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

Not Applicable

Withdrawn

• Conditions: Immunity

• 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.

Study Timeline

• Study First Submitted: 2023-10-29
• Study First Submitted QC: 2023-11-02
• Study First Posted: 2023-11-07
• Status Verified: 2024-03
• Study Start: 2024-03
• Last Update Submitted: 2024-03-27
• Last Update Posted: 2024-03-29
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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