Actively Recruiting

Phase Not Applicable
Age: 60Years - 85Years
All Genders
Healthy Volunteers
NCT07000708

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

68 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

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.

CONDITIONS

Official Title

VITAL: Vaccination, Immunity, Time-restricted Eating, Aging and Lifestyle

Who Can Participate

Age: 60Years - 85Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 for evaluation and treatment of incidental findings
  • Usual daily eating window longer than 11 hours
  • First meal of the day before 10:00 AM
  • Willingness to receive seasonal influenza and COVID-19 vaccination with proof of scheduled appointment
  • Willingness and ability to follow a prescribed TRE dietary regimen (8-hour daily eating window; 16-hour fast without caloric intake)
  • Appointment for simultaneous influenza and COVID-19 vaccination pre-arranged with primary care physician and coordinated with study team
Not Eligible

You will not qualify if you...

  • 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 study start
  • History of severe adverse reactions to prior vaccinations
  • Use of pharmacological weight-loss agents (e.g., semaglutide)
  • Diabetes mellitus under 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 preventing study participation per physician
  • Participation in any fasting intervention within 6 months before enrollment
  • Participation in another diet or weight-loss program
  • 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 month before enrollment
  • Known substance, drug, or alcohol abuse
  • Anemia
  • Claustrophobia
  • Legal incapacity or inability to fully understand the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Clinical Research Unit, Experimental & Clinical Research Center, Campus Buch, Charité

Berlin, Germany, 13125

Actively Recruiting

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Research Team

S

Sebastian Hofer, Dr. rer. nat.

CONTACT

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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