Fasting-mimicking Diet and Immunosenescence

Phase 2

Withdrawn

• Conditions: Immunosenescence
• Interventions: Biological: Seasonal influenza (flu) vaccine; Other: Diet

• Registration Number: NCT02554188
• Lead Sponsor: University of Southern California

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2015-09-15
• Study First Submitted QC: 2015-09-16
• Study First Posted: 2015-09-18
• Study Start: 2019-05-01
• Primary Completion: 2019-05-01
• Study Completion: 2019-05-01
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-28
• Last Update Posted: 2019-10-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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;

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Seasonal influenza (flu) vaccine	Participants will receive Seasonal influenza (flu) vaccine.
Diet	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.
Diet	Seasonal influenza (flu) vaccine	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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