NCT07000708

VITAL: Vaccination, Immunity, Time-restricted Eating, Aging and Lifestyle

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: All
• Age: 60 Years – 85 Years
• Healthy volunteers: Accepted

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.

Detailed description

Aging impairs immune cell autophagy and reduces vaccine efficacy, leaving older adults highly vulnerable to influenza and other infectious diseases. Time-Restricted Eating (TRE), by limiting daily food intake to an 8-hour window without detailed calorie counting, modulates nutrient-sensing pathways (e.g., mTOR inhibition, AMPK activation) and boosts autophagic flux in preclinical models. In a randomized, controlled trial, healthy volunteers aged 60-85 will follow either four weeks of TRE or their usual eating pattern. After that, all will receive a standard seasonal vaccines against influenza and COVID-19 outside of the trial at their general practitioner (min. 2 days and max. 14 days after the stop of intervention). Blood and physiologic measurements at baseline, after four weeks of study intervention will quantify autophagy in immune cells, metabolome/proteome shifts, body composition, blood pressure, and arterial stiffness, among others. At two additional visits after the vaccination (2 weeks and 12-14 weeks after the vaccination), immune responses to the vaccination will be monitored in the blood. The investigators hypothesize that TRE-induced restoration of autophagy and amelioration of immunosenescence will correlate with stronger vaccine responses, offering a simple, low-cost strategy to rejuvenate immunity and improve preventive care in the elderly.

Conditions

• Vaccination
• Immunosenescence
• Metabolism

Interventions

Type	Name	Description
BEHAVIORAL	TRE: Time-restricted eating	The daily eating pattern is reduced to 8 h/day. The first meal will be before 10:00 AM.

Timeline

• Start date: 2025-09-10
• Primary completion: 2026-09-01
• Completion: 2027-01-01
• First posted: 2025-06-03
• Last updated: 2025-09-18

Locations

1 site across 1 country: Germany