TY - JOUR
T1 - 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)
T2 - protocol for a randomised controlled trial
AU - Al Saedi, Ahmed
AU - Kirk, Ben
AU - Iuliano, Sandra
AU - Zanker, Jesse
AU - Vogrin, Sara
AU - Jayaram, Lata
AU - Thomas, Shane
AU - Golding, Christine
AU - Navarro-Perez, Diana
AU - Marusic, Petra
AU - Leng, Sean
AU - Nanan, Ralph
AU - Duque, Gustavo
N1 - Funding Information:
Competing interests GD and SI-B serve as members of the Advisory Board of Abbott Australia. GD serves on the Scientific Advisory Board at TSI Pharmaceuticals. BK is currently supported by a research fellowship from TSI Pharmaceuticals. All the other authors declare that they have no competing interests.
Funding Information:
Funding This study was funded by a grant from the Australian Medical Research Future Fund 2020; Rare Cancers Rare Diseases and Unmet Need (Grant number: 2005987). Sponsor: University of Melbourne (Melbourne, Australia) to AAS, SI and GD.
Publisher Copyright:
© 2022 Author(s) (or their employer(s)). Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2022/5/6
Y1 - 2022/5/6
N2 - Introduction 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.
AB - Introduction 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.
KW - COVID-19
KW - DIETETICS
KW - GERIATRIC MEDICINE
KW - IMMUNOLOGY
KW - INFECTIOUS DISEASES
KW - NUTRITION
UR - http://www.scopus.com/inward/record.url?scp=85130000828&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85130000828&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2021-059075
DO - 10.1136/bmjopen-2021-059075
M3 - Article
C2 - 35523505
AN - SCOPUS:85130000828
SN - 2044-6055
VL - 12
JO - BMJ open
JF - BMJ open
IS - 5
M1 - e059075
ER -