NCT02554188

Fasting-mimicking Diet and Immunosenescence

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Immunosenescence

Interventions

Type	Name	Description
BIOLOGICAL	Seasonal influenza (flu) vaccine	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
OTHER	Diet	A 5-day low calorie fasting-mimicking diet

Timeline

• Start date: 2019-05-01
• Primary completion: 2019-05-01
• Completion: 2019-05-01
• First posted: 2015-09-18
• Last updated: 2019-10-30