title: Effect of Diamel in patients with metabolic syndrome: a randomized double-blind placebo-controlled study.
abstract: BACKGROUND
  The aim of the present study was to determine whether the administration of Diamel, marketed as a food supplement by Catalysis Laboratories (Madrid, Spain) could improve any of the components of metabolic syndrome (MS), as well as insulin resistance and sensitivity.
  
  
  METHODS
  In all, 100 patients with MS (19-70 years of age) who satisfied the World Health Organization criteria for MS were included in the study. Participants were randomly assigned to receive either oral Diamel or a placebo (while maintaining a diet appropriate to their weight and physical activity) at a dose of two capsules before each of the three main meals each day for 1 year. Anthropometric indices, blood pressure, fasting plasma glucose, lipid profile, insulin, creatinine, and uric acid (UA) were determined. Insulin resistance (IR) was assessed and three indirect indices were used to calculate insulin sensitivity (IS).
  
  
  RESULTS
  Compared with placebo, Diamel improved fasting insulin concentrations, IS, and IR and reduced UA concentrations from 6 months until the end of treatment (P < 0.05 for all). In addition, after 12 months treatment with Diamel, significant changes from baseline were seen for mean fasting insulin (P < 0.05), UA (P < 0.05), IR (P < 0.001), and IS (P < 0.001), whereas no such changes were seen in the placebo-treated group. Improvements were noted in body mass index, IR, and IS in both groups.
  
  
  CONCLUSIONS
  Long-term Diamel treatment, combined with lifestyle changes, was beneficial for IR and IS, and reduced serum UA levels in patients with MS.
authors.affiliation: National Institute of Endocrinology, Havana, Cuba. diabetes@infomed.sld.cu
authors.forename: Eduardo
authors.initials: E
authors.lastname: Cabrera-Rode
authors.forename: Neraldo
authors.initials: N
authors.lastname: Orlandi
authors.forename: Yaneysi
authors.initials: Y
authors.lastname: Padrón
authors.forename: Celeste
authors.initials: C
authors.lastname: Arranz
authors.forename: Raysa
authors.initials: R
authors.lastname: Olano
authors.forename: Mayra
authors.initials: M
authors.lastname: Machado
authors.forename: Arturo
authors.initials: A
authors.lastname: Hernández-Yero
authors.forename: Raúl
authors.initials: R
authors.lastname: Calderín
authors.forename: Emma
authors.initials: E
authors.lastname: Domínguez
mesh_terms: D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000378:metabolism; D015992:Body Mass Index; D019587:Dietary Supplements; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007328:Insulin / Q000097:blood; D007333:Insulin Resistance; D008297:Male; D024821:Metabolic Syndrome / Q000628:therapy*; D008875:Middle Aged; D015990:Placebo Effect; D014527:Uric Acid / Q000097:blood
chemical_list: D001786:Blood Glucose; D007328:Insulin; D014527:Uric Acid