NCT07000708 VITAL: Vaccination, Immunity, Time-restricted Eating, Aging and Lifestyle
| NCT ID | NCT07000708 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Charite University, Berlin, Germany |
| Condition | Vaccination |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2025-09-10 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2025-09-10 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Sebastian Hofer, Dr. rer. nat.
PRINCIPAL INVESTIGATOR
Clinical Research Unit, Experimental and Clinical Research Center, Charité, Berlin, Germany & Max-Delbrück Center for Molecular Medicine, Berlin, Germany
Frequently Asked Questions
Who can join the NCT07000708 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, up to 85 Years, studying Vaccination. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07000708 currently recruiting?
Yes, NCT07000708 is actively recruiting participants. Contact the research team at sebastian.hofer@charite.de for enrollment information.
Where is the NCT07000708 trial being conducted?
This trial is being conducted at Berlin, Germany.
Who is sponsoring the NCT07000708 clinical trial?
NCT07000708 is sponsored by Charite University, Berlin, Germany. The principal investigator is Sebastian Hofer, Dr. rer. nat. at Clinical Research Unit, Experimental and Clinical Research Center, Charité, Berlin, Germany & Max-Delbrück Center for Molecular Medicine, Berlin, Germany. The trial plans to enroll 24 participants.