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New treatment option for Vaccination
Official title VITAL: Vaccination, Immunity, Time-restricted Eating, Aging and Lifestyle
ClinicalTrials.gov ID: NCT07000708
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 to 85. Healthy volunteers may be eligible.
You may be able to join 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
You likely can't join 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Berlin, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years to 85 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Berlin, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.