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

Sponsor

Milton S. Hershey Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06121362

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Immunity	Dietary Supplement: Protocatechuic Acid or PCA Dietary Supplement: Placebo	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Basic Science

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Jan 1, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Erythrocyte Sedimentation Rate [Baseline and end of 2 weeks]
ESR (mm/hr)
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)
25-hydroxy vitamin D [Baseline and end of 2 weeks]
25-hydroxy vitamin D (ng/mL)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hershey Medical Center	Hershey	Pennsylvania	United States	17033

Sponsors and Collaborators

Milton S. Hershey Medical Center

Investigators

Principal Investigator: Raghu Sinha, PhD, Penn State College of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Raghu Sinha, Associate Professor of Biochemistry and Molecular Biology, Milton S. Hershey Medical Center

ClinicalTrials.gov Identifier:

NCT06121362

Other Study ID Numbers:

STUDY00022594

First Posted:

Nov 7, 2023

Last Update Posted:

Nov 7, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Raghu Sinha, Associate Professor of Biochemistry and Molecular Biology, Milton S. Hershey Medical Center

dietary supplement, protocatechuic acid, immunity markers

Additional relevant MeSH terms:

Protocatechuic acid

Study Results

No Results Posted as of Nov 7, 2023