Beneficial Effect of Cuban Policosanol on Blood Pressure and Serum Lipoproteins Accompanied with Lowered Glycated Hemoglobin and Enhanced High-Density Lipoprotein Functionalities in a Randomized, Placebo-Controlled, and Double-Blinded Trial with Healthy Japanese

Abstract

This study evaluated the efficacy and safety of 20 mg of Cuban policosanol in blood pressure (BP) and lipid/lipoprotein parameters of healthy Japanese subjects via a placebo-controlled, randomized, and double-blinded human trial. After 12 weeks of consumption, the policosanol group showed significantly lower BP, glycated hemoglobin (HbA1c), and blood urea nitrogen (BUN) levels. The policosanol group also showed lower aspartate aminotransferase (AST), alanine aminotransferase (ALT), and γ-glutamyl transferase (γ-GTP) levels at week 12 than those at week 0: A decrease of up to 9% (p < 0.05), 17% (p < 0.05), and 15% (p < 0.05) was observed, respectively. The policosanol group showed significantly higher HDL-C level and HDL-C/TC (%), approximately 9.5% (p < 0.001) and 7.2% (p = 0.003), respectively, than the placebo group and a difference in the point of time and group interaction (p < 0.001). In lipoprotein analysis, the policosanol group showed a decrease in oxidation and glycation extent in VLDL and LDL with an improvement of particle shape and morphology after 12 weeks. HDL from the policosanol group showed in vitro stronger antioxidant and in vivo anti-inflammatory abilities. In conclusion, 12 weeks of Cuban policosanolconsumption in Japanese subjects showed significant improvement in blood pressure, lipid profiles, hepatic functions, and HbA1c with enhancement of HDL functionalities.

Cuban Policosanol (Raydel®) Exerts Higher Antioxidant and Anti-Glycation Activities than Chinese Policosanol (BOC Sciences) in Reconstituted High-Density Lipoproteins: In Vivo Anti-Inflammatory Activities in Zebrafish and Its Embryos

“…In rHDL, PCL-1 exhibited higher antioxidant activity against cupric-ion-mediated LDL oxidation ( Figure 3 ) and anti-glycation activity against the fructation of HDL to protect apoA-I from proteolytic degradation than PCL-2 ( Figure 4 ). These findings align with our previous studies investigating the effects of consuming 20 mg/day of Cuban policosanol over 12 weeks on reducing glycated hemoglobin levels in Japanese participants [ 10 , 11 ]. Although it has not been fully elucidated, there might be an optimum ratio of long-chain aliphatic alcohols (LCAA), especially C28, C32, and C34, to exert potent antioxidant and anti-glycation activity.…”

“…The enhancements in HDL quantity and quality are linked to the improvement in blood pressure in spontaneous hypertensive rats and prehypertensive human subjects [ 8 , 9 ]. Furthermore, 12 weeks of Cuban policosanol 20 mg (Raydel ® ) consumption ameliorated liver damage; reduced glycated hemoglobin; improved renal function and blood pressure via enhanced antioxidant ability; increased particle size; and improved cholesterol efflux activity in HDL 2 and HDL 3 in a randomized, double-blinded, placebo-controlled clinical study with middle-aged Japanese subjects [ 10 , 11 ].…”

Combination Therapy of Cuban Policosanol (Raydel®, 20 mg) and Intensive Exercise for 12 Weeks Resulted in Improvements in Obesity, Hypertension, and Dyslipidemia without a Decrease in Serum Coenzyme Q10: Enhancement of Lipoproteins Quality and Antioxidant Functionality in Obese Participants

“…Interestingly, a lower dose of 10 mg of policosanol in the same study did not demonstrate a significant effect on blood pressure [ 20 ]. In a separate randomized trial spanning 12 weeks, normotensive Japanese participants experienced a reduction of −7.9 mmHg (−9.5% compared to the baseline) in SBP and −2.8 mmHg (−4.0% compared to the baseline) in DBP with policosanol intake [ 28 ]. Preceding these prior clinical investigations, we opted for a 20 mg dosage of policosanol in the current study, exploring policosanol effects in conjunction with exercise among obese patients.…”

“…In addition, no nutrient supplements were allowed for all participants during the 12 weeks, because that may affect body weight, hepatic functions, and renal functions. The rationale for the selection of 20 mg policosanol was based on our previous findings, which demonstrated the effectiveness of the 20 mg dosage for 12 weeks in lowering both SBP and DBP in Korean hypertensive subjects [ 20 ] and normotensive Japanese participants [ 28 ].…”

“…Following a brief period, the stained HDL fraction was blotted onto a Formvar carbon-coated 300 mesh copper grid and allowed to air-dry. The morphology of each lipoprotein was determined by TEM at 40,000× magnification, using EMIP-EX software, Version 07.13 (Hitachi, Tokyo, Japan), in accordance with a previously documented protocol [ 28 ].…”