RecruitingNot ApplicableNCT06448182

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

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


Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Enrollment

158 participants

Start Date

Jan 9, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether taking a postbiotic supplement (a product made from beneficial bacteria) can help control blood sugar levels and improve gut bacteria composition in people with type 2 diabetes. **You may be eligible if...** - You are between 18 and 70 years old - You have been diagnosed with type 2 diabetes (HbA1c ≥6.5% or fasting glucose ≥126 mg/dL) - Your BMI is between 25 and 39.9 - Your diabetes management has been stable for at least 3 months - Your weight has been stable (within 5%) for the last 3 months **You may NOT be eligible if...** - You have recently changed your diabetes medications or lifestyle significantly - You have major health conditions that could interfere with the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTPostbiotic

1 capsule of postbiotic daily in the morning

DIETARY_SUPPLEMENTPlacebo

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

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NCT06448182


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