Clinical trial NCT02554188: Fasting-mimicking Diet and Immunosenescence
Official title: Effect of Fasting-mimicking Diet on Immunosenescence and Vaccination in Older Adults: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Immunosenescence
Keywords: Dietary Intervention
Fasting-mimicking
Influenza Vaccines
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2015-09-18
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Anti-Influenza Serum antibody titers 4 weeks after flu vaccination
timeFrame: 3 months
Secondary outcomes:
measure: Body composition changes
timeFrame: 3 months
measure: Physiological changes
timeFrame: 3-6 months
measure: Health outcomes
timeFrame: 3-12 months
measure: Flu incidence and severity questionnaire
timeFrame: up to 1 years
measure: Dry eye surveys
timeFrame: up to 1 years
Other outcomes:
Locations:
Study officials:
affiliation: University of Southern California
name: Elizabeth Zelinski, PhD
role: PRINCIPAL_INVESTIGATOR
References: