Effect of Protocatechuic Acid on Biochemical Markers of Immunity Status in Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Erythrocyte Sedimentation Rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Erythrocyte Sedimentation Rate
时间窗: Baseline and end of 2 weeks
ESR (mm/hr)
25-hydroxy vitamin D
时间窗: Baseline and end of 2 weeks
25-hydroxy vitamin D (ng/mL)
high sensitivity C-Reactive Protein
时间窗: Baseline and end of 2 weeks
hsCRP (mg/L)
Chemokine (C-X-C motif) ligand 9
时间窗: Baseline and end of 2 weeks
CXCL9 (ng/mL)
次要结局
- 2-Chair test(Baseline and end of 2 weeks)
研究者
Raghu Sinha
Associate Professor of Biochemistry and Molecular Biology
Milton S. Hershey Medical Center