Status:
RECRUITING
VITAL: Vaccination, Immunity, Time-restricted Eating, Aging and Lifestyle
Lead Sponsor:
Charite University, Berlin, Germany
Collaborating Sponsors:
Max Delbrück Center for Molecular Medicine (MDC), Berlin
Labor Berlin, Germany
Conditions:
Vaccination
Immunosenescence
Eligibility:
All Genders
60-85 years
Phase:
NA
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 va...
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 foo...
Eligibility Criteria
Inclusion
- 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
- 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 study physician, preclude participation in the study
- Participation in any fasting intervention (e.g., TRE, alternate-day fasting, 5:2, 18:6) within 6 months before enrollment
- Participation in another diet or weight-loss program (e.g., intensive athletic training)
- Night-shift or rotating-shift work
- Severe, active, or unstable medical conditions requiring treatment
- Postoperative recovery phase
- Antibiotic therapy within 3 months before enrollment
- Acute or chronic infections
- Therapeutic or medically prescribed special diets
- Vegan diet
- Current smoker
- Weight change \> 2 kg in the month before enrollment
- Known substance, drug, or alcohol abuse
- Anemia
- Claustrophobia
- Legal incapacity or any other circumstance that prevents full understanding of the nature, importance, and implications of the study
Key Trial Info
Start Date :
September 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT07000708
Start Date
September 10 2025
End Date
January 1 2027
Last Update
September 18 2025
Active Locations (1)
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1
Clinical Research Unit, Experimental & Clinical Research Center, Campus Buch, Charité
Berlin, Germany, 13125