VITAL: Vaccination, Immunity, Time-restricted Eating, Aging and Lifestyle
Germany24 participantsStarted 2025-09-10
Plain-language summary
The aim of this study is to investigate the effects of a four-week time-restricted eating (TRE) intervention on autophagy, immune function, and vaccine response to a seasonal influenza and COVID-19 vaccines in older healthy subjects.
Who can participate
Age range
60 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male and female participants, enrolled in a 1:1 ratio
* Age 60-85 years
* Body mass index (BMI) 20-35 kg/m²
* Capacity to give informed consent
* Existing health insurance to allow evaluation and treatment of any incidental findings
* Usual daily eating window \> 11 hours
* First meal of the day before 10:00 AM
* Willingness to receive seasonal influenza and COVID-19 vaccination and proof of scheduled appointment
* Willingness and ability to follow a prescribed TRE dietary regimen (8-hour daily eating window; 16-hour fast without any caloric intake)
* Appointment for simultaneous influenza and COVID-19 vaccination pre-arranged with primary care physician and coordinated with study team to align with TRE intervention
Exclusion Criteria:
* Any vaccination (especially influenza and/or COVID-19) within 6 months before the intervention start
* Vaccinations not related to the study, administered during the study period from V0 to V4
* History of influenza infection within 6 months prior to initiation of the study intervention
* History of severe adverse reactions to prior vaccinations
* Use of pharmacological weight-loss agents (e.g., semaglutide)
* Diabetes mellitus under ongoing pharmacological treatment
* Symptoms of systemic inflammatory or autoimmune disease
* Immunosuppression (including use of immunosuppressive drugs)
* Severe hypertension (systolic \> 180 mmHg or diastolic \> 110 mmHg)
* Diseases or functional disorders which, in the opinion of the …
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?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
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.