Skip to content

The Pomerium Trial: Effect of a Specialised Nutritional Supplementation on Immune Function in Older Adults Living in Residential Aged Care Facilities

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000420842
Acronym
The Pomerium Trial
Enrollment
40
Registered
2021-04-15
Start date
2023-05-01
Completion date
Unknown
Last updated
2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Sponsors

University of Melbourne
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
75 Years to No maximum
Healthy volunteers
No

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;

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

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 14, 2026