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

NCT07000708 | Recruiting

• 1 other identifier: EA4/154/24
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaccination; Immunosenescence; Metabolism

Keywords

fasting; vaccination; intermittent fasting; time-restricted eating; influenza; immunity; aging; immunosenescence

Outcome Measures

Primary Outcomes (1)

• Autophagic flux in PBMCs

  Change in autophagic flux in peripheral immune cells from baseline (V1) to four weeks (V2), comparing the TRE group versus control, as measured by flow cytometry detection of LC3-II accumulation via antibody staining.

  Change from baseline to 4 weeks

Secondary Outcomes (44)

• Change in body weight

  Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination

• Change in body composition (BodPod)

  Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination

• Change in body composition (BIA)

  Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination

• Change in the differential blood count

  Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination

• Change in blood glucose levels

  Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination

Study Arms (2)

Control (no intervention)

NO INTERVENTION

Four weeks of ad libitum eating pattern with eating time window \>11 h/day. No change of the regular eating pattern.

TRE

EXPERIMENTAL

Four weeks of TRE, where the daily eating pattern is reduced to 8 h/day. The first meal will be before 10:00 AM.

Behavioral: TRE: Time-restricted eating

Interventions

TRE: Time-restricted eating BEHAVIORAL

The daily eating pattern is reduced to 8 h/day. The first meal will be before 10:00 AM.

TRE

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Max Delbrück Center for Molecular Medicine (MDC), Berlin: collaborator
• Labor Berlin, Germany: collaborator
• Experimental & Clinical Research Center Berlin: collaborator
• University of Oxford: collaborator
• University of Cologne: collaborator

Study Sites (1)

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

Berlin, 13125, Germany

RECRUITING

MeSH Terms

Conditions

Fasting; Intermittent Fasting; Influenza, Human

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Sebastian Hofer, Dr. rer. nat.

  Clinical Research Unit, Experimental and Clinical Research Center, Charité, Berlin, Germany & Max-Delbrück Center for Molecular Medicine, Berlin, Germany

  PRINCIPAL INVESTIGATOR

• Anna Katharina Simon, Prof. Dr.

  Max-Delbrück Center for Molecular Medicine, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sebastian Hofer, Dr. rer. nat.

CONTACT

+493094062372; sebastian.hofer@charite.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. rer. nat.

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: June 3, 2025
• Study Start: September 10, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: Researchers who provide a methodologically and scientifically sound proposal.

Locations

DE (1)