Pharmacokinetic Effect of AstraGin on Arginine Absorption and Nitric Oxide Production in Healthy Subjects

Not Applicable

• Conditions: Absorption of Amino Acids and Peptides
• Interventions: Dietary Supplement: AstraGin; Dietary Supplement: Placebo

• Registration Number: NCT05024123
• Lead Sponsor: Chung Shan Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-06
• Study First Submitted: 2021-05-20
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-26
• Last Update Submitted: 2021-08-26
• Study First Posted: 2021-08-27
• Last Update Posted: 2021-08-27
• Primary Completion: 2021-10
• Study Completion: 2022-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Experimental	AstraGin	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Maximum Plasma Concentration [Cmax]	3 hours	Pharmacokinetic ( 0, 15, 30, 45, 60, 90, 120, 150, and 180 minutes)
Maximum Time [Tmax]	3 hours	Pharmacokinetic ( 0, 15, 30, 45, 60, 90, 120, 150, and 180 minutes)

Trial Locations

Locations (1)

Chung Shan Medical University; 🇨🇳 Taichung, Taiwan