A Healthy Balance of Plasma Cholesterol by a Novel Annurca Apple-Based Nutraceutical Formulation: Results of a Randomized Trial

Journal of Medicinal Food

Volumn 20, Issue 3, 2017, Pages 288-300

  Tenore, Gian Carlo ^a   Caruso, Domenico ^b   Buonomo, Giuseppe ^c   D'Avino, Maria ^b   Campiglia, Pietro ^d   Marinelli, Luciana ^a   Novellino, Ettore ^a  

^a UNIVERSITY OF NAPLES FEDERICO II   (Italy)

^b CARDARELLI HOSPITAL   (Italy)

^c Coop Samnium Medica ^*  (Italy)

^d UNIVERSITY OF SALERNO   (Italy)

Author keywords

Annurca apple; Nutraceutical; Plasma cholesterol; Polyphenols; Randomized controlled clinical trial

Indexed keywords

ATORVASTATIN; CHOLESTEROL; HIGH DENSITY LIPOPROTEIN; LOW DENSITY LIPOPROTEIN CHOLESTEROL; NUTRACEUTICAL; POLYPHENOL DERIVATIVE; SIMVASTATIN; ANTILIPEMIC AGENT; PLANT EXTRACT;

ADULT; AGED; ARTICLE; ATHEROSCLEROTIC PLAQUE; CHOLESTEROL BLOOD LEVEL; DOUBLE BLIND PROCEDURE; DRUG FORMULATION; DRUG SYNTHESIS; FEMALE; HUMAN; HYPERCHOLESTEROLEMIA; MAJOR CLINICAL STUDY; MALE; MALUS PUMILA; MICROCAPSULE; PRIMARY PREVENTION; PRIORITY JOURNAL; ADOLESCENT; ANALYSIS; BLOOD; CARDIOVASCULAR DISEASES; CHEMISTRY; CONTROLLED STUDY; DIETARY SUPPLEMENT; ISOLATION AND PURIFICATION; MALUS; MIDDLE AGED; RANDOMIZED CONTROLLED TRIAL; VERY ELDERLY; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; CARDIOVASCULAR DISEASES; CHOLESTEROL; DIETARY SUPPLEMENTS; FEMALE; HUMANS; HYPOLIPIDEMIC AGENTS; MALE; MALUS; MIDDLE AGED; PLANT EXTRACTS; YOUNG ADULT;

EID: 85015616843     PISSN: 1096620X     EISSN: 15577600     Source Type: Journal    
DOI: 10.1089/jmf.2016.0152     Document Type: Article

References (32)

1. Rosenson RS, Brewer HB, Rader DJ: Lipoproteins as biomarkers and therapeutic targets in the setting of acute coronary syndrome. Circ Res 2014;114:1880-1889.
2. Lusis AJ: Atherosclerosis. Nature 2000;407:233-241.
3. Hansson GK: Inflammation, atherosclerosis, and coronary artery disease. N Engl J Med 2005;352:1685-1695.
4. Gaut JP, Heinecke JW: Mechanisms for oxidizing low-density lipoprotein: Insights from patterns of oxidation products in the artery wall and from mouse models of atherosclerosis. Trends Cardiovasc Med 2001;11:103-112.
5. von Eckardstein A, Nofer JR, Assmann G: High density lipoproteins and arteriosclerosis: Role of cholesterol efflux and reverse cholesterol transport. Arterioscler Thromb Vasc Biol 2001;21: 13-27.
6. Chapman MJ, Assmann G, Fruchart JC, Shepherd J, Sirtori C: Raising high-density lipoprotein cholesterol with reduction of cardiovascular risk: The role of nicotinic acid-a position paper developed by the European Consensus Panel on HDL-C. Curr Med Res Opin 2004;20:1253-1268.
7. Rosenson RS, Brewer HB Jr, Ansell B, et al.: Translation of highdensity lipoprotein function into clinical practice: Current prospects and future challenges. Circulation 2013;128:1256-1267.
8. Assmann G, Nofer JR: Atheroprotective effects of high-density lipoproteins. Annu Rev Med 2003;54:321-341.
9. Alonso-Salces RM, Ndjoko K, Queiroz EF, et al.: On-line characterisation of apple polyphenols by liquid chromatography coupled with mass spectrometry and ultraviolet absorbance detection. J Chromatogr A 2004;1046:89-100.
10. Tenore GC, Campiglia P, Stiuso P, Ritieni A, Novellino E: Nutraceutical potential of polyphenolic fractions from Annurca apple (M. pumila Miller cv Annurca). Food Chem 2013;140:614-622.
11. Leifert WR, Abeywardena MY: Grape seed and red wine polyphenol extracts inhibit cellular cholesterol uptake, cell proliferation, and 5-lipoxygenase activity. Nutr Res 2008;28:842-850.
12. Nagasako-Akazome Y, Kanda T, Ikeda M, Shimasaki H: Serum cholesterol-lowering effect of apple polyphenols in healthy subjects. J Oleo Sci 2005;54:143-151.
13. Tenore GC, Caruso D, Buonomo G, et al.: Annurca (Malus pumilaMiller cv. Annurca) apple as a functional food for the contribution to a healthy balance of plasma cholesterol levels: Results of a randomized clinical trial. J Sci Food Agric 2016; [Epub ahead of print], doi: 10.1002/jsfa.8016.
14. Tenore GC, Campiglia P, Ritieni A, Novellino E: In vitro bioaccessibility, bioavailability and plasma protein interaction of polyphenols from Annurca apple (M. pumila Miller cv Annurca). Food Chem 2013;141:3519-3524.
15. Gali HU, Perchellet EM, Gao XM, Karchesy JJ, Perchellet JP: Comparison of the inhibitory effects of monomeric, dimeric, and trimeric procyanidins on the biochemical markers of skin tumor promotion in mouse epidermis in vivo. Planta Med 1994;60:235-239.
16. Lotito SB, Actis-Goretta L, Renart ML, Caligiuri M, Rein D, Schmitz HH., et al.: Influence of oligomer chain length on the antioxidant activity of procyanidins. Biochem Biophys Res Commun 2000;276:945-951.
17. Sakano K, Mizutani M, Murata M, Oikawa S, Hiraku Y, Kawanishi S: Procyanidin B2 has anti-and pro-oxidant effects on metal-mediated DNA damage. Free Radic Biol Med 2005;39: 1041-1049.
18. Lo Scalzo R, Testoni A, Genna A: ''Annurca'' apple fruit, a southern Italy apple cultivar: Textural properties and aroma composition. Food Chem 2001;73:333-343.
19. Little RJ, Rubin DB: Statistical Analysis with Missing Data. Hoboken, NJ: John Wiley & Sons, 2002.
20. Molenberghs G, Thijs H, Jansen I, et al.: Analyzing incomplete longitudinal clinical trial data. Biostatistics 2004;5:445-464.
21. O'Kelly M, Ratitch B: Clinical Trials with Missing Data: A Guide for Practitioners. Hoboken, NJ: John Wiley & Sons, 2014.
22. White IR, Carpenter J, Horton NJ: Including all individuals is not enough: Lessons for intention-to-treat analysis. Clin Trials 2012; 9: 396-407.
23. Carpenter JR, Kenward MG: Missing data in randomised controlled trials-a practical guide. National Institute for Health Research. Publication RM03/JH17/MK, http://missingdata.lshtm .ac.uk downloads/rm04-jh17-mk.pdf. 2007. (accessed October 6, 2016).
24. Calvert M, Blazeby J, Altman DG, Revicki DA, Moher D, Brundage MD: CONSORT PRO Group. Reporting of patientreported outcomes in randomized trials: The CONSORT PRO extension. JAMA 2013;309: 814-822.
25. Millán J, Pintó X, Munõz A, et al.: Lipoprotein ratios: Physiological significance and clinical usefulness in cardiovascular prevention. Vasc Health Risk Manag 2009;5:757-765.
26. Gormley TR, Kevany J, Egan JP, McFarlane R: Effect of apples on serum cholesterol levels in humans. Irish J Food Sci Technol 1977;1:117-128.
27. Sable-Amplis R, Sicart R, Agid R: Further studies on the cholesterol-lowering effect of apple in human. Biochemical mechanims involved. Nutr Res 1983;3:325-328.
28. Ravn-Haren G, Dragsted LO, Buch-Andersen T, Jensen EN, Jensen RI, Németh-Balogh M, et al.: Intake of whole apples or clear apple juice has contrasting effects on plasma lipids in healthy volunteers. Eur J Nutr 2013;52:1875-1889.
29. Hyson D, Studebaker-Hallman D, Davis PA, Gershwin ME: Apple juice consumption reduces plasma low-density lipoprotein oxidation in healthy men and women. J Med Food 2009;159-166.
30. LawMR,WaldNJ, RudnickaAR:Quantifying effect of statins on low density lipoprotein cholesterol, ischaemic heart disease, and stroke: Systematic review and meta-analysis. Brit Med J 2003;326:1423.
31. Rossebo AB, Boman K, Brudi P, et al.: Intensive lipid lowering with simvastatin and ezetimibe in aortic stenosis. N Engl J Med 2008;359:1343-1356.
32. Dekker MJ, Su Q, Baker C, Rutledge AC, Adeli K: Fructose: A highly lipogenic nutrient implicated in insulin resistance, hepatic steatosis, and the metabolic syndrome. Am J Physiol Endocrinol Metab 2010;299:685-694.