{"id":91,"date":"2024-08-21T18:32:23","date_gmt":"2024-08-21T17:32:23","guid":{"rendered":"https:\/\/blogs.cardiff.ac.uk\/irfluva-study\/?p=91"},"modified":"2025-01-22T09:27:26","modified_gmt":"2025-01-22T09:27:26","slug":"patient-information-sheet","status":"publish","type":"post","link":"https:\/\/blogs.cardiff.ac.uk\/irfluva-study\/patient-information-sheet\/","title":{"rendered":"PATIENT INFORMATION SHEET"},"content":{"rendered":"

We are actively looking for volunteers to take part in a study on healthy immune ageing. We aim to find out if a food supplement made from wheatgerm can increase the protective immune response to a normal flu vaccine in people aged over 65 years of age. The study starts on 30th September 2024 and you are able to register your interest in joining the study by calling 02921848251 or 07480926235 or emailing the study lead Dr Lucy Jones on JonesL147@cardiff.ac.uk.<\/strong> You may have already made an appointment to take part. The participant information sheet below provides more information about the study.<\/p>\n

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PARTICIPANT INFORMATION SHEET<\/span><\/b><\/p>\n

IRFLUVA – Improving the Long Term Immune Response to the Flu Vaccine<\/span><\/b>\u00a0<\/span><\/p>\n

Ethics reference: IRAS 314310<\/span>\u00a0<\/span><\/p>\n

We would like to invite you to take part in a research study led by Cardiff University, University of Oxford and Cardiff and the Vale University health board. It aims to learn more about the immune responses in older people. It is up to you to decide whether to take part. It is important for you to understand why the study is being done and what it will involve for you. Please take time to read the following information carefully and discuss it with others if you wish.\u00a0<\/span><\/p>\n

What is the purpose of the study?\u00a0<\/span><\/b>\u00a0<\/span><\/p>\n

Our immune response to viruses and bacteria (the way our body responds to infections) reduces as we age. This appears to be part of the normal aging process and can make ‘fighting’ infections more difficult. As you may already know, some infections can affect older people more seriously than people of a younger age, for example, flu and Coronavirus.\u00a0<\/span>\u00a0<\/span><\/p>\n

Vaccines are very important in older people. We have seen this with the UK vaccination programme for Coronavirus, where older people are made a high priority for timely vaccination. However, doctors and scientists have seen that the immune response to a vaccine can also be reduced in older people, when compared to younger people. This change in the immune response as we age is something we would like to understand more.<\/span>\u00a0<\/span><\/p>\n

There is new evidence that foods containing a substance called spermidine, may be an important part of a healthy diet and important for the immune response.\u00a0 Spermidine is naturally found in some foods, but not in large amounts. A widely available supplement, SPDLife, made from wheatgerm, contains spermidine and can increase the amount of spermidine eaten every day. It may improve the health of the immune system in older people. We would like to find out more about how older people find taking this\u00a0 supplement and explore if it can improve the immune response to the flu vaccine. It is not a medication and its safety has been studied carefully.\u00a0<\/span>\u00a0<\/span><\/p>\n

This research trial will look at if it is simple to take the supplement daily and whether older people find it acceptable. We will also explore whether it can improve the immune response in people aged more than 65 years old. If you take part, we will study the effect of this supplement on your immune response to the flu vaccine you are eligible to have every year.<\/span>\u00a0<\/span><\/p>\n

We will ask you your opinion about the supplement and we will measure your antibody responses and measure the immune cells responses to the flu vaccine This will include studying your white blood cells, which help fight infection and play an essential role in successful vaccination. By analysing a sample of blood, the research will look at how your body responds to the flu vaccine and whether the response is improved by taking the supplement and ensuring you have good amount of spermidine in your diet. We hope this trial will, therefore, give us more information about whether the food supplement can be used in a larger trial in the future and to see if it can improve the immune response to the flu vaccine in older people.<\/span>\u00a0<\/span><\/p>\n

What is the supplement used in this study?<\/span><\/b>\u00a0<\/span><\/p>\n

The supplement is made from wheatgerm. It is a powder that dissolves in water and can be taken by mouth at home. The ‘placebo’ is also a powder that dissolves in water and can be similarly taken by mouth at home. Studies have shown the supplement does not have any serious side effects. It also contains thiamine, Zinc and Vitamin C which are important parts of a healthy diet. The placebo contains rice flour and a small amount of sucrose (a type of sugar found in food).<\/span>\u00a0<\/span><\/p>\n

Why have I been chosen? <\/span><\/b>We are inviting people aged 65 years or over, who are eligible to have the flu vaccine every year, to take part in this study. <\/span>We are aiming to recruit a total of 80 participants to this research study. To take part you must:<\/span>\u00a0<\/span><\/p>\n\n\n\n
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  • Be aged 65 years or over.<\/span>\u00a0<\/span><\/li>\n<\/ul>\n

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  • Be eligible for a seasonal flu vaccine<\/span>\u00a0<\/span><\/li>\n<\/ul>\n

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  • Be willing to receive a normal, licensed flu vaccine<\/span>\u00a0<\/span><\/li>\n<\/ul>\n<\/td>\n
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