Abstract

Abstract Objectives The overall objective was to determine the effects of the multi-nutrient dietary supplement Cardioflex, independent of diet or lifestyle changes, to reduce cardiovascular disease (CVD) risk factors in adults. Methods A 90-day, randomized, double-blind, parallel design clinical study was performed from February to June 2019. Participants received one serving (10 g) of Cardioflex or an isocaloric maltodextrin placebo daily. Blood pressure was measured using an automatic sphygmomanometer. A 1-min arterial test (accelerated plethysmography; APG) and a 5-min heart-rate-variability (HRV) test were conducted using a Meridian digital pulse wave analyzer. Serum concentrations of total cholesterol (TC), triglycerides (TG) and high-density lipoprotein (HDL) were measured using Vitros-350 chemistry analyzer. Analysis of covariance was used to compare the post treatment biomarkers of the two groups using IBM SPSS Statistics (v.25). Results A total of 67 participants (placebo = 33, Cardioflex = 34) with a mean age of 48.3 ± 8.8 years, completed the study. Cardioflex improved HRV (+5%; P = 0.04) compared to the placebo (−9%). Although both groups saw improvements in blood pressure, heart rate, APG age, body mass index, waist circumference, TC, low-density lipoprotein (LDL), and TG, there was no significant difference (P > 0.05) between groups. Interestingly, the placebo significantly (P = 0.04) lowered (−18.7%) TC compared to Cardioflex (−15%). Conclusions Cardioflex supplement may benefit HRV; a parameter associated with CVD. However, more research is needed to understand its effects on CVD. Also, our study also highlights the ‘placebo effect’ that can occur in parallel design clinical trials. Funding Sources Funding was provided by MITACs and Innotech Nutrition.

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