Precision Medicine Against Type 2 Diabetes: Genetic Prediction and Nutritional Intervention With Postbiotics to Modulate Microbiota.
The goal of this randomized clinical trial is to evaluate the effect of the administration of a postbiotic on glycemic control, insulin resistance and microbiota composition in subjects with type 2 diabetes. The main questions it aims to answer are: * Study the evolution of biochemical variables related to glycemic metabolism: basal glucose, basal insulin, glycemic variability through sensors, glycosylated hemoglobin (HbA1c), HOMA-IR index, C peptide. * Perform a metagenomic analysis of intestinal microbiota in stool samples. * Perform a metabolomics analysis on blood samples. * Analyze the genetic profile in blood. * Evaluate the evolution of biochemical variables related to lipid metabolism: total serum cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides. * Assess the evolution of variables related to liver function: transaminases (ALT/AST). * Analyze the evolution of the blood count. * Evaluate the evolution of anthropometric variables (weight, height, waist and hip) and body composition. * Analyze the evolution of blood pressure. * Analyze eating and physical activity habits. * Evaluate adherence to treatment and adverse events. * Personalization on the use of postbiotics and other nutritional recommendations based on the genetic profile and the identification of patient clusters. For this purpose, a randomized, double blind parallel study has been designed. Target sample size is 158 subjects. Participants will be allocated in two groups for 12 weeks: * Experimental group (n=79): daily consumption of one postbiotic capsule. * Placebo group (n=79): daily consumption of one placebo capsule. Researchers will compare the consumption of a postbiotic supplement to a placebo. Participants will visit nutritional intervention unit at week 0, week 2, week 10 and week 12 of the study.
• Men and women aged between 18 and 70 years.
• Subjects diagnosed with DM2: glycosylated hemoglobin (HbA1c) ≥6.5% and/or basal glucose ≥126 mg/dL. Debut time will not be taken into account.
• Body Mass Index (BMI) between 25 and 39.9 kg/m2.
• Treatment for DM2/stable lifestyle, as well as other treatments for other pathologies (stable at least 3 months prior to the start of the intervention).
• Stable baseline HbA1c or glucose value for at least 3 months before starting the intervention.
• No weight variations (± 5%) during the last 3 months.
• Subjects must be in general physical and psychological conditions that the researcher assesses in accordance with the objective of the study.
• Subjects must be able to understand and be willing to sign the informed consent, and must comply with all study procedures and requirements.