Effect of Fasting-mimicking Diet on Immunosenescence and Vaccination in Older Adults: A Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Anti-Influenza Serum antibody titers 4 weeks after flu vaccination
研究概览
简要总结
The objective of this study is to test a Fasting-Mimicking Diet (FMD) for its efficacy on improving immune response to flu vaccination in an older adult population (50-75 years of age).
详细描述
This is a randomized clinical trial to test the safety and efficacy of the fasting-mimicking diet (FMD) in an elderly population (50-75 years of age) receiving their annual influenza vaccination. The study will include two arms: Control (normal diet) and FMD (2 cycles of 5-day fasting-mimicking diet within two months). Participants both arms will receive the standard influenza vaccine.The primary endpoint is anti-influenza antibody titers measured 4 weeks after flu vaccination. Secondary endpoints include: (1) body composition changes, measured as BMI, waist to hip ratio; (2) physiological changes, measured as blood chemistry and motor performance; (3) health outcomes, measured by SF-36 Health survey, dry eye surveys and flu incidents within 12 months of vaccination.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability and willingness to provide written informed consent;
- •Ability and willingness to undergo 2 cycles of a 5-day dietary regimen;
- •Ability and willingness to provide blood samples via venipuncture;
- •Seeking to get a seasonal influenza vaccine.
排除标准
- •Concomitant medications
- •Received flu (influenza) shot for the flu season;
- •Receiving immunosuppressive therapy (i.e., oral prednisone in doses > 10 mg daily);
- •On immunosuppressive drugs for cancer or rheumatologic therapy;
- •Receiving insulin or octreotide;
- •On hypertension medication. The subject must obtain the treating doctor's approval prior to beginning the study.
- •Safety-based exclusions:
- •Hemoglobin < 9.0 g/dL;
- •White blood cell count < 3,500/mm^3;
- •Neutrophil count < 2,000/mm^3,
- •Platelet count < 125,000/mm^3;
- •Medical conditions that are incompatible with the dietary intervention ;
- •Medical conditions that are incompatible with the flu vaccination;
- •Pregnant or nursing female;
- •Alcohol dependency;
研究组 & 干预措施
Control
Participants will receive Seasonal influenza (flu) vaccine.
干预措施: Seasonal influenza (flu) vaccine (Biological)
Diet
Participants will consume 2 cycles of a 5-day low calorie fasting-mimicking diet with approximately 3 weeks of gap period prior to receiving standard Seasonal influenza (flu) vaccine.
干预措施: Seasonal influenza (flu) vaccine (Biological)
Diet
Participants will consume 2 cycles of a 5-day low calorie fasting-mimicking diet with approximately 3 weeks of gap period prior to receiving standard Seasonal influenza (flu) vaccine.
干预措施: Diet (Other)
结局指标
主要结局
Anti-Influenza Serum antibody titers 4 weeks after flu vaccination
时间窗: 3 months
* The ratio of post vaccine to pre vaccine titers will be calculated * A positive titer is defined as 1:40 or greater.
次要结局
- Body composition changes(3 months)
- Physiological changes(3-6 months)
- Health outcomes(3-12 months)
- Flu incidence and severity questionnaire(up to 1 years)
- Dry eye surveys(up to 1 years)
研究者
Sebastian Brandhorst
Assistant Research Professor
University of Southern California