Fasting-mimicking Diet and Immunosenescence

University of Southern California

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Conditions

Immunosenescence

Interventions

Seasonal influenza (flu) vaccineBIOLOGICAL

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

DietOTHER

A 5-day low calorie fasting-mimicking diet

Eligibility

Sex: ALLMin age: 50 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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;

Outcomes

Primary Outcomes

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.

Time frame: 3 months

Secondary Outcomes

Body composition changes

Body composition changes, measured as BMI, waist to hip ratio

Time frame: 3 months

Physiological changes

Physiological changes measured as blood chemistry and motor performance

Time frame: 3-6 months

Health outcomes

Health outcomes measured by SF-36 Health survey.

Time frame: 3-12 months

Flu incidence and severity questionnaire

Self-reporting of flu incidence; Self-reporting of flu symptom severity on a 0-5 scale.

Time frame: 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).

Time frame: up to 1 years

Data from ClinicalTrials.gov

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