Balfegó, MarionaCanivell, SilviaHanzu, Felicia ASala-Vila, AleixMartínez-Medina, MargaritaMurillo, SerafínMur, TeresaRuano, Elena GLinares, FranciscaPorras, NuriaValladares, SilviaFontalba, MariaRoura, ElenaNovials, AnnaHernández, CristinaAranda, GloriaSisó-Almirall, AntoniRojo-Martínez, GemmaSimó, RafaelGomis, Ramon2016-09-072016-09-072016-04-18Balfegó 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; 15:78http://hdl.handle.net/10668/2405Journal Article; Research Support, Non-U.S. Gov't; Trial number and name of the registry: NCT02294526, ClinicalTrials.gov.BACKGROUND Nutrition 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. METHODS 35 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. RESULTS There 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. CONCLUSIONS Although 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 REGISTRATION Trial number and name of the registry: NCT02294526, ClinicalTrials.gov.enType 2 diabetePilot trialNutrition therapyOily fishSardineAdiponectinaGrupos controlDiabetes mellitus tipo IIDietaMembrana eritrocíticaEscherichia coliAyunoÁcidos grasos omega 3FirmicutesMicrobiota intestinalGlucosaHemoglobina A glicosiladaHomeostasisHumanosInsulinaResistencia a la insulinaPolítica nutricionalTerapia nutricionalProyectos pilotoPrevotellaFactores de riesgoBacteroidesBacteroidetesGlucosa sanguíneaEnfermedades cardiovascularesAnimalesMedical Subject Headings::Chemicals and Drugs::Hormones, Hormone Substitutes, and Hormone Antagonists::Hormones::Peptide Hormones::Adipokines::AdiponectinMedical Subject Headings::Organisms::Eukaryota::AnimalsMedical Subject Headings::Organisms::Bacteria::Bacteroidetes::Bacteroidaceae::BacteroidesMedical Subject Headings::Organisms::Bacteria::BacteroidetesMedical Subject Headings::Chemicals and Drugs::Carbohydrates::Monosaccharides::Hexoses::Glucose::Blood GlucoseMedical Subject Headings::Diseases::Cardiovascular DiseasesMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Methods::Research Design::Control GroupsMedical Subject Headings::Diseases::Endocrine System Diseases::Diabetes Mellitus::Diabetes Mellitus, Type 2Medical Subject Headings::Phenomena and Processes::Physiological Phenomena::Nutritional Physiological Phenomena::DietMedical Subject Headings::Anatomy::Hemic and Immune Systems::Blood::Blood Cells::Erythrocytes::Erythrocyte MembraneMedical Subject Headings::Organisms::Bacteria::Proteobacteria::Gammaproteobacteria::Enterobacteriaceae::Escherichia::Escherichia coliMedical Subject Headings::Phenomena and Processes::Physiological Phenomena::Nutritional Physiological Phenomena::Diet::FastingMedical Subject Headings::Chemicals and Drugs::Lipids::Fatty Acids::Fatty Acids, Unsaturated::Fatty Acids, Omega-3Medical Subject Headings::Organisms::Bacteria::FirmicutesMedical Subject Headings::Phenomena and Processes::Biological Phenomena::Ecological and Environmental Phenomena::Environment::Ecosystem::Biodiversity::Biota::Microbiota::Gastrointestinal MicrobiomeMedical Subject Headings::Chemicals and Drugs::Carbohydrates::Monosaccharides::Hexoses::GlucoseMedical Subject Headings::Chemicals and Drugs::Carbohydrates::Glycosides::Hemoglobin A, GlycosylatedMedical Subject Headings::Phenomena and Processes::Physiological Phenomena::Physiological Processes::HomeostasisMedical Subject Headings::Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::HumansMedical Subject Headings::Chemicals and Drugs::Hormones, Hormone Substitutes, and Hormone Antagonists::Hormones::Peptide Hormones::Pancreatic Hormones::Insulins::Proinsulin::InsulinMedical Subject Headings::Phenomena and Processes::Physiological Phenomena::Pharmacological Phenomena::Drug Resistance::Insulin ResistanceMedical Subject Headings::Health Care::Health Care Economics and Organizations::Policy::Social Control Policies::Public Policy::Health Policy::Nutrition PolicyMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Nutrition TherapyMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Evaluation Studies as Topic::Pilot ProjectsMedical Subject Headings::Organisms::Bacteria::Bacteroidetes::Bacteroidaceae::PrevotellaMedical Subject Headings::Health Care::Health Care Quality, Access, and Evaluation::Quality of Health Care::Epidemiologic Factors::Causality::Risk Factorsresearch article27090218open access10.1186/s12944-016-0245-01476-511XPMC4836051