Fasting-mimicking Diet and Immunosenescence

Immunosenescence Clinical Trial

Official title:

Effect of Fasting-mimicking Diet on Immunosenescence and Vaccination in Older Adults: A Randomized Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02554188
• Other study ID #: HS-16-00467
• Status: Withdrawn
• Phase: Phase 2
• Start date: May 1, 2019
• Est. completion date: May 1, 2019

Study information

• Verified date: October 2019
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Immunosenescence

Intervention

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:
• Diet
A 5-day low calorie fasting-mimicking diet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Outcome

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