VITAL: Vaccination, Immunity, Time-restricted Eating, Aging and Lifestyle
Recruiting now · Not applicable
Conditions studied: Vaccination, Immunosenescence, Metabolism
In brief
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.
Key facts
- Study ID
- NCT07000708
- Run by
- Charite University, Berlin, Germany
- People needed
- 24
- Starts
- 2025-09-10
- Expected to finish
- 2027-01-01
- Last updated by the study team
- 2025-09-18
Who can join
Age: 60 and older, up to 85. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Clinical Research Unit, Experimental & Clinical Research Center, Campus Buch, Charité — Berlin, Germany (enrolling)
Full record on ClinicalTrials.gov
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