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

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.

Study Overview

• Status: Withdrawn
• Conditions: Immunity
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Protocatechuic Acid or PCA

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Hershey Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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).	Dietary supplement: Placebo; Placebo capsule
Experimental: 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).	Dietary supplement: Protocatechuic Acid or PCA; PCA 1000 mg capsule

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Investigators: Principal Investigator: Raghu Sinha, PhD, Penn State College of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: October 29, 2023
• First Submitted That Met QC Criteria: November 2, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: dietary supplement, protocatechuic acid, immunity markers
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Antineoplastic Agents; Protective Agents; Anticarcinogenic Agents; Protocatechuic acid
• Other Study ID Numbers: STUDY00022594

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No