Clinical trial NCT06121362: Effect of Protocatechuic Acid on Biochemical Markers of Immunity Status in Healthy Adults
Official title: Effect of Protocatechuic Acid on Biochemical Markers of Immunity Status in Healthy Adults
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Immunity
Keywords: dietary supplement, protocatechuic acid, immunity markers
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Erythrocyte Sedimentation Rate
timeFrame: Baseline and end of 2 weeks
measure: high sensitivity C-Reactive Protein
timeFrame: Baseline and end of 2 weeks
measure: Chemokine (C-X-C motif) ligand 9
timeFrame: Baseline and end of 2 weeks
measure: 25-hydroxy vitamin D
timeFrame: Baseline and end of 2 weeks
Secondary outcomes:
measure: 2-Chair test
timeFrame: Baseline and end of 2 weeks
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Penn State College of Medicine
name: Raghu Sinha, PhD
role: PRINCIPAL_INVESTIGATOR
References: