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

C

Chung Shan Medical University

Status

Unknown

Conditions

Absorption of Amino Acids and Peptides

Treatments

Dietary Supplement: AstraGin
Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT05024123
CS2-20203

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

20 to 80 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

30 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Treatment:
Dietary Supplement: Placebo
Experimental
Experimental group
Treatment:
Dietary Supplement: AstraGin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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