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

Immunity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT06121362
• Other study ID #: STUDY00022594
• Status: Withdrawn
• Phase: N/A
• Start date: March 2024
• Est. completion date: March 2025

Study information

• Verified date: March 2024
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Immunity

Intervention

Dietary Supplement:
• Protocatechuic Acid or PCA
PCA 1000 mg capsule
• Placebo
Placebo capsule

Locations

Country	Name	City	State
United States	Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Erythrocyte Sedimentation Rate	ESR (mm/hr)	Baseline and end of 2 weeks
Primary	high sensitivity C-Reactive Protein	hsCRP (mg/L)	Baseline and end of 2 weeks
Primary	Chemokine (C-X-C motif) ligand 9	CXCL9 (ng/mL)	Baseline and end of 2 weeks
Primary	25-hydroxy vitamin D	25-hydroxy vitamin D (ng/mL)	Baseline and end of 2 weeks
Secondary	2-Chair test	participant moves 5 times between two chairs placed 5 feet apart, and heart rate and saturation of oxygen (SpO2 %) levels are measured	Baseline and end of 2 weeks