VITAL: Try time-restricted eating to improve vaccine responses in older adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In a randomized, controlled design, healthy volunteers aged 60–85 are assigned 1:1 to four weeks of time-restricted eating (8-hour eating window) or their usual eating pattern. After the intervention ends, participants receive standard seasonal influenza and COVID-19 vaccinations coordinated with their primary care physician (given 2–14 days after the intervention). Blood and physiologic measures are taken at baseline, after four weeks, and again at two follow-up visits 2 weeks and 12–14 weeks after vaccination to measure autophagy in immune cells, metabolome/proteome changes, body composition, blood pressure, arterial stiffness, and vaccine-specific immune responses. Investigators will correlate TRE-induced changes in autophagy and metabolism with the strength and durability of vaccine responses.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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's running

• Clinical Research Unit, Experimental & Clinical Research Center, Campus Buch, Charité
  Berlin, Germany Recruiting

Study contacts

• Principal investigator: Sebastian Hofer, Dr. rer. nat. — Clinical Research Unit, Experimental and Clinical Research Center, Charité, Berlin, Germany & Max-Delbrück Center for Molecular Medicine, Berlin, Germany
• Study coordinator: Sebastian Hofer, Dr. rer. nat.
• Email: sebastian.hofer@charite.de
• Phone: +493094062372

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.