed and used previously by the sponsor.
Timepoint [2] 410146 0
Bi-weekly throughout the intervention period
Secondary outcome [3] 410149 0
Satiety - assessed through a standardised questionnaire designed and used previously by the sponsor.
Timepoint [3] 410149 0
Bi-weekly throughout intervention period

Eligibility
Key inclusion criteria
>65 year
Male and female
Identified as malnourished or at risk of malnutrition
Prescribed nutritional supplements
Able to provide informed consent
Living in a residential care facility
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
<65 years
Cannot provide informed consent
Renal status would contraindicate the consumption of the supplement
Have a terminal illness requiring palliative care
Have a dairy or soy allergy
Require Halal or Kosher diets
Require nasogastric or parental feeding
Recent hospitalisation
Are taking dietary supplements which could influence the outcome of the study
Have a clinical condition that, in the investigator’s judgement, is contraindicated

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)
Simple randomisation through computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculations have been based on previous research findings investigating compliance levels with similar nutrition supplements in a similar population group.

Statistical methods/analysis
The method of analysis will include descriptive and inferential statistics. All analysis requiring significance testing will be two-sided at a 5% level of significance. Inferential results will be supported with the strength of result (effect size).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/08/2022
Actual
8/11/2022
Date of last participant enrolment
Anticipated
25/11/2022
Actual
31/07/2023
Date of last data collection
Anticipated
16/12/2022
Actual
18/08/2023
Sample size
Target
100
Accrual to date
Final
100
Recruitment outside Australia
Country [1] 24793 0
Ireland
State/province [1] 24793 0

Funding & Sponsors
Funding source category [1] 311498 0
Commercial sector/Industry
Name [1] 311498 0
Fonterra Research and Development Centre
Country [1] 311498 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] 312898 0
None
Name [1] 312898 0
Address [1] 312898 0
Country [1] 312898 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310958 0
Clinical Research Ethics Committee of the Cork Teaching Hospitals
Ethics committee address [1] 310958 0
Ethics committee country [1] 310958 0
Ireland
Date submitted for ethics approval [1] 310958 0
07/06/2022
Approval date [1] 310958 0
03/10/2022
Ethics approval number [1] 310958 0

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

Contacts
Principal investigator
Name 119498 0
Prof D William Molloy
Address 119498 0
C/O Atlantia Food Clinical Trials,
1st Floor,
Block C,
Heron House,
Blackpool Retail Park,
Cork
T23 R50R
Country 119498 0
Ireland
Phone 119498 0
+353 021 430 7442
Fax 119498 0
Email 119498 0
[email protected]
Contact person for public queries
Name 119499 0
Karen Munday
Address 119499 0
Fonterra Co-operative Group Limited
Private Bag 11029
Palmerston North 4442
Country 119499 0
New Zealand
Phone 119499 0
+64 06 3506567
Fax 119499 0
Email 119499 0
[email protected]
Contact person for scientific queries
Name 119500 0
Karen Munday
Address 119500 0
Fonterra Co-operative Group Limited
Private Bag 11029
Palmerston North 4442
Country 119500 0
New Zealand
Phone 119500 0
+64 06 3506567
Fax 119500 0
Email 119500 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.