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

  1. Ahmed Al Saedi
  2. Ben Kirk
  3. Sandra Iuliano
  4. Jesse Zanker
  5. Sara Vogrin
  6. Lata Jayaram
  7. Shane Thomas
  8. Christine Golding
  9. Diana Navarro-Perez
  10. Petra Marusic
  11. Sean Leng
  12. Ralph Nanan
  13. Gustavo Duque

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Abstract

Immunosenescence leads to increased morbidity and mortality associated with viral infections and weaker vaccine responses. This has been well documented for seasonal influenza and the current pandemic with SARS-CoV-2 (COVID-19), which disproportionately impact older adults, particularly those in residential aged care facilities. Inadequate nutrient intakes associated with impaired immunity, respiratory and muscle function are likely to augment the effects of immunosenescence. In this study, we test whether the impact of inadequate nutrition can be reversed using multi-nutrient supplementation, consequently enhancing vaccine responses, reducing the risk of viral infections and improving respiratory and muscle function.

Methods and analysis

The Pomerium Study is a 3-month, single-blind, randomised, controlled trial testing the effects of two daily servings of an oral multi-nutrient supplement (330 kcal, 20 g protein, 1.5 g calcium 3-hydroxy-3-methylbutyrate monohydrate (CaHMB), 449 mg calcium, 500 IU vitamin D 3 and 25 vitamins and minerals) on the immune system and muscle and respiratory function of older adults in aged care in Melbourne, Australia. 160 older adults (≥75 years old) will be recruited from aged care facilities and randomised to treatment (multi-nutrient supplement) or control (usual care). The primary outcome is a change in T-cell subsets CD8 + and CD28null counts at months 1 and 3. Secondary outcomes measured at baseline and month 3 are multiple markers of immunosenescence (also at 1 month), body composition (bioimpedance), handgrip strength (dynamometer), physical function (short physical performance battery), respiratory function (spirometry) and quality of life (EQ-5D-5L). Incidence and complications of COVID-19 and/or viral infections (ie, hospitalisation, complications or death) will be recorded throughout the trial, including 3 months after supplementation is ceased.

Ethics and dissemination

This study was approved by Melbourne Health Human Research Ethics Committee (Ref No. HREC/73985/MH-2021, ERM Ref No. RMH73985, Melbourne Health Site Ref No. 2021.115). Written informed consent will be obtained from participants. Results will be published in peer-reviewed journals and made available to key aged care stakeholders, including providers, residents, and government bodies.

Trial registration number

ACTRN12621000420842.

Article activity feed

  1. Version published to 10.1136/bmjopen-2021-059075
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    SciScore for 10.1101/2022.01.23.22269669: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    EthicsConsent: Discontinuation of participation may also occur if (i) death; (ii) discharge from the aged care facility; or (iii) withdrawal of consent by the participant.
    Sex as a biological variableSecondary outcomes: Statistics: Sample size calculation: Available data on normal levels of T-cell subset CD28null indicated the standard deviation for males and females aged 60-80-year-old is 16% and 21% for those aged 80-100 years.
    RandomizationTrial design and population: This is a 12-week parallel group single-blinded (only assessors blinded) randomised controlled trial involving 160 older adults living in aged-care, randomised to either two daily doses of a multi-nutrient supplement (treatment) (Appendix 1) or usual care (control) (Figure 1).
    BlindingTrial design and population: This is a 12-week parallel group single-blinded (only assessors blinded) randomised controlled trial involving 160 older adults living in aged-care, randomised to either two daily doses of a multi-nutrient supplement (treatment) (Appendix 1) or usual care (control) (Figure 1).
    Power Analysis60 Assuming a standard deviation of 20%, to detect a 10% difference with 80% power at the 5% significance level, 128 participants will be required.
    Cell Line AuthenticationAuthentication: Serum vitamin D, calcium and albumin will be assayed at Dorevitch Pathology (Melbourne, Australia) using validated techniques.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    The dose used in this study is the amount recommended by the manufacturer (Abbott Pharmaceuticals, Australia).
    Abbott Pharmaceuticals
    suggested: None
    Automatic validation syntax set within REDCap will check for data discrepancies and generating appropriate error messages will allow for data to be confirmed or corrected.
    REDCap
    suggested: (REDCap, RRID:SCR_003445)

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

    Results from LimitationRecognizer: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.

    Results from TrialIdentifier: No clinical trial numbers were referenced.

    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

    Results from JetFighter: We did not find any issues relating to colormaps.

    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • No protocol registration statement was detected.

    Results from scite Reference Check: We found no unreliable references.

    About SciScore

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  3. Version published to 10.1101/2022.01.23.22269669v1 on medRxiv