Effect of a Postbiotic Intake on Glucose Control and Microbiota Composition of Type 2 Diabetic Su… (NCT06448182) | Clinical Trial Compass
CompletedNot Applicable
Effect of a Postbiotic Intake on Glucose Control and Microbiota Composition of Type 2 Diabetic Subjects: a Randomized Controlled Trial.
Spain106 participantsStarted 2025-01-09
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* Subjects who have received oral antibiotic treatment in the 45 days prior to the start of the study.
* Patients who have started hypoglycemic treatment, especially in the 3 months prior to inclusion. Insulin treatment.
* Severe untreated dyslipidemia, hypertension or hypothyroidism, or treated for less than 3 months.
* Presence of relevant functional or structural anomalies of the digestive system, such as malformations, angiodysplasias, active peptic ulcers, chronic inflammatory diseases or malabsorption.
* Subjects who have undergone surgical interventions of the digestive system with permanent consequences (…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested a postbiotic supplement — which is heat-treated bacteria — to see if it lowered HbA1c in people with type 2 diabetes; given my current HbA1c level, do you think there's any meaningful signal from this kind of approach that's worth discussing for my situation?
2Since this trial is listed as completed, has the results data been published yet, and if so, what did it actually show about changes in blood sugar control?
3This study also looked at changes in gut microbiota composition — do you think the state of my gut health or any medications I'm on, like metformin, might affect whether a postbiotic intervention could even work for me?
4Because this was a Phase NA randomized controlled trial focused on a dietary supplement rather than a drug, how does that affect how confident we can be in any results, and would you consider this strong enough evidence to try alongside my current diabetes management plan?
5Before considering anything like this, would you recommend I focus first on optimizing my existing medications or lifestyle changes, given that those have a longer track record for improving HbA1c?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in blood glycated hemoglobin (HbA1c) concentration
Timeframe: Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Trial details
NCT IDNCT06448182
SponsorClinica Universidad de Navarra, Universidad de Navarra