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

NCT06448182 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2026-05-19

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DIETARY_SUPPLEMENT

Postbiotic

1 capsule of postbiotic daily in the morning

DIETARY_SUPPLEMENT

Placebo

1 capsule of placebo daily in the morning

Sponsors & Collaborators

  • Biobizkaia Health Research Institute

    collaborator OTHER_GOV

  • Genbioma Aplicaciones S.L.

    collaborator UNKNOWN

  • Clinica Universidad de Navarra, Universidad de Navarra

    lead OTHER

Principal Investigators

  • Pedro González-Muniesa, PhD · Nutrition Research Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-09
Primary Completion
2025-12-30
Completion
2025-12-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06448182 on ClinicalTrials.gov