RECRUITINGINTERVENTIONAL
VITAL: Vaccination, Immunity, Time-restricted Eating, Aging and Lifestyle
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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 willing to sign a consent form
- 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
Who Should NOT Join This Trial:
- 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 conditions (where your immune system attacks your own body)
- 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
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
BEHAVIORAL
TRE: Time-restricted eating
The daily eating pattern is reduced to 8 h/day. The first meal will be before 10:00 AM.
Locations (1)
Clinical Research Unit, Experimental & Clinical Research Center, Campus Buch, Charité
Berlin, Germany