Effect of postbiotics on glucose control in type 2 diabetes
Precision Medicine Against Type 2 Diabetes: Genetic Prediction and Nutritional Intervention With Postbiotics to Modulate Microbiota.
This study is testing if taking postbiotics can help people with type 2 diabetes better control their blood sugar and improve their overall health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 158 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Clinica Universidad de Navarra, Universidad de Navarra Academic / other |
| Locations | 3 sites (Pamplona, Navarre and 2 other locations) |
| Trial ID | NCT06448182 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the impact of postbiotic intake on glycemic control, insulin resistance, and microbiota composition in individuals with type 2 diabetes. Participants will be randomly assigned to receive either a postbiotic or a placebo over a 12-week period. The study will involve multiple clinical visits where various biochemical, metabolic, and genetic analyses will be conducted, including assessments of glucose levels, lipid metabolism, and microbiota composition through stool samples. The goal is to determine if postbiotics can improve metabolic health in this population.
Who should consider this trial
Good fit: Ideal candidates are men and women aged 18 to 70 with a diagnosis of type 2 diabetes and a BMI between 25 and 39.9 kg/m2.
Not a fit: Patients who have received oral antibiotics in the 45 days prior to the study or those with unstable health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new dietary interventions that improve glucose control and overall metabolic health in patients with type 2 diabetes.
How similar studies have performed: Other studies have shown promising results with postbiotics in metabolic health, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 (for example, gastroduodenostomy). * Suffer from any type of cancer or be undergoing treatment for it, or a period of less than 5 years since its eradication. * Subjects who work rotating shifts that include night shifts. * Presence of some type of psychological impediment such as depressive pathology, anxiety, untreated bipolar disorder. They will be able to participate if they have the disease but with stable treatment for at least 3 months prior to the start of the trial. * Have an allergy or intolerance to any food or food group that is likely to manifest during the study. * Be on a special diet during the 3 months prior to the start of the study, except for treatment for DM2, in this case, the lifestyle/diet will have to be stable in the 3 months prior to the start of the study. * Weight variations (± 5%) during the last 3 months. * Suffer from eating disorders or present restrictive behaviors in their diet. Score on the EAT-26 questionnaire equal to or greater than 20. * Subjects who have undergone surgical treatment for obesity. * Be pregnant or breastfeeding. * Present alcohol abuse (more than 14 units/day in women and 20 units/day in men) and/or drugs. * Show poor collaboration or have difficulties to follow the study procedures. * Take some type of nutritional supplementation that can affect blood glucose and/or the microbiota. If they take it, in order to be included in the study, they will have to stop the supplement, with a washout period of at least 14 days before starting the study.
Where this trial is running
Pamplona, Navarre and 2 other locations
- Clinica Universidad de Navarra — Pamplona, Navarre, Spain (Not_yet_recruiting)
- Nutrition Research Centre, University of Navarra — Pamplona, Navarre, Spain (Recruiting)
- IIS Biobizkaia — Barakaldo, Vizcaya, Spain (Not_yet_recruiting)
Study contacts
- Principal investigator: Pedro González-Muniesa, PhD — Nutrition Research Centre
- Study coordinator: Pedro González-Muniesa, PhD
- Email: pgonmun@unav.es
- Phone: 948425600
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.