VITAL: Try time-restricted eating to improve vaccine responses in older adults
VITAL: Vaccination, Immunity, Time-restricted Eating, Aging and Lifestyle
This will test whether four weeks of time-restricted eating (an 8-hour daily eating window) helps people aged 60–85 mount stronger immune responses to seasonal influenza and COVID-19 vaccines.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 60 Years to 85 Years |
| Sex | All |
| Sponsor | Charite University, Berlin, Germany Academic / other |
| Locations | 1 site (Berlin) |
| Trial ID | NCT07000708 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are generally healthy adults aged 60–85 with BMI 20–35 kg/m² who normally eat over an >11-hour window, have their first meal before 10:00 AM, can commit to an 8-hour eating window for four weeks, and are willing to receive seasonal influenza and COVID-19 vaccines as scheduled.
Not a fit: People who are immunosuppressed, have had recent vaccination (within 6 months), cannot safely fast for 16 hours daily, or cannot meet the timing/attendance requirements are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this could provide a simple, low-cost way to boost vaccine effectiveness and rejuvenate immune responses in older adults.
How similar studies have performed: Preclinical studies show TRE boosts autophagy and small human trials report metabolic gains, but robust evidence that TRE enhances vaccine responses in older adults is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Berlin
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.