Abstract

Inositol‐stabilized arginine silicate (ASI), branded as Nitrosigine®, is a popular nutritional ingredient found in pre‐workout products. It has been clinically shown to not only increase nitric oxide levels, but also increase energy levels and mental acuity and focus, and therefore acts as a non‐caffeinated energy source1,2. In addition, ASI intake has been shown in clinical and preclinical studies to improve markers associated with cardiovascular health3. However, the effects of ASI intake on heart rate and blood pressure have not been evaluated. Other energy‐stimulating ingredients, such as caffeine, bitter orange and guarana, have been shown to increase heart rate, blood pressure, insomnia, nervousness, and restlessness. Caffeine intake can increase systolic blood pressure by 10% and increase heart rate by 6% after only 60 minutes4. This current evaluation was conducted to review the safety data from clinical studies on ASI, to determine if ASI can be used as a non‐stimulant energy source without any negative cardiovascular side effects.In a double‐blind, placebo‐controlled, clinical study, 16 male subjects (18 to 35 years old) with previously limited exercise routines, received both test products (ASI 1500 mg and placebo) in a randomly assigned sequence, daily for 4 days. There was a seven‐day washout between test products. Changes in heart rate and blood pressure were measured from pre‐dose to approximately 25 minutes post dose on Day 1 and from pre‐dose Day 1 to pre‐dose Day 4. Results showed that while perceived energy levels increased in the ASI group compared to placebo after 72 hours (p<0.05), there were no significant changes in heart rate or systolic and diastolic blood pressure versus placebo at any measured time point.In another double‐blind, placebo‐controlled, clinical study, 12 male subjects (18 to 35 years old) with previously limited exercise routines received both test products (ASI 1500 mg and placebo) in a randomly assigned sequence, daily for 14 days. There was a seven‐day washout between test products. Changes in heart rate and blood pressure were measured from pre‐dose to approximately 25 minutes post dose on Day 1 and from pre‐dose Day 1 to pre‐dose Day 14. Results showed that there were no significant changes in heart rate or systolic and diastolic blood pressure within the ASI group or between groups at any measured time point.In conclusion, currently available data show that ASI intake at daily doses of 1500 mg does not induce elevations in heart rate or blood pressure. While intake of other known energy‐stimulating ingredients can increase heart rate and blood pressure even after a single dose, ASI intake did not change heart rate or blood pressure after both short term (after 25 minutes) and longer term (after 14 days) use. Overall, clinical and preclinical data suggest that ASI (Nitrosigine) can be safely used as a non‐stimulant ingredient to increase physical energy and cognitive function without adverse cardiovascular effects.Support or Funding InformationThis study was funded by Nutrition 21, LLC.This abstract is from the Experimental Biology 2018 Meeting. There is no full text article associated with this abstract published in The FASEB Journal.

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