eng Science and Education Publishing Journal of Food and Nutrition Research 2333-1240 2023-04-26 11 4 319 324 10.12691/jfnr-11-4-6 JFNR20231146 article Giuseppe Derosa giuseppe.derosa@unipv.it 1 2 3 Angela DĄŻAngelo 3 3 Pamela Maffioli 3 3 Centre of Diabetes and Metabolic Diseases, Department of Internal Medicine and Therapeutics, University of Pavia and Fondazione IRCCS Policlinico San Matteo, PAVIA, Italy The primary endpoint of the current study was to evaluate whether the effects previously demonstrated in the 3-month study could be maintained for 12 months. Patients were randomized to take Glicoset® in addition to a standardized diet, or to follow a standardized diet alone for 12 months. Glicoset® was self-administered once a day, 1 tablet during the breakfast. After 12 months, 31.9 % of patients retuned to a normal glycemic status in the group treated with nutraceutical + diet vs 3.3 % of patients in diet alone group (p < 0.05). At the end of the study 43.6% were classified as IFG in the group treated with nutraceutical + diet group vs 37% in diet alone group (p < 0.05). In the group treated with nutraceutical + diet, 24.5% were classified as IGT at the end of the study vs 51.1% in diet alone group (p < 0.01). In diet alone group, 8.7% developed type 2 diabetes mellitus vs 0 patients in diet + nutraceutical group (p < 0.05). Total cholesterol, LDL-C, and Tg were lower in the group treated with the nutraceutical combination. The positive effects on glycemic and lipid profile already showed in a 3 months study were also maintained after 12 months of treatment with a nutraceutical containing Ilex Paraguariensis, White Mulberry and Chromium Picolinate. http://pubs.sciepub.com/jfnr/11/4/6/jfnr-11-4-6.pdf Ilex Paraguariensis White Mulberry Chromium Picolinate