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A clinical evaluation to determine the safety, pharmacokinetics and pharmacodynamics of an inositol‐stabilized arginine silicate dietary supplement in healthy adult males. (LB418)
Author(s) -
Kalman Douglas,
Feldman Samantha,
Samson Adam,
Krieger Diane
Publication year - 2014
Publication title -
the faseb journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.709
H-Index - 277
eISSN - 1530-6860
pISSN - 0892-6638
DOI - 10.1096/fasebj.28.1_supplement.lb418
Subject(s) - arginine , cmax , pharmacokinetics , medicine , nitric oxide , pharmacodynamics , endocrinology , nitrite , chemistry , biochemistry , amino acid , organic chemistry , nitrate
The purpose of this study was to characterize the PK/PD of Nitrosigine™, an inositol‐stabilized arginine silicate dietary supplement. Ten healthy males, 26.7 ± 5.4 years, took Nitrosigine™ qd for 14 days and attended test visits on Days 1 and 14. Fasting blood and saliva collections were performed pre‐dose and at 0.5, 1, 1.5, 2, 3, 4, 5 and 6 hours post‐dose for plasma arginine, serum silicon and salivary nitric oxide + nitrite (NO). After Day 1 dose, arginine levels increased (p<0.01) at 0.5, 1, 1.5, 2, 3 and 5 hours and silicon levels increased (p<0.05) at 1 and 1.5 hours. Day 1 PK parameters for arginine were: CMax 27.25±4.86 µg/ml and tMax 1.05±0.50 and for silicon: CMax 2.77±0.74 µg/ml and tMax 2.15±1.75. After Day 14 dose, arginine levels increased (p<0.05) at 0.5, 1, and 1.5 hours, and silicon levels increased (p<0.01) at 1, 1.5, 2, and 3 hours. After 14 days of use, baseline arginine trended towards being higher than baseline Day 1 (p=0.0645), and 4‐hour post‐dose plasma arginine was significantly higher (p=0.0488). Although not a significant difference, NO increased in four subjects and stayed the same in six subjects at 0.5 hours after the first dose (p=0.125). After 14 days of use, baseline NO levels increased in six subjects and stayed the same in four subjects (p=0.031). No safety concerns were raised by this study.