Effect of D iamel in patients with metabolic syndrome: A randomized double‐blind placebo‐controlled study (Diamel对代谢综合征患者的影响：一项随机双盲安慰剂对照研究)

Background The aim of the present study was to determine whether the administration of D iamel, marketed as a food supplement by C atalysis L aboratories ( M adrid, S pain) 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 W orld H ealth O rganization criteria for MS were included in the study. Participants were randomly assigned to receive either oral D iamel 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, D iamel 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 D iamel, 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 D iamel treatment, combined with lifestyle changes, was beneficial for IR and IS , and reduced serum UA levels in patients with MS .