Effects of Poly-Bioactive Compounds on Lipid Profile and Body Weight in a Moderately Hypercholesterolemic Population with Low Cardiovascular Disease Risk: A Multicenter Randomized Trial

Abstract

A dietary supplement (AP, Armolipid Plus) that combines red yeast rice extract, policosanol, berberine, folic acid, coenzyme Q10 and asthaxantine can have beneficial effects on cardiovascular disease (CVD) biomarkers. The aim of this study was to assess whether the intake of AP, in combination with dietary recommendations, reduces serum low density lipoprotein cholesterol (LDL-c) concentrations and other CVD biomarkers in patients with hypercholesterolemia. Eligible patients were recruited from the outpatient clinics of six Spanish hospitals Hospital Virgen del Rocío (Sevilla); Hospital San Jorge (Huesca); Hospital San Pedro (Logroño); Hospital Gregorio Marañón (Madrid), Hospital la Fe (Valencia) and Hospital Universitari Sant Joan (Reus) as recruiting and coordinating center. 102 participants (mean age ± SD; 50.91±11.61; 32 men) with low CVD, with mild-to-moderately elevated LDL-c (between 3.35 mmol/L and 4.88 mmol/L) without hypolipemic therapy were randomized in a double-blind, parallel, controlled, multicenter trial commencing January 2012 and ending December 2012. Among the exclusion criteria were any concomitant chronic disease, triglycerides (TG) >3.97 mmol/L, pregnant or lactating, and history of CVD. At 12 weeks, compared to placebo, AP reduced LDL-c by −6.9%, apolipoprotein (Apo) B-100 by −6.6% and total cholesterol/HDL-c ratio by −5.5%, the ApoB/ApoA1 ratio by −8.6%, while increasing ApoA1 by +2.5% (p<0.05). AP consumption was associated with modest mean weight loss of −0.93 kg (95%CI: -1.74 to -0.12; P = 0.02) compared with control group while dietary composition remained unchanged in the AP group. The AP product was well tolerated. In conclusion, AP, combined with dietary recommendations, reduced LDL-c levels as well as total cholesterol/HDL-c and ApoB/ApoA1 ratios, while increasing Apo A1, all of which are improvements in CVD risk indicators. AP is a product which could benefit patients having moderate hyperlipidemia and excess body weight.Trial RegistrationClinicalTrials.gov NCT01562080

Berberine and barberry (Berberis vulgaris): A clinical review

“…Armolipid Plus is a nutraceutical that contains berberine, policosanol, coenzyme Q10, fermented rice with red yeast, folic acid, and astaxanthin. It has been evaluated in some clinical trials and showed to be effective in the reduction of LDL‐C levels (Marazzi et al, ; Ruscica et al, ; Solà et al, ).…”

The role of mast cells in functional GI disorders

“…Natural flavonoids (fisetin, kaempferol, quercetin, rutin, luteolin) and the active alkaloid berberine inhibit the mediator release of MCs in vitro115 and protect intestinal epithelial barrier 114. While some of these products have been shown to be useful in cardiovascular health117 and cancer,118 their clinical efficacy in FGIDs has not been established. There is some evidence of symptomatic response to specific diets in FGIDs, such as low FODMAP and gluten-depleted food 20.…”

Effects of Armolipid Plus on small dense LDL particles in a sample of patients affected by familial combined hyperlipidemia

“…Solà et al [21] in a randomized, double-blind, parallel, placebo-controlled multicenter trial showed that in 102 patients with low CV risk at 12 weeks, Armolipid Plus reduced LDL, apo B-100 and total cholesterol/HDL ratio, the Apo B/apo A-I ratio, while increasing apo A-I. Armolipid Plus was also associated with modest mean weight loss compared with control group, while dietary composition remained unchanged in the Armolipid Plus group [21].…”

“…Armolipid Plus was also associated with modest mean weight loss compared with control group, while dietary composition remained unchanged in the Armolipid Plus group [21]. …”