title: Short-term effects of a combined nutraceutical of insulin-sensitivity, lipid level and indexes of liver steatosis: a double-blind, randomized, cross-over clinical trial.
abstract: BACKGROUND
  Overweight subjects easily develop alterations of the glucose and lipid metabolism and are exposed to an increased cardiometabolic risk. This condition is potentially reversible through the improvement of dietary and behavioural habits. However, a well-assembled nutraceutical would be a useful tool to better improve the metabolic parameters associated to overweight and insulin resistance.
  
  
  METHODS
  To evaluate the effect of a combined nutraceutical containing berberine, chlorogenic acid and tocotrienols, we performed a double blind, cross-over designed trial versus placebo, in 40 overweight subjects with mixed hyperlipidaemia. After the first 8 weeks of treatment (or placebo), patients were asked to observe a 2-week washout period, and they were then assigned to the alternative treatment for a further period of 8 weeks. Clinical and laboratory data associated to hyperlipidaemia and insulin resistance have been obtained at the baseline, at the end of the first treatment period, after the washout, and again after the second treatment period.
  
  
  RESULTS
  Both groups experienced a significant improvement of anthropometric and biochemical parameters versus baseline. However, total cholesterol, LDL cholesterol, triglycerides, non-HDL cholesterol, fasting insulin, HOMA-IR, GOT and Lipid Accumulation Product decreased more significantly in the nutraceutical group versus placebo.
  
  
  CONCLUSIONS
  This combination seems to improve a large number of metabolic and liver parameters on the short-term in overweight subjects. Further studies are needed to confirm these observations on the middle- and long-term.
authors.affiliation: Department of Medicine and Surgery Sciences, University of Bologna, Bologna, Italy. afgcicero@cardionet.it.|Hypertension Research Center, Poliambulatorio Pad. 2, Via Albertoni, 15, 40138, Bologna, Italy. afgcicero@cardionet.it.
authors.forename: Arrigo F G
authors.initials: AF
authors.lastname: Cicero
authors.affiliation: Department of Medicine and Surgery Sciences, University of Bologna, Bologna, Italy. mrosticci@yahoo.com.
authors.forename: Martina
authors.initials: M
authors.lastname: Rosticci
authors.affiliation: Department of Medicine and Surgery Sciences, University of Bologna, Bologna, Italy. angeloparini.ap@gmail.com.
authors.forename: Angelo
authors.initials: A
authors.lastname: Parini
authors.affiliation: Department of Medicine and Surgery Sciences, University of Bologna, Bologna, Italy. martino.morbini@gmail.com.
authors.forename: Martino
authors.initials: M
authors.lastname: Morbini
authors.affiliation: Department of Medicine and Surgery Sciences, University of Bologna, Bologna, Italy. ursoriccardo@gmail.com.
authors.forename: Riccardo
authors.initials: R
authors.lastname: Urso
authors.affiliation: Department of Medicine and Surgery Sciences, University of Bologna, Bologna, Italy. elisa.grandi@unibo.it.
authors.forename: Elisa
authors.initials: E
authors.lastname: Grandi
authors.affiliation: Department of Medicine and Surgery Sciences, University of Bologna, Bologna, Italy. claudio.borghi@unibo.it.
authors.forename: Claudio
authors.initials: C
authors.lastname: Borghi
mesh_terms: D000328:Adult; D000368:Aged; D001599:Berberine / Q000097:blood / Q000494:pharmacology; D002726:Chlorogenic Acid / Q000097:blood / Q000494:pharmacology; D018592:Cross-Over Studies; D019587:Dietary Supplements; D004311:Double-Blind Method; D005234:Fatty Liver / Q000097:blood* / Q000150:complications / Q000188:drug therapy*; D005260:Female; D006801:Humans; D006949:Hyperlipidemias / Q000097:blood / Q000150:complications / Q000188:drug therapy; D007328:Insulin / Q000097:blood*; D007333:Insulin Resistance; D008055:Lipids / Q000097:blood*; D008297:Male; D008875:Middle Aged; D013995:Time; D024508:Tocotrienols / Q000097:blood / Q000494:pharmacology; D016896:Treatment Outcome
chemical_list: D007328:Insulin; D008055:Lipids; D024508:Tocotrienols; D001599:Berberine; D002726:Chlorogenic Acid