Fasting-mimicking Diet and Immunosenescence

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University of Southern California

Status and phase

Withdrawn
Phase 2

Conditions

Immunosenescence

Treatments

Other: Diet
Biological: Seasonal influenza (flu) vaccine

Study type

Interventional

Funder types

Other

Identifiers

NCT02554188
HS-16-00467

Details and patient eligibility

About

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).

Full 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.

Sex

All

Ages

50 to 75 years old

Volunteers

Accepts Healthy Volunteers

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;

Trial design

0 participants in 2 patient groups, including a placebo group

Control
Placebo Comparator group
Description:
Participants will receive Seasonal influenza (flu) vaccine.
Treatment:
Biological: Seasonal influenza (flu) vaccine
Diet
Experimental group
Description:
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.
Treatment:
Biological: Seasonal influenza (flu) vaccine
Other: Diet

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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