A Unique Formulation of Cardioprotective Bio-Actives: An Overview of Their Safety Profile.

The burden of cardiovascular disease (CVD) remains high globally and in the United States despite the availability of pharmaceuticals aimed at its prevention and treatment. An invention by Summit Innovation Labs, which is a formula consisting of a unique blend of select polyphenols (i.e., curcumin, quercetin, resveratrol), vitamin K2 as menaquinone-7, and magnesium, was recently developed to modulate the impact of the specific drivers of CVD, namely, vascular calcification, oxidative stress, and chronic inflammation. The SIL formulation is a dietary supplement that was designed leveraging the more bioavailable forms of ingredients with poor absorption, such as curcumin and quercetin. Each ingredient within the SIL formulation has been shown to contribute to CVD risk reduction by moderating the effect of CVD triggers, thereby providing a holistic prevention strategy for CVD in the healthy population. This review focuses on recently published clinical data to support the safety profile of these ingredients following oral administration. The preponderance of clinical trial data reviewed support the overall safety of the bioactives when used singly or in combination. The most commonly reported adverse effects were generally mild dose-related gastrointestinal disturbances, which may be alleviated with diet in some cases. In light of these, we conclude that the combination of the ingredients in the SIL formulation is reasonably expected to be safe.