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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05024123
Recruitment Status : Enrolling by invitation
First Posted : August 27, 2021
Last Update Posted : August 27, 2021
Sponsor:
Information provided by (Responsible Party):
You-Cheng Shen, 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.

Condition or disease Intervention/treatment Phase
Absorption of Amino Acids and Peptides Dietary Supplement: Placebo Dietary Supplement: AstraGin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Pharmacokinetic Effect of AstraGin on Arginine Absorption and Nitric Oxide Production in Healthy Subjects: A Randomized, Double-blind, Crossover Trial
Actual Study Start Date : April 6, 2021
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


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.





Primary Outcome Measures :
  1. Maximum Plasma Concentration [Cmax] [ Time Frame: 3 hours ]
    Pharmacokinetic ( 0, 15, 30, 45, 60, 90, 120, 150, and 180 minutes)

  2. Maximum Time [Tmax] [ Time Frame: 3 hours ]
    Pharmacokinetic ( 0, 15, 30, 45, 60, 90, 120, 150, and 180 minutes)



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05024123


Locations
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Taiwan
Chung Shan Medical University
Taichung, Taiwan
Sponsors and Collaborators
Chung Shan Medical University
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Responsible Party: You-Cheng Shen, Associate Professor, Chung Shan Medical University
ClinicalTrials.gov Identifier: NCT05024123    
Other Study ID Numbers: CS2-20203
First Posted: August 27, 2021    Key Record Dates
Last Update Posted: August 27, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by You-Cheng Shen, Chung Shan Medical University:
AstraGin
arginine
pharmacokinetic
nitric oxide