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

NCT06121362 | Withdrawn

• 1 other identifier: STUDY00022594
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Immunity

Keywords

dietary supplement, protocatechuic acid, immunity markers

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• 2-Chair test

  Baseline and end of 2 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Protocatechuic Acid or PCA

EXPERIMENTAL

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

Interventions

Protocatechuic Acid or PCA DIETARY_SUPPLEMENT

PCA 1000 mg capsule

Protocatechuic Acid or PCA

Placebo DIETARY_SUPPLEMENT

Placebo capsule

Placebo

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Interventions

protocatechuic acid; Passive Cutaneous Anaphylaxis

Intervention Hierarchy (Ancestors)

Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques; Antigen-Antibody Reactions; Immune System Phenomena

Study Officials

• Raghu Sinha, PhD

  Penn State College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study is a double-blind design. Neither the subject nor the research team will know which treatment arm (placebo or PCA) the enrolled subjects have been assigned to. Study drug bottles will be labeled with a code, and the linked treatment assignment (placebo vs PCA) will be kept with the Sponsor and not made available to the research team during the treatment period.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Biochemistry and Molecular Biology

Model Details: 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.

Study Record Dates

• First Submitted: October 29, 2023
• First Posted: November 7, 2023
• Study Start: March 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: March 29, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)