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

NCT05024123 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-08-27

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Chung Shan Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-06
Primary Completion
2021-10-31
Completion
2022-05-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05024123 on ClinicalTrials.gov