RecruitingNot ApplicableNCT07000708
VITAL: Vaccination, Immunity, Time-restricted Eating, Aging and Lifestyle
Sponsor
Charite University, Berlin, Germany
Enrollment
24 participants
Start Date
Sep 10, 2025
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 60 YearsMax Age: 85 Years
Inclusion Criteria10
- 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 Criteria25
- 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
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Interventions
BEHAVIORALTRE: Time-restricted eating
The daily eating pattern is reduced to 8 h/day. The first meal will be before 10:00 AM.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07000708
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