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

NCT05024123 | Unknown DMC

• 1 other identifier: CS2-20203
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Absorption of Amino Acids and Peptides

Keywords

AstraGin; arginine; pharmacokinetic; nitric oxide

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Experimental

EXPERIMENTAL

Dietary Supplement: AstraGin

Interventions

Placebo DIETARY_SUPPLEMENT

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.

Placebo

AstraGin DIETARY_SUPPLEMENT

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

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• The subject is participating in another clinical trial thirty days prior to enroll-ment.
• 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.

Sponsors & Collaborators

• Chung Shan Medical University: lead

Study Sites (1)

Chung Shan Medical University

Taichung, Taiwan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: August 27, 2021
• Study Start: April 6, 2021
• Primary Completion: October 1, 2021
• Study Completion: May 1, 2022
• Last Updated: August 27, 2021

Record last verified: 2021-08

Locations

TW (1)