Effect of Protocatechuic Acid on Biochemical Markers of Immunity Status in Healthy Adults
- Conditions
- Immunity
- Interventions
- Dietary Supplement: PlaceboDietary Supplement: Protocatechuic Acid or PCA
- Registration Number
- NCT06121362
- Lead Sponsor
- Milton S. Hershey Medical Center
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo 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). Protocatechuic Acid or PCA Protocatechuic Acid or PCA 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).
- Primary Outcome Measures
Name Time Method Erythrocyte Sedimentation Rate Baseline and end of 2 weeks ESR (mm/hr)
25-hydroxy vitamin D Baseline and end of 2 weeks 25-hydroxy vitamin D (ng/mL)
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)
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States