Immunity
Conditions
Keywords
dietary supplement, protocatechuic acid, immunity markers
Brief summary
The purpose of this voluntary research study is to determine if a dietary supplement containing a substance called protocatechuic acid (PCA) can change markers in blood related to immunity (a body's natural ability to fight diseases and infections) over a 14-day study period. Blood tests and other assessments will be completed before and after taking either 1,000 milligrams a day of protocatechuic acid (PCA) or a placebo (i.e., a sugar pill) for 14 days.
Detailed description
In this pilot study, the Investigator will utilize a double-blind placebo-controlled randomized design. Fifty (50) healthy men and women will be randomized into one of two arms: either agreeing to take placebo or 1000 mg PCA oral capsules daily. Study treatment will continue for 2 weeks (14 days). At baseline and end of 2 weeks treatment period, various clinical and laboratory measurements will be performed. Vital signs, a 2-chair test, and personal health assessment will be measured, and blood will be drawn. The following endpoints will be evaluated in blood: erythrocyte sedimentation rate (ESR), high sensitivity C-reactive protein (hsCRP), C-X-C motif chemokine ligand 9 (CXCL9), 25-hydroxy vitamin D.
Interventions
DIETARY_SUPPLEMENTProtocatechuic Acid or PCA
PCA 1000 mg capsule
DIETARY_SUPPLEMENTPlacebo
Placebo capsule
Sponsors
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
This study is a double-blind design. Neither the subject nor the research team will know which treatment arm (placebo or PCA) the enrolled subjects have been assigned to. Study drug bottles will be labeled with a code, and the linked treatment assignment (placebo vs PCA) will be kept with the Sponsor and not made available to the research team during the treatment period.
Intervention model description
We will assign subjects to the placebo or PCA supplementation randomly using Statistical Analysis System (SAS) software that contains a random assignment generator. It will output 50 assignments, equal to the number of subjects that we expect to enroll. Subjects will be assigned to one of the groups in a prospective manner as they are recruited throughout the study period.
Eligibility
Sex/Gender
ALL
Age
50 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy (i.e., no acute/new symptoms of illness) male and female volunteers * Ability to provide informed consent and attend study visits * Adults 50 - 65 years old * Has not taken any of the following medications in prior 3 months and has no plan to take over the 2-week study period: corticosteroids, anticoagulants (such as aspirin, clopidogrel, heparin, and warfarin), antibiotics, or daily NSAIDs (occasional use is acceptable) * Has no ill person currently living in household * Current non-smoker (and has not smoked cigarettes/cigars/pipes or vaped e-cigarettes within the last 6 months) * Ambulatory without any type of assistance
Exclusion criteria
* Cannot provide written informed consent * Requires assistance ambulating * Has had any surgery within last 3 months * Self-report of close exposure to or infection with COVID-19 (with or without symptoms) within last 3 months * Self-reported history or current status of cancer, uncontrolled diabetes (A1c \> 7% or fasting blood glucose of \> 140 mg/dL), or heart disease (such as coronary artery disease, arrhythmia, and heart failure)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Erythrocyte Sedimentation Rate | Baseline and end of 2 weeks | ESR (mm/hr) |
| high sensitivity C-Reactive Protein | Baseline and end of 2 weeks | hsCRP (mg/L) |
| Chemokine (C-X-C motif) ligand 9 | Baseline and end of 2 weeks | CXCL9 (ng/mL) |
| 25-hydroxy vitamin D | Baseline and end of 2 weeks | 25-hydroxy vitamin D (ng/mL) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 2-Chair test | Baseline and end of 2 weeks | participant moves 5 times between two chairs placed 5 feet apart, and heart rate and saturation of oxygen (SpO2 %) levels are measured |
Countries
United States
Outcome results
None listed