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

Conditions

Absorption of Amino Acids and Peptides

Keywords

AstraGin, arginine, pharmacokinetic, nitric oxide

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.

Ching‐Pin Lin, C.L. Lin, I‐Chin Wu, Ting-Yn Pan, You‐Cheng Shen

Functional Foods in Health and Disease2023-06-161 citations

10.31989/ffhd.v13i6.1104

Interventions

DIETARY_SUPPLEMENTPlacebo

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_SUPPLEMENTAstraGin

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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

Taiwan

Outcome results

None listed