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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-31

Study Completion Date

2025-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Immunity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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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).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo capsule

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).

Group Type EXPERIMENTAL

Protocatechuic Acid or PCA

Intervention Type DIETARY_SUPPLEMENT

PCA 1000 mg capsule

Interventions

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Protocatechuic Acid or PCA

PCA 1000 mg capsule

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo capsule

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)

Minimum Eligible Age

50 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes