Effect of Protocatechuic Acid on Biochemical Markers of Immunity Status in Healthy Adults

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Protocatechuic Acid on Biochemical Markers of Immunity Status in Healthy Adults

Conditions
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Immunity

Intervention / Treatment
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* Dietary Supplement: Protocatechuic Acid or PCA
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>The placebo pill is made of inactive cellulose. Participants will be asked to take 2 capsules daily by mouth in the morning 30 minutes before eating for a total of 14 days (Day 1 - Day 14). | Dietary Supplement: Placebo<br>* Placebo capsule<br>|
| Experimental: Protocatechuic Acid or PCA<br>Participants will be asked to take 2 capsules (500 mg each of protocatechuic acid or PCA) daily by mouth in the morning 30 minutes before eating for a total of 14 days (Day 1 - Day 14). | Dietary Supplement: Protocatechuic Acid or PCA<br>* PCA 1000 mg capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erythrocyte Sedimentation Rate | ESR (mm/hr) | Baseline and end of 2 weeks | 
| high sensitivity C-Reactive Protein | hsCRP (mg/L) | Baseline and end of 2 weeks | 
| Chemokine (C-X-C motif) ligand 9 | CXCL9 (ng/mL) | Baseline and end of 2 weeks | 
| 25-hydroxy vitamin D | 25-hydroxy vitamin D (ng/mL) | Baseline and end of 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-Chair test | participant moves 5 times between two chairs placed 5 feet apart, and heart rate and saturation of oxygen (SpO2 %) levels are measured | Baseline and end of 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dietary supplement, protocatechuic acid, immunity markers