Actively Recruiting
VITAL: Vaccination, Immunity, Time-restricted Eating, Aging and Lifestyle
Led by Charite University, Berlin, Germany · Updated on 2025-09-18
24
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
Sponsors
C
Charite University, Berlin, Germany
Lead Sponsor
M
Max Delbrück Center for Molecular Medicine (MDC), Berlin
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the effects of a four-week time-restricted eating (TRE) intervention on immune cell autophagy, immune function, and vaccine responses in healthy older adults aged 60 to 85. The goal is to see if limiting daily food intake to an 8-hour window can improve the body's response to seasonal influenza and COVID-19 vaccines by enhancing immune system processes that decline with age. Participants will be randomly assigned to one of two groups: one group will maintain their usual eating pattern with a daily eating window longer than 11 hours, while the other group will follow TRE by limiting their daily eating to an 8-hour window, starting with the first meal before 10:00 AM. The intervention lasts four weeks, after which all participants will receive standard influenza and COVID-19 vaccinations arranged with their primary care doctors. Throughout the study, participants will undergo blood tests and physiological measurements at baseline, after the four-week eating intervention, and at two follow-up visits after vaccination (2 weeks and 12-14 weeks later). Researchers will monitor changes in autophagy in immune cells, body composition, blood pressure, metabolic markers, immune responses to vaccines, and other health indicators. This trial aims to provide insights into how TRE might support immune health and vaccine effectiveness in older adults.
CONDITIONS
Brief Title
VITAL: Vaccination, Immunity, Time-restricted Eating, Aging and Lifestyle
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female participants enrolled in a 1:1 ratio
- Age 60 to 85 years
- Body mass index (BMI) between 20 and 35 kg/m²
- Ability to give informed consent
- Existing health insurance for evaluation and treatment of incidental findings
- Usual daily eating window longer than 11 hours
- First meal before 10:00 AM
- Willingness to receive seasonal influenza and COVID-19 vaccinations with proof of appointment
- Ability and willingness to follow an 8-hour daily eating window with 16-hour fasting
- Pre-arranged appointment for simultaneous influenza and COVID-19 vaccination coordinated with the study team
You will not qualify if you...
- Vaccination against influenza or COVID-19 within 6 months before intervention
- Any unrelated vaccinations during study period
- History of influenza infection within 6 months prior to study
- Severe adverse reactions to previous vaccinations
- Use of pharmacological weight-loss drugs
- Diabetes treated with medication
- Symptoms of systemic inflammatory or autoimmune diseases
- Immunosuppression or use of immunosuppressive drugs
- Severe hypertension (systolic > 180 mmHg or diastolic > 110 mmHg)
- Medical conditions preventing study participation as judged by physician
- Participation in any fasting or diet program within 6 months before enrollment
- Night-shift or rotating-shift work
- Severe, active, or unstable medical conditions requiring treatment
- Recent postoperative recovery
- Antibiotic therapy within 3 months before enrollment
- Acute or chronic infections
- Special therapeutic or medically prescribed diets
- Vegan diet
- Current smoker
- Weight change over 2 kg in the month before enrollment
- Known substance, drug, or alcohol abuse
- Anemia
- Claustrophobia
- Legal incapacity or inability to understand study nature and implications
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants follow either four weeks of time-restricted eating (TRE) with an 8-hour daily eating window starting before 10:00 AM, or continue their usual eating pattern.
1 baseline visit and 1 visit after 4 weeks
Duration - Approximately 12 to 14 weeks
Participants receive standard seasonal influenza and COVID-19 vaccines at their general practitioner 2 to 14 days after completing the eating pattern intervention. Immune responses to the vaccination are monitored.
2 visits (at 2 weeks and 12-14 weeks after vaccination)
Trial Site Locations
Total: 1 location
1
Clinical Research Unit, Experimental & Clinical Research Center, Campus Buch, Charité
Berlin, Germany, 13125
Actively Recruiting
Research Team
S
Sebastian Hofer, Dr. rer. nat.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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