Trial Review

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
ACTRN12621000420842
Ethics application status
Approved
Date submitted
12/01/2021
Date registered
15/04/2021
Date last updated
7/04/2022
Date data sharing statement initially provided
15/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The Pomerium Trial: Effect of a Specialised Nutritional Supplementation on Immune Function in Older Adults Living in Residential Aged Care Facilities
Scientific title
The Pomerium Trial: A randomised controlled trial testing the effect of short-term (3 months) administration of a specialised nutritional supplement on the immune and musculoskeletal systems of older adults in aged-care
Secondary ID [1] 303152 0
Nil
Universal Trial Number (UTN)
Trial acronym
The Pomerium Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 320264 0
Malnutrition 320265 0
Condition category
Condition code
Infection 318195 318195 0 0
Other infectious diseases
Diet and Nutrition 318196 318196 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Specialised high-calorie oral nutritional supplement (Ensure Plus Strength marketed overseas as Ensure Plus Advance®) containing:
330 kcal (1.5 kcal/ml), 20 g of protein, 13 µg of vitamin D (500 IU), 499 mg of calcium and 1.5g of CaHMB (calcium-ß-hydroxy-ß-methylbutyrate), and multiple minerals and micronutrients.

The supplement (220 ml bottle) will be administered by the local nurse/nurse technician twice a day for 3 months to the intervention group.
Intervention code [1] 319458 0
Treatment: Other
Comparator / control treatment
Usual care refers to the regular diet provided at each participating RACF. This trial will compare the effect of a specialised multi-nutrient drink on immune
function in older adults in residing in RACFs compared to usual care (adjunct to standard treatment).
Control group
Active

Outcomes
Primary outcome [1] 326178 0
Composite primary outcome: between group difference in T-cell subsets CD8+ and CD28null assessed by flow cytometry.
Timepoint [1] 326178 0
Baseline, 1 and 3 months post-randomisation.
Secondary outcome [1] 390390 0
Composite secondary outcome: Between group differences in incidence and severity of COVID-19 and/or respiratory viral infections and their associated complications (i.e. hospitalisations, complications, and mortality, assessed by inspection of medical records.
Timepoint [1] 390390 0
3 months and 6 months post-randomisation
Secondary outcome [2] 390391 0
Between groups differences in handgrip strength assessed by dynamometer.
Timepoint [2] 390391 0
Baseline and 3 months post-randomisation
Secondary outcome [3] 390392 0
Between groups differences in cytokines serum levels, including but not limited to IL-3, IL-5, etc., quantified by ELISA.
Timepoint [3] 390392 0
Baseline, 1 month and 3 months post-randomisation
Secondary outcome [4] 390393 0
Between the group difference in respiratory function assessed by spirometry.
Timepoint [4] 390393 0
Baseline and 3 months post-randomisation
Secondary outcome [5] 392826 0
Between groups differences in gait velocity measured using a stopwatch.
Timepoint [5] 392826 0
Baseline and 3 months post-randomisation
Secondary outcome [6] 392827 0
Between groups change in appendicular lean mass (ALM) measured by bioelectrical impedance.
Timepoint [6] 392827 0
Baseline and 3 months post-randomisation
Secondary outcome [7] 392828 0
Between groups change in short Physical Performance Battery (SPPB) score.
Timepoint [7] 392828 0
Baseline and 3 months post-randomisation
Secondary outcome [8] 392829 0
Between group changes in serum Hb
Timepoint [8] 392829 0
Baseline, 1 month and 3 months post-randomisation
Secondary outcome [9] 393228 0
Between group changes in serum albumin
Timepoint [9] 393228 0
Baseline, 1 month and 3 months post-randomisation
Secondary outcome [10] 393229 0
Between group changes in serum vitamin D.
Timepoint [10] 393229 0
Baseline, 1 month and 3 months post-randomisation
Secondary outcome [11] 393607 0
Dietary intake assessed visually by the plate waste method.
Timepoint [11] 393607 0
Baseline and 3 months post-randomisation
Secondary outcome [12] 408477 0
Patient-reported Quality of Life (QoL) EQ-5D
Timepoint [12] 408477 0
Baseline and 3 months post-randomisation

Eligibility
Key inclusion criteria
• Men and women aged 75 years or older living at a residential aged care facility (RACF);
• Sarcopenia diagnosed using Sarcopenia Definition and Outcomes Consortium (SDOC) criteria;
• Subjects must weigh at least 40.0 kg to participate in the study and have a body mass index (BMI) within the range of 18.0 – 30.0 kg/m2;
Minimum age
75 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Less than 2 points in the Eating Validation Scheme (EVS);
• Bedbound residents;
• Not able or willing to give informed consent.
• Participants on immunomodulators or corticosteroid medications

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The randomisation sequence will be prepared by AI Sara Vogrin (Biostatistician) using computer-generated randomisation. Once randomisation has occurred, the assessors and participants will be blinded to group allocation. The CIs and their teams will collect all baseline measurements of primary and secondary outcomes prior to randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be individual randomisation (permuted block) stratified by the nursing home to average any effect of nursing home factors (diet, care, resident characteristics). The randomisation sequence will be generated by the trial statistician Dr Sara Vogrin) via Redcap on site after the initial assessments.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering 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
All the results will be reported according to CONSORT guidelines for reporting randomised clinical trials. Descriptive statistics will be used to summarise information collected for each outcome on each time-point. The primary outcome of the study is comparison of T-cell subsets CD8+ and CD28null 3 months post randomisation which will be assessed using ANCOVA with adjustment for baseline levels. If the model is of poor fit by visual inspection of residuals, outcome will be transformed using natural logarithm. If the model fit will be still insufficient, rank-sum test will be used for analysis.

Analysis will be on intention to treat basis with additional analysis of per-protocol. The extent of missing data will be evaluated and if minimal (i.e., baseline and 1-month visits), complete case analysis will be performed. Otherwise complete case analysis with adjustment for prognostic baseline covariates will be used as it has been shown that it does not underperform compared to more sophisticated multiple imputation.

All other secondary outcomes will follow the same statistical analysis using linear regression for continuous outcomes and negative binomial regression for counts. Statistical significance will be assumed at p<0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/04/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 307557 0
Government body
Name [1] 307557 0
National Health and Medical Research Council (NHMRC)/Medical Research Future Fund
Country [1] 307557 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Parkville VIC 3010
Country
Australia
Secondary sponsor category [1] 308245 0
None
Name [1] 308245 0
Address [1] 308245 0
Country [1] 308245 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307619 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 307619 0
300 Grattan St, Parkville VIC 3050
Ethics committee country [1] 307619 0
Australia
Date submitted for ethics approval [1] 307619 0
31/03/2021
Approval date [1] 307619 0
15/07/2021
Ethics approval number [1] 307619 0
HREC/73985/MH-2021

Summary
Brief summary
Ageing is associated with a progressive deterioration of the immune system function, described as immunosenescence, which contributes to an increased risk of morbidity, poor responses to vaccination, and increased mortality in older persons.

The COVID-19 pandemic has disproportionately impacted older people; particularly those living at residential aged care facilities (RACFs). In Australia, the death toll in RACFs has been devastating with two thirds of the current deaths in Victoria happening in residents of RACFs.

Considering that calcium ß-Hydroxy-ß-Methylbutyrate (CaHMB), vitamin D, and protein supplementation have demonstrated a beneficial effect not only on the immune system but also on muscle mass and strength and respiratory function in frail older persons, we propose a cluster, randomised, placebo controlled trial administering residents in Victorian RACFs (n= 160) a multinutrient supplement versus usual care for 3 months. Overall, their immune response and improvement in muscle mass and strength, and respiratory function will be documented.

Our results will fulfil an unmet need in this very high-risk population by testing whether a specialised nutritional supplement administered within a short period of time could prepare RACFs against this and potential future pandemics while preventing complications and adverse outcomes, and enhancing their immune response to current vaccines.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 107886 0
Prof Gustavo Duque
Address 107886 0
Australian Institute for Musculoskeletal Science (AIMSS)
Level 3 WCHRE
176 Furlong Road
St Albans, VIC 3021
Country 107886 0
Australia
Phone 107886 0
+61 3 8395 8121
Fax 107886 0
Email 107886 0
[email protected]
Contact person for public queries
Name 107887 0
Mrs Petra Marusic
Address 107887 0
Australian Institute for Musculoskeletal Science (AIMSS)
Level 3 WCHRE
176 Furlong Road
St Albans, VIC 3021
Country 107887 0
Australia
Phone 107887 0
+61 3 8395 8258
Fax 107887 0
Email 107887 0
[email protected]
Contact person for scientific queries
Name 107888 0
Prof Gustavo Duque
Address 107888 0
Australian Institute for Musculoskeletal Science (AIMSS)
Level 3 WCHRE
176 Furlong Road
St Albans, VIC 3021
Country 107888 0
Australia
Phone 107888 0
+61 3 8395 8121
Fax 107888 0
Email 107888 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data that support any results reported in a published article after de-identification.
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following article publication.
Available to whom?
Data will be available for researchers when the use of this de-identifiable data has been approved by a reviewing committee of investigators and an independent ethics committee.


Available for what types of analyses?
Data analysis
How or where can data be obtained?
Data can be obtained from primary investigator (PI) via email: [email protected]
or Via AIMSS generic email and clinical trials officer (Petra Marusic: [email protected])


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
SourceTitleYear of PublicationDOI
EmbaseEffects of 3 months of multi-nutrient supplementation on the immune system and muscle and respiratory function of older adults in aged care (The Pomerium Study): protocol for a randomised controlled trial.2022https://dx.doi.org/10.1136/bmjopen-2021-059075
N.B. These documents automatically identified may not have been verified by the study sponsor.