Status:

WITHDRAWN

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

Lead Sponsor:

Milton S. Hershey Medical Center

Conditions:

Immunity

Eligibility:

All Genders

50-65 years

Phase:

NA

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 n...

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 tak...

Eligibility Criteria

Inclusion

  • 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

  • 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)

Key Trial Info

Start Date :

March 1 2024

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2025

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT06121362

Start Date

March 1 2024

End Date

March 1 2025

Last Update

March 29 2024

Active Locations (1)

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Hershey Medical Center

Hershey, Pennsylvania, United States, 17033