EFFECTS OF SUPPLEMENTS CONTAINING CURCUMIN, OMEGA FATTY ACIDS, GAMMA LINOLENIC ACID, VITAMIN E, VITAMIN D, HYDROXYTYROSOL, AND ASTAXANTHIN ON CARDIOVASCULAR HEALTH: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL TRIAL

Abstract

Therapeutic Area: ASCVD /CVD Risk Reduction Background: Over half of the US adults use Dietary supplements to improve their general health and prevent cardiovascular disease. We aimed to evaluate the effects of the above mentioned supplements on endothelial function, inflammation and cardiovascular risks over 90 days. Methods: A single-center, prospective, double-blinded, randomized, placebo-controlled (1:1 ratio) clinical trial was performed at the Lundquist institute at harbor-UCLA medical center. 53 asymptomatic volunteers aged ≥18 years, with SBP >120 or DBP >80 mmHg were enrolled. Each participant received 6 capsules daily for 90 days. The primary endpoint was changes from baseline in inflammatory markers including hypersensitive C - reactive protein (hsCRP), interleukin 6 (IL6) and Tumor Necrosis Factor Alpha (TNF-α), urine creatinine and F2-Isoprostane after 90 days. The secondary endpoint was change in endothelial function measured by Flow Mediated Dilatation (FMD) of brachial artery, Cardio-Ankle vascular index (CAVI) and blood pressure. Tertiary endpoint was changes from baseline in cholesterol, lipoprotein fractions (LDL and HDL), Triglycerides, and Omega fatty acids index. The final endpoint was supplement's safety. Results: 53 participants were randomized. 52 completed the trial with 26 in each group. The average age was 44.3±16.4 years and 52% were females. Both groups had similar demographics and risk factors, p>0.20.After taking the supplements for 90 days, the active group showed a significant increase in Omega-3 EPA, Omega-3 DPA and total Omega-3 levels, beside decrease in Omega-6 level, all P<0.05. A significant decrease in urine creatinine and F2-Isoprostane was also noticed, P<0.05. FMD increased with average of 0.5 + 2.8 in the active group compared to 0.2 + 2.2 in placebo group, P=0.66. CAVI decreased with average of 0.54 +1.52 in the active group compared to 0.09+1.31 in placebo group, P=0.26. Figure 1. No significant treatment effects on blood pressure, TNF-α, hsCRP, IL6, total cholesterol, Triglycerides, LDL, HDL, Arachidonic or Linoleic Acids. No Adverse events related to the supplements were reported. Conclusion: Treatment benefits of Curcumin, Omega fatty acids, gamma linolenic acid, vitamins, and astaxanthin supplements included robust increase in Omega-3 fatty acid levels and directional improvement in endothelial function. Longer follow up is warranted to evaluate the full potential of this treatment.