Fasting-mimicking Diet and Immunosenescence

NCT02554188 | Withdrawn Phase 2 DMC

• 1 other identifier: HS-16-00467
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Immunosenescence

Keywords

Dietary Intervention; Fasting-mimicking; Influenza Vaccines

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Body composition changes

  3 months

• Physiological changes

  3-6 months

• Health outcomes

  3-12 months

• Flu incidence and severity questionnaire

  up to 1 years

• Dry eye surveys

  up to 1 years

Study Arms (2)

Control

PLACEBO COMPARATOR

Participants will receive Seasonal influenza (flu) vaccine.

Biological: Seasonal influenza (flu) vaccine

Diet

EXPERIMENTAL

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; Other: Diet

Interventions

Seasonal influenza (flu) vaccine BIOLOGICAL

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

Also known as: Flu shot

Control; Diet

Diet OTHER

A 5-day low calorie fasting-mimicking diet

Diet

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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;

Sponsors & Collaborators

• University of Southern California: lead

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines; Vaccines; Diet

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Biological Products; Complex Mixtures; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Elizabeth Zelinski, PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Research Professor

Study Record Dates

• First Submitted: September 15, 2015
• First Posted: September 18, 2015
• Study Start: May 1, 2019
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: October 30, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share