RT Journal Article T1 Effects of sardine-enriched diet on metabolic control, inflammation and gut microbiota in drug-naïve patients with type 2 diabetes: a pilot randomized trial. A1 Balfegó, Mariona A1 Canivell, Silvia A1 Hanzu, Felicia A A1 Sala-Vila, Aleix A1 Martínez-Medina, Margarita A1 Murillo, Serafín A1 Mur, Teresa A1 Ruano, Elena G A1 Linares, Francisca A1 Porras, Nuria A1 Valladares, Silvia A1 Fontalba, Maria A1 Roura, Elena A1 Novials, Anna A1 Hernández, Cristina A1 Aranda, Gloria A1 Sisó-Almirall, Antoni A1 Rojo-Martínez, Gemma A1 Simó, Rafael A1 Gomis, Ramon K1 Type 2 diabete K1 Pilot trial K1 Nutrition therapy K1 Oily fish K1 Sardine K1 Adiponectina K1 Grupos control K1 Diabetes mellitus tipo II K1 Dieta K1 Membrana eritrocítica K1 Escherichia coli K1 Ayuno K1 Ácidos grasos omega 3 K1 Firmicutes K1 Microbiota intestinal K1 Glucosa K1 Hemoglobina A glicosilada K1 Homeostasis K1 Humanos K1 Insulina K1 Resistencia a la insulina K1 Política nutricional K1 Terapia nutricional K1 Proyectos piloto K1 Prevotella K1 Factores de riesgo K1 Bacteroides K1 Bacteroidetes K1 Glucosa sanguínea K1 Enfermedades cardiovasculares K1 Animales AB BACKGROUNDNutrition therapy is the cornerstone of treating diabetes mellitus. The inclusion of fish (particularly oily fish) at least two times per week is recommended by current international dietary guidelines for type 2 diabetes. In contrast to a large number of human studies examining the effects of oily fish on different cardiovascular risk factors, little research on this topic is available in patients with type 2 diabetes. The aims of this pilot study were to investigate the effects of a sardine-enriched diet on metabolic control, adiponectin, inflammatory markers, erythrocyte membrane fatty acid (EMFA) composition, and gut microbiota in drug-naïve patients with type 2 diabetes.METHODS35 drug-naïve patients with type 2 diabetes were randomized to follow either a type 2 diabetes standard diet (control group: CG), or a standard diet enriched with 100 g of sardines 5 days a week (sardine group: SG) for 6 months. Anthropometric, dietary information, fasting glycated hemoglobin, glucose, insulin, adiponectin, inflammatory markers, EMFA and specific bacterial strains were determined before and after intervention.RESULTSThere were no significant differences in glycemic control between groups at the end of the study. Both groups decreased plasma insulin (SG: -35.3%, P = 0.01, CG: -22.6%, P = 0.02) and homeostasis model of assessment--insulin resistance (HOMA-IR) (SG: -39.2%, P = 0.007, CG: -21.8%, P = 0.04) at 6-months from baseline. However only SG increased adiponectin in plasma compared to baseline level (+40.7%, P = 0.04). The omega-3 index increased 2.6% in the SG compared to 0.6% in the CG (P = 0.001). Both dietary interventions decreased phylum Firmicutes (SG and CG: P = 0.04) and increased E. coli concentrations (SG: P = 0.01, CG: P = 0.03) at the end of the study from baseline, whereas SG decreased Firmicutes/Bacteroidetes ratio (P = 0.04) and increased Bacteroides-Prevotella (P = 0.004) compared to baseline.CONCLUSIONSAlthough enriching diet with 100 g of sardines 5 days a week during 6 months to a type 2 diabetes standard diet seems to have neutral effects on glycemic control in drug-naïve patients with type 2 diabetes, this nutritional intervention could have beneficial effects on cardiovascular risk. Furthermore, both dietary interventions decreased HOMA-IR and altered gut microbiota composition of drug-naïve patients with type 2 diabetes.TRIAL REGISTRATIONTrial number and name of the registry: NCT02294526, ClinicalTrials.gov. PB Public Libray of Science YR 2016 FD 2016-04-18 LK http://hdl.handle.net/10668/2405 UL http://hdl.handle.net/10668/2405 LA en NO Balfegó M, Canivell S, Hanzu FA, Sala-Vila A, Martínez-Medina M, Murillo S, et al. Effects of sardine-enriched diet on metabolic control, inflammation and gut microbiota in drug-naïve patients with type 2 diabetes: a pilot randomized trial. Lipids Health Dis. 2016; 15:78 NO Journal Article; Research Support, Non-U.S. Gov't; Trial number and name of the registry: NCT02294526, ClinicalTrials.gov. DS RISalud RD Apr 18, 2025