Fasting-mimicking Diet and Immunosenescence

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Effect of Fasting-mimicking Diet on Immunosenescence and Vaccination in Older Adults: A Randomized Clinical Trial

Conditions
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Immunosenescence

Intervention / Treatment
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* Biological: Seasonal influenza (flu) vaccine
* Other: Diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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;

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Participants will receive Seasonal influenza (flu) vaccine. | Biological: Seasonal influenza (flu) vaccine<br>* Seasonal influenza (flu) vaccine Fluzone Quadrivalent Vaccine (Sanofi Pasteur), for participants ages 50 - 64 years old Fluzone High-Dose (Sanofi Pasteur), for participants ages 65 years and older<br>* Other names: Flu shot;|
| Experimental: Diet<br>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. | Biological: Seasonal influenza (flu) vaccine<br>* Seasonal influenza (flu) vaccine Fluzone Quadrivalent Vaccine (Sanofi Pasteur), for participants ages 50 - 64 years old Fluzone High-Dose (Sanofi Pasteur), for participants ages 65 years and older<br>* Other names: Flu shot;Other: Diet<br>* A 5-day low calorie fasting-mimicking diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-Influenza Serum antibody titers 4 weeks after flu vaccination | The ratio of post vaccine to pre vaccine titers will be calculated A positive titer is defined as 1:40 or greater. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition changes | Body composition changes, measured as BMI, waist to hip ratio | 3 months | 
| Physiological changes | Physiological changes measured as blood chemistry and motor performance | 3-6 months | 
| Health outcomes | Health outcomes measured by SF-36 Health survey. | 3-12 months | 
| Flu incidence and severity questionnaire | Self-reporting of flu incidence; Self-reporting of flu symptom severity on a 0-5 scale. | up to 1 years | 
| Dry eye surveys | Dry eye condition measured by the Ocular Surface Disease Index (OSDI) questionnaire and the Dry Dye Severity Questionnaire (DESQ). | up to 1 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dietary Intervention, Fasting-mimicking, Influenza Vaccines