ImmunosenescencePhase 2NCT02554188
Fasting-mimicking Diet and Immunosenescence
A Phase 2 study testing Seasonal influenza (flu) vaccine and Diet in people with Immunosenescence, run by University of Southern California.
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). Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Immunosenescence
- What is being tested?
- Seasonal influenza (flu) vaccine and Diet
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2019to 1 May 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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;
About this study
Official title: Effect of Fasting-mimicking Diet on Immunosenescence and Vaccination in Older Adults: A Randomized Clinical Trial
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).
Read the 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.
- Conditions
- Immunosenescence
- Being tested
- Seasonal influenza (flu) vaccine, Diet
- Keywords
- Dietary Intervention, Fasting-mimicking, Influenza Vaccines
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seasonal influenza (flu) vaccineBiological
Also called Flu shot
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
DietOther
A 5-day low calorie fasting-mimicking diet
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Participants will receive Seasonal influenza (flu) vaccine. Receives: 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. Receives: Biological: Seasonal influenza (flu) vaccine; Other: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (5)
Body composition changes
Body composition changes, measured as BMI, waist to hip ratio
Measured: 3 months
Physiological changes
Physiological changes measured as blood chemistry and motor performance
Measured: 3-6 months
Health outcomes
Health outcomes measured by SF-36 Health survey.
Measured: 3-12 months
Flu incidence and severity questionnaire
Self-reporting of flu incidence; Self-reporting of flu symptom severity on a 0-5 scale.
Measured: 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).
Measured: up to 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2015 (estimated)
- Study start1 May 2019
- Primary completion1 May 2019
- Study completion1 May 2019
Why it stopped: USC has an ICOI because the university owns the patent of the interventional dietary supplement.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunosenescenceStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebastian Brandhorst, University of Southern California
- Investigators
- Elizabeth Zelinski, PhD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02554188
- Sponsor's protocol ID
- HS-16-00467
- Status last verified
- Oct 2019
- First submitted
- 15 Sep 2015
- Last updated
- 30 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fasting-mimicking Diet on Immunosenescence and Vaccination in Older Adults: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02554188
- Acronym / sponsor ID
- HS-16-00467
- Conditions
- Immunosenescence
- Keywords
- Dietary Intervention, Fasting-mimicking, Influenza Vaccines
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: USC has an ICOI because the university owns the patent of the interventional dietary supplement.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 18 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Biological: Seasonal influenza (flu) vaccineParticipants will receive Seasonal influenza (flu) vaccine. |
| Diet | Experimental | Biological: Seasonal influenza (flu) vaccine, Other: DietParticipants 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. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Seasonal influenza (flu) vaccineAlso: Flu shotSeasonal 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 | Biological | Control, Diet |
| DietA 5-day low calorie fasting-mimicking diet | Other | Diet |
Primary outcome
Anti-Influenza Serum antibody titers 4 weeks after flu vaccination
Time frame: 3 months
* The ratio of post vaccine to pre vaccine titers will be calculated * A positive titer is defined as 1:40 or greater.
5 secondary outcomes
Body composition changes
Time frame: 3 months
Physiological changes
Time frame: 3-6 months
Health outcomes
Time frame: 3-12 months
Flu incidence and severity questionnaire
Time frame: up to 1 years
Dry eye surveys
Time frame: up to 1 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2019.
- Individual participant dataSharing planned: No
Related trials for Immunosenescence
RecruitingPhase 1/2
Precision Microbiota Interventions for Senoreduction Trial
HIV Infections, Alcohol Drinking
Not yet recruitingObservational study
Immune Aging and Advanced Therapy Outcomes in Older Adults With IBD
Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), Frailty
RecruitingPhase 4
Influenza Vaccine Immunogenicity in Repeatedly Vaccinated Older Adults
Influenza Vaccination, Older Adults (65 Years and Older)
Recruiting
Can Exercise Ameliorate Immunosenescence and Thereby Reduce Relapse in Head and Neck Cancer Patients
Aging, High-intensity Interval Training
RecruitingObservational study
Exploratory Study on Infection and Immunosenescence Based on an Elderly Clinical Cohort
Immunosenescence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Zelinski, PhD principal investigator
University of Southern California
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Seasonal influenza (flu) vaccine and Diet in people with Immunosenescence, run by University of Southern California.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-Influenza Serum antibody titers 4 weeks after flu vaccination (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2019.