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临床试验/NCT07000708
NCT07000708招募中不适用

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

Charite University, Berlin, Germany1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年9月10日最近更新:
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适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
24
试验地点
1
主要终点
Autophagic flux in PBMCs
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Investigator)

入排标准

年龄范围
60 Years 至 85 Years（Adult, Older Adult）
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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
  • •Claustrophobia
  • •Legal incapacity or any other circumstance that prevents full understanding of the nature, importance, and implications of the study

研究组 & 干预措施

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.

干预措施: TRE: Time-restricted eating (Behavioral)

结局指标

主要结局

Autophagic flux in PBMCs

时间窗: 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.

次要结局

  • Change in immune-cell function.(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 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 from baseline to 4 weeks)
  • Change in pulse-wave velocity.(Change from baseline to 4 weeks)
  • Change in frequency of pro- and anti-inflammatory immune cells.(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 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 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 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 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 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 from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination)
  • Change in concentration of influenza-neutralizing antibodies.(Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination)
  • Change in the Multidimensional Prognostic Index (MPI).(Change from baseline to 4 weeks)
  • Change in DNA-break profiles in primary B cells.(Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination)
  • Change in body weight(Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination)
  • Change in body composition (BodPod)(Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination)
  • Change in body composition (BIA)(Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination)
  • Change in the differential blood count(Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination)
  • Change in blood glucose levels(Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination)
  • Change in insulin metabolism(Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination)
  • Changes in blood ketone body levels(Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination)
  • Change in blood lipid profile(Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination)
  • Change in liver or renal function(Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination)
  • Change in blood electrolyte levels(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 from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination)
  • Change in continuous blood glucose levels(CGMs will be applied at V1 and V2 and record continuous glucose levels for 14 days each.)
  • Change in grip strength(Change from baseline to 4 weeks (end of TRE).)
  • Change in metabolic rate(Change from baseline to 4 weeks (end of TRE).)
  • Change in Sleep Quality(Change from baseline to 4 weeks (end of TRE))
  • Change in health-related quality of life(Change from baseline to 4 weeks (end of TRE))
  • Change in ChronoType(Change from baseline to 4 weeks (end of TRE))
  • Change in the Multidimensional Prognostic Index (MPI).(Change from baseline to 4 weeks)
  • Change in the walking speed.(Change from baseline to 4 weeks)
  • Change in proteome profiles in plasma and PBMCs.(Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination)
  • Change in metabolite patterns in plasma.(Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination)
  • Change in metabolite patterns in stool.(Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination)
  • Change in metabolite patterns in urine.(Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination)
  • Change in gut microbiome composition.(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 from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination)
  • Change in body fat percentage.(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 from baseline to 4 weeks)
  • Change in pulse-wave velocity.(Change from baseline to 4 weeks)
  • Change in frequency of pro- and anti-inflammatory immune cells.(Change from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination)
  • Change in immune-cell function.(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 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 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 from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination)
  • Change in mTOR activity status in PBMCs(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 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 from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination)
  • Change in coagulation.(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 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 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 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 from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination)
  • Change in concentration of influenza-neutralizing antibodies.(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 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 from baseline to 4 weeks (end of TRE), 2 weeks and 12-14 weeks after vaccination)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sebastian Hofer, Dr. rer. nat.

Dr. rer. nat.

Charite University, Berlin, Germany

研究点 (1)

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