Fasting-mimicking Diet and Immunosenescence

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

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).

Study Overview

• Status: Withdrawn
• Conditions: Immunosenescence
• Intervention / Treatment: Biological: Seasonal influenza (flu) vaccine; Other: Diet

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.

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control; Participants will receive Seasonal influenza (flu) vaccine.	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 Names: Flu shot
Experimental: 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.	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 Names: Flu shot; Other: Diet; A 5-day low calorie fasting-mimicking diet

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Southern California
• Investigators: Principal Investigator: Elizabeth Zelinski, PhD, University of Southern California

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): May 1, 2019

Study Registration Dates

• First Submitted: September 15, 2015
• First Submitted That Met QC Criteria: September 16, 2015
• First Posted (Estimate): September 18, 2015

Study Record Updates

• Last Update Posted (Actual): October 30, 2019
• Last Update Submitted That Met QC Criteria: October 28, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Dietary Intervention; Influenza Vaccines; Fasting-mimicking
• Other Study ID Numbers: HS-16-00467

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No