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RECRUITING
NCT06448182
NA

Effect of a Postbiotic Intake on Glucose Control and Microbiota Composition of Type 2 Diabetic Subjects: a Randomized Controlled Trial.

Sponsor: Clinica Universidad de Navarra, Universidad de Navarra

View on ClinicalTrials.gov

Summary

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.

Official title: Precision Medicine Against Type 2 Diabetes: Genetic Prediction and Nutritional Intervention With Postbiotics to Modulate Microbiota.

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

158

Start Date

2025-01-09

Completion Date

2025-12-20

Last Updated

2025-02-10

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Postbiotic

1 capsule of postbiotic daily in the morning

DIETARY_SUPPLEMENT

Placebo

1 capsule of placebo daily in the morning

Locations (3)

Clinica Universidad de Navarra

Pamplona, Navarre, Spain

Nutrition Research Centre, University of Navarra

Pamplona, Navarre, Spain

IIS Biobizkaia

Barakaldo, Vizcaya, Spain