NCT07000708 VITAL: Vaccination, Immunity, Time-restricted Eating, Aging and Lifestyle
| NCT ID | NCT07000708 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Charite University, Berlin, Germany |
| Condition | Vaccination |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2025-09-10 |
| Primary Completion | 2026-09 |
Trial Parameters
Eligibility Fast-Check
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Brief 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.
Eligibility Criteria
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 with