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

Penn State Health

Status: Withdrawn

Conditions: Immunity

Treatments: Dietary Supplement: Protocatechuic Acid or PCA; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06121362

STUDY00022594

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 50 to 65 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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).

Treatment:

Dietary Supplement: Placebo

Protocatechuic Acid or PCA

Experimental group

Description:

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).

Treatment:

Dietary Supplement: Protocatechuic Acid or PCA