title: Effects of a new combination of nutraceuticals with Morus alba on lipid profile, insulin sensitivity and endotelial function in dyslipidemic subjects. A cross-over, randomized, double-blind trial.
abstract: BACKGROUND
  Nutraceuticals (NUT) are forms of compounds with biological activity commonly used to improve health in dosage largely exceeding those obtainable in food.
  
  
  OBJECTIVE
  We compared, in a double blind randomized cross-over trial, the effects of two NUT combinations on the control of glico-lipidic metabolism in patients with hypercholesterolemia not on statins.
  
  
  METHODS
  At study start patients were given dietary counseling and received placebo for 2 weeks. After this run-in period, patients were randomized: (1) Combination A [Policosanol, Red yeast rice (Monakolin K 3 mg), Berberine 500 mg, Astaxantine, Folic Acid and Coenzyme Q10] for 4 weeks followed by 4 weeks of Combination B [Red yeast rice (Monakolin K 3.3 mg), Berberine 531.25 mg and leaf extract of Morus alba]; (2) Combination B for 4 weeks followed by 4 weeks of Combination A.
  
  
  RESULTS
  Combination B reduced LDL cholesterol below 130 mg/dl in 56.5 % of the patients, and Cambination A only in 21.7 % of them (p ≤ 0.027). Both treatments reduced plasma levels of triglycerides, total and LDL cholesterol and increased HDL cholesterol (all p < 0.03). Total and LDL cholesterol reduction was more pronounced in patients taking Combination B (p < 0.005). Combination B reduced also glycated hemoglobin, fasting glucose and insulin plasma levels as well as HOMA index (p < 0.005).
  
  
  CONCLUSIONS
  An increased content of Berberin and Monacolin K and the addition of Morus alba extract improves the effect on plasma cholesterol and on glucose metabolism of the NUT Combination. These effects may allow the speculation of a more marked improvement in cardiovascular prognosis.
authors: Department of Neurosciences, Federico II University, Naples, Italy.
authors: Valentina
authors: V
authors: Trimarco
authors: Raffaele
authors: R
authors: Izzo
authors: Eugenio
authors: E
authors: Stabile
authors: Francesco
authors: F
authors: Rozza
authors: Mario
authors: M
authors: Santoro
authors: Maria Virginia
authors: MV
authors: Manzi
authors: Federica
authors: F
authors: Serino
authors: Gabriele Giacomo
authors: GG
authors: Schiattarella
authors: Giovanni
authors: G
authors: Esposito
authors: Bruno
authors: B
authors: Trimarco
mesh_terms: D000368:Aged; D001599:Berberine / Q000627:therapeutic use; D015415:Biomarkers / Q000097:blood; D001786:Blood Glucose / Q000187:drug effects / Q000378:metabolism; D018592:Cross-Over Studies; D019587:Dietary Supplements / Q000009:adverse effects; D004311:Double-Blind Method; D050171:Dyslipidemias / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D004730:Endothelium, Vascular / Q000187:drug effects* / Q000503:physiopathology; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use; D000960:Hypolipidemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D007328:Insulin / Q000097:blood; D007333:Insulin Resistance; D007558:Italy; D008055:Lipids / Q000097:blood*; D008148:Lovastatin / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D031625:Morus; D010936:Plant Extracts / Q000009:adverse effects / Q000627:therapeutic use*; D018515:Plant Leaves; D013997:Time Factors; D016896:Treatment Outcome; D014664:Vasodilation / Q000187:drug effects*
chemical_list: D001599:Berberine; D015415:Biomarkers; D001786:Blood Glucose; D006442:Glycated Hemoglobin; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D000960:Hypolipidemic Agents; D007328:Insulin; D008055:Lipids; D008148:Lovastatin; D010936:Plant Extracts; C517652:hemoglobin A1c protein, human