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USC has an ICOI because the university owns the patent of the interventional dietary supplement.
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | Participants will receive Seasonal influenza (flu) vaccine. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Seasonal influenza (flu) vaccine | Biological | Seasonal influenza (flu) vaccine
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| Measure | Description | Time Frame |
|---|---|---|
| Anti-Influenza Serum antibody titers 4 weeks after flu vaccination |
| 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Body composition changes | Body composition changes, measured as BMI, waist to hip ratio | 3 months |
| Physiological changes | Physiological changes measured as blood chemistry and motor performance |
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Inclusion Criteria:
Exclusion Criteria:
Concomitant medications
Safety-based exclusions:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Zelinski, PhD | University of Southern California | Principal Investigator |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| D014612 | Vaccines |
| D004032 | Diet |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D009747 | Nutritional Physiological Phenomena |
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|
| Diet | Other | A 5-day low calorie fasting-mimicking diet |
|
| 3-6 months |
| Health outcomes | Health outcomes measured by SF-36 Health survey. | 3-12 months |
| 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 |
| 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 |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |