FIT to Grow Old - Functionality of the Immune System and Healthy Aging (NCT05940337) | Clinical Trial Compass
CompletedNot Applicable
FIT to Grow Old - Functionality of the Immune System and Healthy Aging
Netherlands156 participantsStarted 2020-11-11
Plain-language summary
Aging is commonly associated with reduced functionality of the immune system, resulting in a higher prevalence of infectious disease, auto-immune disease, cancer, and lower efficiency of vaccination. Nutritional strategies are increasingly recognized as a method to improve immune functionality, as several nutrients are shown to exert immunomodulatory properties. However, the large variation between individuals with regard to immune responses asks for more personalized approaches. Therefore, this field of research would benefit from a selection of those individuals with immune dysfunction. It is recently shown that immune functionality is largely dependent on intracellular metabolism, leading to the introduction of the new term 'immune cell fitness' which combines the metabolic and functional status of an immune cell. Within this study, we will determine the immune cell fitness of monocytes from healthy young adults and elderly subjects by measuring and integrating a broad range of metabolic and functional immune parameters into an immune cell fitness score. We aim to identify those individuals with immune dysfunction, the unfit. Furthermore, to identify potential nutritional strategies to improve immune cell fitness, we will study the effects of metabolites and nutrients on the immune cell fitness status of monocytes from elderly subjects.
Who can participate
Age range
20 Years – 75 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 20 - 30y and 60 - 75y
* BMI 18.5 - 25 kg/m2 (young adults); 20 - 30 kg/m2 (elderly)
* Willing to fast overnight for 12 hours
* Willing to give a blood sample
* Having a general practitioner
* Signed informed consent
Exclusion Criteria:
* Diagnosed with metabolic and/or inflammatory disease (e.g. diabetes, cardiovascular disease (with the exception of hypertension), arthritis, arthrosis, glycogen storage dis-orders and auto-immune diseases)
* Current diagnosis of cancer
* Regular use of medication that interferes with immune function (e.g. corticosteroids, cytokine blockers)
* Regular use of medication that may interfere with metabolism (e.g. metabolic inhibitors or activators)
* Use of medication that interferes with immune function and metabolism in at least one week preceding the study visit (e.g. NSAID, anti-histamines, corticosteroids)
* More than 4kg weight gain or weight loss over the last 4 months
* Vaccination within 3 months preceding the study visit (e.g. immunization against influ-enza, pneumonia, and travel-related infections)
* Donated blood within 2 months preceding the study visit
* Pregnant, lactating or wishing to become pregnant in the period between the screening and study visit (self-reported)
* Regular use of hard drugs and soft drugs (i.e. weekly use) and at least no use within 2 months preceding the study visit
* Excessive alcohol use (i.e. \>14 units per week)
* Use of cigarettes and other tobacco products
* Participation i…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.