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

Pharmacokinetic Effect of AstraGin on Arginine Absorption and Nitric Oxide Production in Healthy Subjects: A Randomized, Double-blind, Crossover Trial

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 Overview

• Status: Enrolling by invitation
• Conditions: Absorption of Amino Acids and Peptides
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: AstraGin

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan
    • Chung Shan Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; Before each study day, the participants were subjected to a reduced nitrate content diet (avoid foods such as dark chocolate, beets, garlic, nuts and seeds, bacon, ham, and hot dogs,, day-1) for 24h. All subjects took a 50 mg placebo (maltodextrin) capsule at 9 p.m. and began fasting for 12 hours, except for a small amount of water in the night before the experiment. On each study day, all subjects collected their first blood sample at 9 a.m. from the median cubital vein using the indwelling catheter method. After the first blood collection, all subjects took 50 mg placebo and 5 g of L-arginine with 250 mL water. Additional blood samples were collected at 0, 15, 30, 45, 60, 90, 120, 150, and 180 min for analysis of the plasma concentration of amino acids, total nitrite, nitrate, and asymmetric dimethylarginine (ADMA) content. All subjects collected their urine during 0 ~ 180 min to measure 1) nitrate and 2) cGMP content.
Experimental: Experimental	Dietary supplement: AstraGin; Before each study day, the participants were subjected to a reduced nitrate content diet (avoid foods such as dark chocolate, beets, garlic, nuts and seeds, bacon, ham, and hot dogs,, day-1) for 24h. All subjects took a 50 mg placebo (maltodextrin) capsule at 9 p.m. and began fasting for 12 hours, except for a small amount of water in the night before the experiment. On each study day, all subjects collected their first blood sample at 9 a.m. from the median cubital vein using the indwelling catheter method. After the first blood collection, all subjects took 50 mg placebo and 5 g of L-arginine with 250 mL water. Additional blood samples were collected at 0, 15, 30, 45, 60, 90, 120, 150, and 180 min for analysis of the plasma concentration of amino acids, total nitrite, nitrate, and asymmetric dimethylarginine (ADMA) content. All subjects collected their urine during 0 ~ 180 min to measure 1) nitrate and 2) cGMP content.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chung Shan Medical University

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2021
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: May 20, 2021
• First Submitted That Met QC Criteria: August 26, 2021
• First Posted (Actual): August 27, 2021

Study Record Updates

• Last Update Posted (Actual): August 27, 2021
• Last Update Submitted That Met QC Criteria: August 26, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: pharmacokinetic; nitric oxide; arginine; AstraGin
• Other Study ID Numbers: CS2-20203

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No