Fasting-mimicking Diet and Immunosenescence

• Sponsor: University of Southern California (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT02554188
• Collaborator: (none)
• Enrollment: 0
• Arms: 2

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Immunosenescence	Biological: Seasonal influenza (flu) vaccine; Other: Diet	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Effect of Fasting-mimicking Diet on Immunosenescence and Vaccination in Older Adults: A Randomized Clinical Trial
• Actual Study Start Date: May 1, 2019
• Actual Primary Completion Date: May 1, 2019
• Actual Study Completion Date: May 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. Body composition changes [3 months]

   Body composition changes, measured as BMI, waist to hip ratio

2. Physiological changes [3-6 months]

   Physiological changes measured as blood chemistry and motor performance

3. Health outcomes [3-12 months]

   Health outcomes measured by SF-36 Health survey.

4. 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.

5. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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;

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Southern California

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sebastian Brandhorst, Assistant Research Professor, University of Southern California
• ClinicalTrials.gov Identifier: NCT02554188
• Other Study ID Numbers: HS-16-00467
• First Posted: Sep 18, 2015
• Last Update Posted: Oct 30, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sebastian Brandhorst, Assistant Research Professor, University of Southern California: Dietary Intervention; Fasting-mimicking; Influenza Vaccines

Study Results

No Results Posted as of Oct 30, 2019