VaccinationVITALNCT07000708
VITAL: Vaccination, Immunity, Time-restricted Eating, Aging and Lifestyle
A study testing TRE: Time-restricted eating in people with Vaccination and Immunosenescence, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaccination, Immunosenescence, Metabolism
- What is being tested?
- TRE: Time-restricted eating
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- 10 Sep 2025to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Clinical Research Unit, Experimental & Clinical Research Center, Campus Buch, Charité
Berlin, 13125
Sylvia Bähring, PD Dr., +4930450540214, ecrc-cru@charite.de
About this study
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.
Read the detailed description
Aging impairs immune cell autophagy and reduces vaccine efficacy, leaving older adults highly vulnerable to influenza and other infectious diseases. Time-Restricted Eating (TRE), by limiting daily food intake to an 8-hour window without detailed calorie counting, modulates nutrient-sensing pathways (e.g., mTOR inhibition, AMPK activation) and boosts autophagic flux in preclinical models. In a randomized, controlled trial, healthy volunteers aged 60-85 will follow either four weeks of TRE or their usual eating pattern. After that, all will receive a standard seasonal vaccines against influenza and COVID-19 outside of the trial at their general practitioner (min. 2 days and max. 14 days after the stop of intervention). Blood and physiologic measurements at baseline, after four weeks of study intervention will quantify autophagy in immune cells, metabolome/proteome shifts, body composition, blood pressure, and arterial stiffness, among others. At two additional visits after the vaccination (2 weeks and 12-14 weeks after the vaccination), immune responses to the vaccination will be monitored in the blood. The investigators hypothesize that TRE-induced restoration of autophagy and amelioration of immunosenescence will correlate with stronger vaccine responses, offering a simple, low-cost strategy to rejuvenate immunity and improve preventive care in the elderly.
- Conditions
- Vaccination, Immunosenescence, Metabolism
- Being tested
- TRE: Time-restricted eating
- Keywords
- fasting, vaccination, intermittent fasting, time-restricted eating, influenza, immunity, aging, immunosenescence
- Medical subject headings
- Fasting, Intermittent Fasting, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRE: Time-restricted eatingBehavioural
The daily eating pattern is reduced to 8 h/day. The first meal will be before 10:00 AM.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: TRE: Time-restricted eating |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to 4 weeks
Secondary outcomes (44)
Change in body weight
Change in body weight
Measured: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in body composition (BodPod)
Change in body composition (e.g., fat and lean body mass), assessed via Air Displacement Plethysmography (ADP, BodPod).
Measured: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in body composition (BIA)
Change in body composition (e.g., fat and lean body mass), assessed via bioimpedance analysis (BIA).
Measured: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in the differential blood count
Change in the differential blood count, assessed with Hematology analyzers.
Measured: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in blood glucose levels
Change in blood glucose levels, assessed via routine blood diagnostic tests
Measured: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in insulin metabolism
Changes in insulin metabolism parameters, including insulin, IGF-1, C-peptide, ghrelin, leptin, adiponectin, and glucagon, assessed via ELISAs
Measured: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Changes in blood ketone body levels
Changes in blood ketone body levels (3-hydroxybutyrate, acetoacetate, acetone), assessed using commercially available assay kits
Measured: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in blood lipid profile
Changes in blood lipids assessed via metabolomics and routine blood diagnostic tests
Measured: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in liver or renal function
Changes in blood parameters of liver and renal function assessed via routine blood diagnostic tests
Measured: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in blood electrolyte levels
Changes in blood electrolyte levels assessed via routine blood diagnostic tests
Measured: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in the incidence of clinically diagnosable infections during the study period
Change in the incidence of clinically diagnosable infections during the study period, assessed at study visits by the study physician
Measured: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in continuous blood glucose levels
Change in continuous blood glucose levels, assessed with continuous glucose monitors (CGM). CGMs will be applied at V1 and V2 and record continuous glucose levels for 14 days each.
Measured: CGMs will be applied at V1 and V2 and record continuous glucose levels for 14 days each.
Change in grip strength
Change in grip strength, assessed with a dynamometer. Handgrip strength will be measured using a dynamometer three times sequentially and repeated after 1 hour.
Measured: Change from baseline to 4 weeks (end of TRE).
Change in metabolic rate
Change in metabolic rate via indirect calorimetry. Indirect calorimetry will be performed to assess energy expenditure as well as carbohydrate and fat oxidation rates. During the procedure, the subject will rest quietly in bed while wearing a ventilated hood. The hood is equipped with an inlet and an outlet valve. Through the inlet valve, the subject receives a constant supply of fresh air, while exhaled air is collected via the outlet valve. Sampling at the rear of the calorimetry device allows determination of gas concentrations in the ambient room air. By calculating the difference, oxygen consumption (VO₂) and carbon dioxide production (VCO₂) in ml/min are determined. These volumes enable the calculation of energy expenditure and substrate oxidation rates. This measurement is performed after a rest period of 30 minutes to determine resting fasting energy expenditure (duration approximately 30 minutes).
Measured: Change from baseline to 4 weeks (end of TRE).
Change in Sleep Quality
Change in Sleep Quality assessed using a questionnaire for the Pittsburgh Sleep Quality Index [PSQI].
Measured: Change from baseline to 4 weeks (end of TRE)
Change in health-related quality of life
Change in EQ-5D-5L assessed using questionnaires.
Measured: Change from baseline to 4 weeks (end of TRE)
Change in ChronoType
Change in ChronoType assessed using the Munich ChronoType Questionnaire [MCTQ]
Measured: Change from baseline to 4 weeks (end of TRE)
Change in the Multidimensional Prognostic Index (MPI).
Change in the MPI for geriatric assessment. MPI assessments will be conducted, including documentation of medication and dietary supplement use, medication allergies, nutritional therapies, a range of disease symptoms, social history, activities of daily living (ADL), instrumental activities of daily living (IADL), malnutrition screening, the Short Portable Mental Status Questionnaire (SPMSQ), and the Exton Smith Scale (assessment of decubitus risk), all administered via standardized questionnaires.
Measured: Change from baseline to 4 weeks
Change in the walking speed.
A 10-meter walk test will be performed to determine walking speed in m/s. For this purpose, the subject will walk from a 0-meter mark to a 10-meter mark upon command. Timing will begin at the 2-meter mark. The procedure will be repeated three times, and the times will be averaged. If the subject's fitness level permits, the procedure will be repeated with the instruction to complete the 10 meters 'as fast as possible while still feeling safe'.
Measured: Change from baseline to 4 weeks
Change in proteome profiles in plasma and PBMCs.
Change in proteome profiles in plasma and PBMCs, measured by LC-MS mass spectrometry or Olink proteomics.
Measured: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in metabolite patterns in plasma.
Change in metabolite patterns in plasma, assessed by untargeted (¹H-NMR) and/or targeted (LC-MS) metabolomics.
Measured: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in metabolite patterns in stool.
Change in metabolite patterns in stool, assessed by untargeted (¹H-NMR) and/or targeted (LC-MS) metabolomics.
Measured: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in metabolite patterns in urine.
Change in metabolite patterns in urine, assessed by untargeted (¹H-NMR) and/or targeted (LC-MS) metabolomics.
Measured: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in gut microbiome composition.
Change in gut microbiome composition by metagenomic sequencing of stool.
Measured: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in immune-cell subset distribution and activation.
Change in immune-cell subset distribution and activation, assessed by scRNA-seq and flow cytometry.
Measured: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in body fat percentage.
Change in body fat percentage, measured by air-displacement plethysmography.
Measured: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in office systolic and diastolic blood pressure.
Change in office systolic and diastolic blood pressure (mmHg), measured by non-invasive blood pressure cuff.
Measured: Change from baseline to 4 weeks
Change in pulse-wave velocity.
Change in pulse-wave velocity (m/s), measured by PulsePen.
Measured: Change from baseline to 4 weeks
Change in frequency of pro- and anti-inflammatory immune cells.
Change in frequency of pro- and anti-inflammatory immune cells in PBMCs, by flow cytometric immunophenotyping.
Measured: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in immune-cell function.
Change in immune-cell function (cytokine production, proliferation) after in vitro stimulation of PBMC subsets, by flow cytometry.
Measured: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in circulating pro- and anti-inflammatory cytokine concentrations in plasma.
Change in circulating pro- and anti-inflammatory cytokine concentrations in plasma, by multiplex cytokine assay.
Measured: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in expression of senescence markers in immune-cell subsets.
Change in expression of senescence markers in immune-cell subsets, by flow cytometry.
Measured: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in the hypusination status of eIF5A in PBMCs
Change in the hypusination status of eIF5A in PBMCs by flow cytometry.
Measured: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in mTOR activity status in PBMCs
Change in mTOR activity status in PBMCs by flow cytometry.
Measured: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in expression of key autophagy-regulatory genes.
Change in expression of key autophagy-regulatory genes in specific immune-cell types or bulk PBMCs, by qPCR, scRNA-seq, or bulk RNA-seq.
Measured: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in energy metabolism in immune-cell subsets.
Change in cellular energy metabolism in immune-cell subsets, measured by Seahorse extracellular flux analysis and/or Scenith Assay in isolated immune cells ex vivo.
Measured: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in coagulation.
Change in coagulation, assessed via e.g., thrombin generation, d-dimers from plasma
Measured: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in influenza-specific B- and T-cell responses.
Change in influenza-specific B- and T-cell responses in serum and PBMCs (e.g., ELISpot).
Measured: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in SARS-CoV-2 specific B- and T-cell responses.
Change in SARS-CoV-2 specific B- and T-cell responses in serum and PBMCs (e.g., ELISpot).
Measured: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in concentration of influenza-specific IgG antibodies.
Change in concentration of influenza-specific IgG antibodies, by ELISA.
Measured: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in concentration of SARS-CoV-2 specific IgG antibodies.
Change in concentration of SARS-CoV-2 specific IgG antibodies, by ELISA.
Measured: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in concentration of influenza-neutralizing antibodies.
Change in concentration of influenza-neutralizing antibodies.
Measured: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in concentration of SARS-CoV-2 neutralizing antibodies.
Change in concentration of SARS-CoV-2 neutralizing antibodies.
Measured: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in DNA-break profiles in primary B cells.
Change in DNA-break profiles in primary B cells, assessed by SWIBRID (Switch-joint Breakpoint Repertoire Identification).
Measured: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start10 Sep 2025
- Primary completionSep 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaccinationStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Max Delbrück Center for Molecular Medicine (MDC), Berlin, Labor Berlin, Germany, Experimental & Clinical Research Center Berlin, University of Oxford, University of Cologne
- Responsible party
- Principal investigator, Sebastian Hofer, Dr. rer. nat., Charite University, Berlin, Germany
- Investigators
- 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, GermanyAnna Katharina Simon, Prof. Dr., Principal investigator, Max-Delbrück Center for Molecular Medicine, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07000708
- Sponsor's protocol ID
- EA4/154/24
- Acronym
- VITAL
- Status last verified
- Sep 2025
- First submitted
- 30 Apr 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results of reported articles (text, tables, figures, supplemental data) will be shared after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VITAL: Vaccination, Immunity, Time-restricted Eating, Aging and Lifestyle
- ClinicalTrials.gov ID
- NCT07000708
- Acronym / sponsor ID
- VITAL / EA4/154/24
- Conditions
- Vaccination, Immunosenescence, Metabolism
- Keywords
- fasting, vaccination, intermittent fasting, time-restricted eating, influenza, immunity, aging, immunosenescence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Max Delbrück Center for Molecular Medicine (MDC), Berlin, Labor Berlin, Germany, Experimental & Clinical Research Center Berlin, University of Oxford, University of Cologne
- Study start
- 10 Sep 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 3 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Aging impairs immune cell autophagy and reduces vaccine efficacy, leaving older adults highly vulnerable to influenza and other infectious diseases. Time-Restricted Eating (TRE), by limiting daily food intake to an 8-hour window without detailed calorie counting, modulates nutrient-sensing pathways (e.g., mTOR inhibition, AMPK activation) and boosts autophagic flux in preclinical models. In a randomized, controlled trial, healthy volunteers aged 60-85 will follow either four weeks of TRE or their usual eating pattern. After that, all will receive a standard seasonal vaccines against influenza and COVID-19 outside of the trial at their general practitioner (min. 2 days and max. 14 days after the stop of intervention). Blood and physiologic measurements at baseline, after four weeks of study intervention will quantify autophagy in immune cells, metabolome/proteome shifts, body composition, blood pressure, and arterial stiffness, among others. At two additional visits after the vaccination (2 weeks and 12-14 weeks after the vaccination), immune responses to the vaccination will be monitored in the blood. The investigators hypothesize that TRE-induced restoration of autophagy and amelioration of immunosenescence will correlate with stronger vaccine responses, offering a simple, low-cost strategy to rejuvenate immunity and improve preventive care in the elderly.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: TRE: Time-restricted eatingFour weeks of TRE, where the daily eating pattern is reduced to 8 h/day. The first meal will be before 10:00 AM. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (25 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRE: Time-restricted eatingThe daily eating pattern is reduced to 8 h/day. The first meal will be before 10:00 AM. | Behavioural | TRE |
Primary outcome
Autophagic flux in PBMCs
Time frame: Change from baseline to 4 weeks
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.
44 secondary outcomes
Change in body weight
Time frame: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in body composition (BodPod)
Time frame: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in body composition (BIA)
Time frame: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in the differential blood count
Time frame: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in blood glucose levels
Time frame: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in insulin metabolism
Time frame: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Changes in blood ketone body levels
Time frame: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in blood lipid profile
Time frame: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in liver or renal function
Time frame: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in blood electrolyte levels
Time frame: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in the incidence of clinically diagnosable infections during the study period
Time frame: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in continuous blood glucose levels
Time frame: CGMs will be applied at V1 and V2 and record continuous glucose levels for 14 days each.
Change in grip strength
Time frame: Change from baseline to 4 weeks (end of TRE).
Change in metabolic rate
Time frame: Change from baseline to 4 weeks (end of TRE).
Change in Sleep Quality
Time frame: Change from baseline to 4 weeks (end of TRE)
Change in health-related quality of life
Time frame: Change from baseline to 4 weeks (end of TRE)
Change in ChronoType
Time frame: Change from baseline to 4 weeks (end of TRE)
Change in the Multidimensional Prognostic Index (MPI).
Time frame: Change from baseline to 4 weeks
Change in the walking speed.
Time frame: Change from baseline to 4 weeks
Change in proteome profiles in plasma and PBMCs.
Time frame: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in metabolite patterns in plasma.
Time frame: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in metabolite patterns in stool.
Time frame: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in metabolite patterns in urine.
Time frame: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in gut microbiome composition.
Time frame: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in immune-cell subset distribution and activation.
Time frame: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in body fat percentage.
Time frame: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in office systolic and diastolic blood pressure.
Time frame: Change from baseline to 4 weeks
Change in pulse-wave velocity.
Time frame: Change from baseline to 4 weeks
Change in frequency of pro- and anti-inflammatory immune cells.
Time frame: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in immune-cell function.
Time frame: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in circulating pro- and anti-inflammatory cytokine concentrations in plasma.
Time frame: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in expression of senescence markers in immune-cell subsets.
Time frame: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in the hypusination status of eIF5A in PBMCs
Time frame: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in mTOR activity status in PBMCs
Time frame: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in expression of key autophagy-regulatory genes.
Time frame: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in energy metabolism in immune-cell subsets.
Time frame: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in coagulation.
Time frame: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in influenza-specific B- and T-cell responses.
Time frame: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in SARS-CoV-2 specific B- and T-cell responses.
Time frame: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Change in concentration of influenza-specific IgG antibodies.
Time frame: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results of reported articles (text, tables, figures, supplemental data) will be shared after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
Anna Katharina Simon, Prof. Dr. principal investigator
Max-Delbrück Center for Molecular Medicine, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRE: Time-restricted eating in people with Vaccination and Immunosenescence, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sebastian Hofer, Dr. rer. nat. (+493094062372, sebastian.hofer@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Autophagic flux in PBMCs (time frame: Change from baseline to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025; AzTrials last refreshed its copy on 7 Nov 2026.