ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

The Pomerium Trial

Linked study record

Health condition

Health condition(s) or problem(s) studied:

COVID-19

Malnutrition

Condition category

Condition code

Infection

Other infectious diseases

Diet and Nutrition

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]

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]

Composite primary outcome: between group difference in T-cell subsets CD8+ and CD28null assessed by flow cytometry.

Timepoint [1]

Baseline, 1 and 3 months post-randomisation.

Secondary outcome [1]

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]

3 months and 6 months post-randomisation

Secondary outcome [2]

Between groups differences in handgrip strength assessed by dynamometer.

Timepoint [2]

Baseline and 3 months post-randomisation

Secondary outcome [3]

Between groups differences in cytokines serum levels, including but not limited to IL-3, IL-5, etc., quantified by ELISA.

Timepoint [3]

Baseline, 1 month and 3 months post-randomisation

Secondary outcome [4]

Between the group difference in respiratory function assessed by spirometry.

Timepoint [4]

Baseline and 3 months post-randomisation

Secondary outcome [5]

Between groups differences in gait velocity measured using a stopwatch.

Timepoint [5]

Baseline and 3 months post-randomisation

Secondary outcome [6]

Between groups change in appendicular lean mass (ALM) measured by bioelectrical impedance.

Timepoint [6]

Baseline and 3 months post-randomisation

Secondary outcome [7]

Between groups change in short Physical Performance Battery (SPPB) score.

Timepoint [7]

Baseline and 3 months post-randomisation

Secondary outcome [8]

Between group changes in serum Hb

Timepoint [8]

Baseline, 1 month and 3 months post-randomisation

Secondary outcome [9]

Between group changes in serum albumin

Timepoint [9]

Baseline, 1 month and 3 months post-randomisation

Secondary outcome [10]

Between group changes in serum vitamin D.

Timepoint [10]

Baseline, 1 month and 3 months post-randomisation

Secondary outcome [11]

Dietary intake assessed visually by the plate waste method.

Timepoint [11]

Baseline and 3 months post-randomisation

Secondary outcome [12]

Patient-reported Quality of Life (QoL) EQ-5D

Timepoint [12]

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?

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]

Government body

Name [1]

National Health and Medical Research Council (NHMRC)/Medical Research Future Fund

Address [1]

Department of Health
GPO Box 9848
Canberra ACT 2601
Australia

Country [1]

Australia

Primary sponsor type

University

Name

University of Melbourne

Address

Parkville VIC 3010

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Melbourne Health Human Research Ethics Committee

Ethics committee address [1]

300 Grattan St, Parkville VIC 3050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

31/03/2021

Approval date [1]

15/07/2021

Ethics approval number [1]

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

Prof Gustavo Duque

Address

Australian Institute for Musculoskeletal Science (AIMSS)
Level 3 WCHRE
176 Furlong Road
St Albans, VIC 3021

Country

Australia

Phone

+61 3 8395 8121

Fax

gustavo.duque@unimelb.edu.au

Contact person for public queries

Name

Petra Marusic

Address

Australian Institute for Musculoskeletal Science (AIMSS)
Level 3 WCHRE
176 Furlong Road
St Albans, VIC 3021

Country

Australia

Phone

+61 3 8395 8258

Fax

petra.marusic@unimelb.edu.au

Contact person for scientific queries

Name

Gustavo Duque

Address

Australian Institute for Musculoskeletal Science (AIMSS)
Level 3 WCHRE
176 Furlong Road
St Albans, VIC 3021

Country

Australia

Phone

+61 3 8395 8121

Fax

gustavo.duque@unimelb.edu.au

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: Gustavo.duque@unimelb.edu.au
or Via AIMSS generic email and clinical trials officer (Petra Marusic: petra.marusic@unimelb.edu.au)

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

Source	Title	Year of Publication	DOI
Embase	Effects 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.	2022	https://dx.doi.org/10.1136/bmjopen-2021-059075

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added automatically