VITAL: Vaccination, Immunity, Time-restricted Eating, Aging and Lifestyle
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-85
SponsorCharite University, Berlin, Germany
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
TRE: Time-restricted eating
BehavioralThe daily eating pattern is reduced to 8 h/day. The first meal will be before 10:00 AM.
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Control (no intervention)No intervention 0 interventions
Group B: TREExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Change from baseline to 4 weeksSecondary outcomes
1
Change in body weight
Change in body weight
Time frame
Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination2
Change in body composition (BodPod)
Change in body composition (e.g., fat and lean body mass), assessed via Air Displacement Plethysmography (ADP, BodPod).
Time frame
Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination3
Change in body composition (BIA)
Change in body composition (e.g., fat and lean body mass), assessed via bioimpedance analysis (BIA).
Time frame
Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination4
Change in the differential blood count
Change in the differential blood count, assessed with Hematology analyzers.
Time frame
Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccinationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Charite University, Berlin, Germany
Lead sponsor
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
Source ClinicalTrials.gov