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

Milton S. Hershey Medical Center

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Conditions

Immunity

Interventions

Protocatechuic Acid or PCADIETARY_SUPPLEMENT

PCA 1000 mg capsule

PlaceboDIETARY_SUPPLEMENT

Placebo capsule

Eligibility

Sex: ALLMin age: 50 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Hershey Medical Center

Hershey, Pennsylvania, United States