Efficacy and Tolerability of a Food Supplement Based on L., (Retz.) R.br.ex Sm, Zinc and Chromium for the Maintenance of Normal Carbohydrate Metabolism: A Monocentric, Randomized, Double-Blind, Placebo-Controlled Clinical Trial.

Maria Vittoria Morone, Alessandro Di Minno, Roberto Piccinocchi, Hammad Ullah, Lorenza Francesca De Lellis, Alessandra Baldi, Daniele Giuseppe Buccato, Danaé S Larsen, Maria Daglia, Roberto Sacchi, Marcello Cordara, Agostino Greco, Salvatore Santonastaso

Journal: Nutrients 2024;16(15):

PMID: 39125340

Abstract

A study on 81 individuals (18-75 years old) with mildly impaired fasting blood glucose (FBG) concentrations (98-125 mg/dL) was undertaken to investigate the tolerability of a food supplement (FS) based on and extracts, zinc, and chromium and its efficacy on glucose and lipid metabolism. The subjects were randomized into three groups (27 in each group) and supplemented with one or two tablet(s)/day of FS (groups 1 and 2, respectively), or two tablets/day of placebo (group 3). Blood sampling was carried out at baseline (t0) and after a 3-month treatment (t1), and biochemical parameters associated with glucose and lipid metabolism and kidney and liver toxicity were evaluated. Compared to the placebo, FBG and glycated haemoglobin (HbA1c) were significantly ( < 0.001) reduced in group 1 subjects. In contrast, at the doses of one and two tablet(s)/day, the FS exerted no effect on the other parameters examined. We conclude that in subjects with slightly impaired FBG, ingestion of a FS based on and extracts, zinc, and chromium over 3 months lowers FBG and modulates glucose homeostasis by improving glucose metabolism. These beneficial effects occur in the absence of biochemical evidence of kidney and liver toxicity.

Address: Department of Pharmacy, University of Napoli Federico II, Via D. Montesano 49, 80131 Naples, Italy.; Department of Experimental Medicine, Section of Microbiology and Clinical Microbiology, University of Campania "L. Vanvitelli", 80138 Naples, Italy.; School of Chemical Sciences, The University of Auckland, Auckland 1010, New Zealand.; Department of Pharmacy, University of Napoli Federico II, Via D. Montesano 49, 80131 Naples, Italy.; CEINGE-Biotecnologie Avanzate, Via Gaetano Salvatore 486, 80145 Naples, Italy.; School of Medicine, University of Milano-Bicocca, 20126 Milan, Italy.; Level 1 Medical Director Anaesthesia and Resuscitation A. U. O. Luigi Vanvitelli, Via Santa Maria di Costantinopoli, 80138 Naples, Italy.; A.S.L. Caserta, Via P. Harris, 81100 Caserta, Italy.; Applied Statistic Unit, Department of Earth and Environmental Sciences, University of Pavia, Viale Taramelli 24, 27100 Pavia, Italy.; Department of Pharmacy, University of Napoli Federico II, Via D. Montesano 49, 80131 Naples, Italy.; International Research Center for Food Nutrition and Safety, Jiangsu University, Zhenjiang 212013, China.
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