A Randomized, Double‐blind, Placebo‐controlled Study Comparing the Healthy Levels of Blood Sugar and Endothelial Function of PEAK ATP® with GlycoCarn®, PEAK ATP® and GlycoCarn® supplementation versus Placebo
Authors: Hirsh Steven , Huber Luke G. , Stein Richard A. , Schmid Kira , Swick Andrew , Joyal Steven V. 
Published: November 2023

Background

Oral intake of GlycoCarn® (Glycine Propionyl‐L‐Carnitine Hydrochloride) has been shown to improve the plasma nitrate/nitrite ratio, antioxidant defenses, and cardiovascular risk factors. Peak ATP®, the disodium salt of Adenosine 5′‐Triphosphate, increases extracellular ATP levels. Increases in extracellular ATP and its metabolite adenosine act through purinergic receptors, which are important for regulating inflammation, muscle contraction, neurotransmission, and sensory perception.

Objectives

This study investigated the effectiveness of PEAK ATP and GlycoCarn, separately and in combination, on cardiovascular health, general health, and sexual health. The primary objective was to evaluate the safety, tolerability, and efficacy of PEAK ATP, GlycoCarn, and PEAK ATP with GlycoCarn in improving blood sugar levels. Secondary objectives included assessment of their effects on flow‐mediated dilation; changes in blood levels of HbA1C, hs‐CRP, insulin, nitric oxide, malondialdehyde, s‐ICAM‐1, and E‐selectin; changes in body weight, BMI, percent body fat, waist and hip circumference, and blood pressure; and their effect on general and sexual health.

Methods

Each subject was randomized to participate in one of the four treatment cohorts for 90 days. A total of 67 subjects were enrolled, with study visits following enrollment occurring on Days 30, 60, and 90, at which time assessments, questionnaires, and laboratory testing were completed. Baseline values were compared with Days 30, 60, and 90 for all subjects who completed the clinical trial.

Results

A total of 53 subjects completed the trial (23 males and 30 females; 55.4±6.4 years; 67.2±4.1 in. [170.7±10.4 cm]; 199.4±36.4 lbs. [90.4±16.5 kg]). The Day 90 analysis showed a statistically significant mean decrease in blood glucose for PEAK ATP. PEAK ATP with GlycoCarn led to statistically significant mean decreases in body weight, BMI, waist and hip circumference, and waist/height ratio. GlycoCarn led to statistically significant mean increases in flow‐mediated dilation and statistically significant mean decreases in malondialdehyde and triglyceride levels. Peak ATP led to statistically significant mean increases in flow‐mediated dilation and statistically significant mean decreases in malondialdehyde levels, waist and hip circumference, and waist/height ratio. Changes in vital signs, body weight, and clinical laboratory parameters related to safety were minimal and within normal ranges. A mean decrease in ALT and pulse rate was seen in all four cohorts, with statistical significance noted in the PEAK ATP cohort. There were no statistically significant changes in scores attained from the questionnaires for general and sexual health.

Conclusion

The treatments demonstrated improvements in certain study parameters related to blood glucose and cardiovascular health, and the results are worthy of further studies being conducted with larger sample sizes. The study treatments were generally well tolerated.

Support or Funding Information

Sigma‐Tau Health Science, LLCTSI Health Sciences Inc. Supplement Formulators Inc.