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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое TRE: Time-restricted eating
  The daily eating pattern is reduced to 8 h/day. The first meal will be before 10:00 AM.

Первичные конечные точки

• Autophagic flux in PBMCs [Срок оценки: Change from baseline to 4 weeks]

Вторичные конечные точки (12)

• Change in body weight [Срок оценки: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination]
• Change in body composition (BodPod) [Срок оценки: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination]
• Change in body composition (BIA) [Срок оценки: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination]
• Change in the differential blood count [Срок оценки: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination]
• Change in blood glucose levels [Срок оценки: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination]
• Change in insulin metabolism [Срок оценки: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination]
• Changes in blood ketone body levels [Срок оценки: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination]
• Change in blood lipid profile [Срок оценки: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination]
• Change in liver or renal function [Срок оценки: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination]
• Change in blood electrolyte levels [Срок оценки: 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 [Срок оценки: Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination]
• Change in continuous blood glucose levels [Срок оценки: CGMs will be applied at V1 and V2 and record continuous glucose levels for 14 days each.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Фундаментальное исследование

Центры проведения

Германия · 1 центр

• Clinical Research Unit, Experimental & Clinical Research Center, Campus Buch, Charité — Berlin

Идентификаторы

NCT: NCT07000708 · EA4/154/24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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