Pharmacokinetic Effect of AstraGin on Arginine Absorption and Nitric Oxide Production in Healthy Subjects: A Randomized, Double-blind, Crossover Trial
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Maximum Plasma Concentration [Cmax]
Study Overview
Brief Summary
AstraGin increases the absorption of amino acids and peptides in Caco-2 cells and in normal and TNBS-induced rats. Given the potential beneficial applications of AstraGin for health, the effects on L-arginine uptake and nitric oxide production are investigated. The study is the L-arginine pharmacokinetic study: A randomized, double-blind, crossover trial. This study performed in healthy human subjects. The knowledge gained from this study will provide valuable information for the development of novel and effective natural food supplements.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy adults and age 20 years and above, subdivided into three groups, Early-life (younger than 45 years, midlife (45--65 years), and later-life (older than 65 years), respectively.
- •Subject has provided written and dated informed consent to participate in the study.
- •The subject is willing and able to comply with the study.
Exclusion Criteria
- •The subject is participating in another clinical trial thirty days prior to enroll-ment.
- •Subject has diabetes, obesity, hypertension, cardiovascular disease, liver or kid-ney disease, current infections, and smoking were exclusion criteria.
- •Subject has any medical condition or uses any medication, nutritional product, amino acids supplement or program which might interfere with the conduct of the study or place the subject at risk.
- •Subjects lost to follow-up, non-compliance, concomitant medication.
Arms & Interventions
Placebo
Intervention: Placebo (Dietary Supplement)
Experimental
Intervention: AstraGin (Dietary Supplement)
Outcomes
Primary Outcomes
Maximum Plasma Concentration [Cmax]
Time Frame: 3 hours
Pharmacokinetic ( 0, 15, 30, 45, 60, 90, 120, 150, and 180 minutes)
Maximum Time [Tmax]
Time Frame: 3 hours
Pharmacokinetic ( 0, 15, 30, 45, 60, 90, 120, 150, and 180 minutes)
Secondary Outcomes
No secondary outcomes reported
Investigators
You-Cheng Shen
Associate Professor
Chung Shan Medical University