Bibliographic References and Clinical Sources
The formulation of Lipidaloe Plus was developed to support the physiological metabolism of plasma lipids, contribute to protection against oxidative stress, and promote the maintenance of cardiovascular function as part of a healthy lifestyle.
The bibliography provided includes systematic reviews, randomized clinical trials, meta-analyses, and EFSA documents relating to the individual ingredients in the formulation.
Bergamot Juice (Citrus bergamia Risso & Poit.)
Bergamot is one of the richest natural sources of flavonoids (neoeriocitrin, naringin, neohesperidin, hesperidin, and melitidin), molecules studied for their role in lipid metabolism, endothelial function, and oxidative protection.
Key clinical studies
• Mollace V, Sacco I, Janda E, et al. Hypolipemic and hypoglycaemic activity of bergamot polyphenols: from animal models to human studies. Fitoterapia. 2011;82(3):309-316.
A clinical study that showed significant reductions in total cholesterol and LDL, triglycerides, and an improvement in the antioxidant profile.
• Gliozzi M, Walker R, Musolino V, et al. Bergamot polyphenolic fraction enhances rosuvastatin-induced effect on LDL cholesterol, LOX-1 expression and oxidative stress. Frontiers in Pharmacology. 2013.
• Gliozzi M, Musolino V, Bosco F, et al. Bergamot polyphenols and cardiovascular risk. Frontiers in Pharmacology. 2021.
An updated review of the molecular mechanisms and cardiometabolic effects of bergamot flavonoids.
• Mollace V, Scicchitano M, Paone S, et al. Hypoglycemic and hypolipemic properties of Citrus bergamia. Phytotherapy Research. 2019.
• Toth PP, Patti AM, Nikolic D, et al. Bergamot reduces plasma lipids and improves lipoprotein profile. Lipids in Health and Disease. 2016.
The evidence shows improvements in the lipid profile, reduced LDL oxidation, improved endothelial function, and decreased inflammatory markers.
Fermented Red Rice (Monascus purpureus)
The monacolins found in fermented red rice are among the most studied nutraceutical substances for controlling LDL cholesterol.
Clinical studies
• Heber D, Yip I, Ashley JM, et al. Cholesterol-lowering effects of a proprietary Chinese red yeast rice dietary supplement. American Journal of Clinical Nutrition. 1999.
• Becker DJ, Gordon RY, Halbert SC, et al. Red yeast rice for dyslipidemia in statin-intolerant patients. Annals of Internal Medicine. 2009.
• Gerards MC, Terlou RJ, Yu H, et al. Traditional Chinese lipid-lowering agent red yeast rice results in significant LDL reduction. Nutrition Reviews. 2015.
• Fogacci F, Banach M, Mikhailidis DP, et al. Safety of red yeast rice supplementation: systematic review and meta-analysis. Archives of Medical Science. 2019.
• Banach M, Patti AM, Giglio RV, et al. The role of nutraceuticals in statin intolerant patients. Progress in Cardiovascular Diseases. 2018.
Meta-analyses confirm clinically significant reductions in LDL cholesterol and total cholesterol in subjects with mild-to-moderate hypercholesterolemia.
Vitamin C
Vitamin C physiologically contributes to the protection of cells against oxidative stress, normal immune function, and the maintenance of vascular function by supporting collagen synthesis.
Key references
• Carr AC, Maggini S. Vitamin C and Immune Function. Nutrients. 2017.
• Lykkesfeldt J, Michels AJ, Frei B. Vitamin C. Advances in Nutrition. 2014.
• Mason SA, et al. Effects of vitamin C supplementation on endothelial function. Atherosclerosis. 2014.
• Ellulu MS, Rahmat A, Patimah I, et al. Effect of vitamin C on inflammation and metabolic markers. Nutrients. 2015.
Vitamin E
Vitamin E is the main fat-soluble antioxidant in cell membranes and plasma lipoproteins.
Key studies
• Traber MG, Atkinson J. Vitamin E, antioxidant and nothing more. Free Radical Biology & Medicine. 2007.
• Brigelius-Flohé R, Traber MG. Vitamin E: function and metabolism. FASEB Journal. 1999.
• Niki E. Role of Vitamin E as a lipid-soluble peroxyl radical scavenger. Free Radical Biology & Medicine. 2014.
Studies on the synergy of the formulation
The combination of bergamot polyphenols, monacolins from fermented red rice, and antioxidant vitamins is consistent with modern nutraceutical strategies aimed at controlling cardiovascular risk.
Scientific reviews
• Cicero AFG, Colletti A. Nutraceuticals and cholesterol lowering. International Journal of Molecular Sciences. 2021.
• Banach M, Penson PE, Fras Z, et al. Brief recommendations on the management of dyslipidemia using nutraceuticals. Journal of Cachexia, Sarcopenia and Muscle. 2022.
• ESC/EAS Guidelines for the Management of Dyslipidaemias. European Heart Journal. 2021.
• Visseren FLJ et al. 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice. European Heart Journal. 2021.
Evidence on biological mechanisms
Available research indicates that the formulation works through complementary mechanisms:
• reduction of hepatic cholesterol synthesis by inhibiting HMG-CoA reductase (monacolins);
• improvement of endothelial function mediated by increased nitric oxide bioavailability (bergamot);
• reduction of LDL oxidation and oxidative stress (bergamot, vitamin C, and vitamin E);
• decrease in inflammatory biomarkers related to cardiovascular risk;
• protection of cell membranes and lipoproteins from lipid oxidation;
• support of normal immune function and vascular collagen metabolism thanks to vitamin C.
EFSA References and Institutional Sources
• EFSA NDA Panel. Scientific Opinion on the substantiation of health claims related to Monacolin K from red yeast rice and maintenance of normal blood LDL cholesterol concentrations. EFSA Journal. 2011.
• EFSA NDA Panel. Scientific Opinion on Vitamin C health claims. EFSA Journal.
• EFSA NDA Panel. Scientific Opinion on Vitamin E health claims. EFSA Journal.
• Regulation (EU) No 432/2012 establishing a list of permitted health claims on food products.
• Regulation (EC) No 1924/2006 on nutrition and health claims made on foods.
• Directive 2002/46/EC on food supplements.
• Regulation (EU) No 1169/2011 on the provision of food information to consumers.
Summary of evidence
The body of the most recent scientific literature supports the rationale for the Lipidaloe Plus formulation as nutritional support for individuals with lipid metabolism disorders, increased oxidative stress, and cardiovascular risk factors.
The strongest evidence concerns fermented red rice for reducing LDL cholesterol, while bergamot polyphenols show beneficial effects on the lipid profile, endothelial function, inflammation, and lipoprotein oxidation.
The presence of vitamin C and vitamin E completes the formulation, contributing to the protection of cells against oxidative stress through claims authorized by the European Union and supported by extensive clinical literature.