Healthy ageing. Immune ageing Other
Conditions
Interventions
Arm 1: Polyamine supplement – 6mg supplement taken orally for 13 weeks after a licensed flu vaccine. Follow-up for 37 weeks in total.
Arm 2: Placebo – 6mg of a rice flour placebo taken orally for 13
Sponsors
Cardiff University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 65 years of age or over 2. Capacity to provide written informed consent 3. Eligible for a seasonal flu vaccine 4. Willing to receive a licensed flu vaccine as part of the study protocol on visit 1 of the protocol
Exclusion criteria
Exclusion criteria: 1. Acutely unwell 2. Had a flu vaccine in the 6 months prior to recruitment 3. Known to be immunosuppressed 4. History of influenza in the 6 months prior to recruitment 5. Cannot provide informed written consent 6. Not willing to receive a licensed flu vaccine as part of the study protocol on visit 1 of the protocol 7. Use systemic steroids for more than one week e.g., prednisolone >0.5mg/kg/day in the three months prior to first study intervention 8. Chronic administration (=14 days in total) of immunosuppressants or other immune modifying drugs in the 3 months prior to first study intervention 9. Receipt of blood, blood products and/or plasma derivatives or any immunoglobulin preparation in the three months prior to first study intervention 10. Diagnosed with diabetes 11. Diagnosed with allergy to, or constituent parts of, SpermidineLife supplements or who have gluten intolerance 12. Already taking Spermidine supplements at the time of recruitment or for 6 months prior to recruitment to the study 13. In custody 14. Currently participating in other interventional trials 15. Do not live in Wales
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility measures: 1.Data from the IRFLUVA study case report forms will be used to measure study recruitment rates and retention rates. 2.Data from the IRFLUVA study case report forms will be used to measure study withdrawals and the reason for withdrawal. 3.Data from the IRFLUVA study case report forms will be used to measure the number, severity and nature of adverse reactions for all participants at baseline, 2 weeks, 13 weeks and 37 weeks. 4.Data from the IRFLUVA study case report form will be used to measure the number, severity and nature of adverse events for all participants at baseline, 2 weeks, 13 weeks and 37 weeks. 5.Data from the IRFLUVA study case report form will be used to measure Compliance with polyamine supplement and placebo supplements from baseline to week 13. 6.Results from biochemistry and haematology profile testing at baseline, 2 weeks, 13 weeks and 37 weeks. 7.The number of protocol deviations will be measured at the end of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured for up to 37 weeks: 1. T cell Elispots to measure responses to flu 2. B cell Elispots to measure B cell responses to flu 3. IgG ELISA to measure antibodies to flu 4. Plaque assays to study neutralizing antibodies 5. Cytokine assays to measure cytokine responses | — |
Countries
United Kingdom, Wales
Contacts
Public ContactLucy Jones
Outcome results
None listed