Actively Recruiting
Effect of a Postbiotic Intake on Glucose Control and Microbiota Composition of Type 2 Diabetic Subjects: a Randomized Controlled Trial.
Led by Clinica Universidad de Navarra, Universidad de Navarra · Updated on 2025-02-10
158
Participants Needed
3
Research Sites
49 weeks
Total Duration
On this page
Sponsors
C
Clinica Universidad de Navarra, Universidad de Navarra
Lead Sponsor
B
Biobizkaia Health Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Effect of a Postbiotic Intake on Glucose Control and Microbiota Composition of Type 2 Diabetic Subjects: a Randomized Controlled Trial.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged between 18 and 70 years.
- Diagnosed with type 2 diabetes with HbA1c 6.5% and/or fasting glucose 126 mg/dL.
- Body mass index (BMI) between 25 and 39.9 kg/m2.
- Stable treatment for diabetes and other conditions for at least 3 months before study start.
- Stable baseline HbA1c or glucose for at least 3 months before starting.
- No weight changes greater than �b15% in the last 3 months.
- General physical and psychological health suitable for the study.
- Able to understand and willing to sign informed consent and comply with study procedures.
You will not qualify if you...
- Use of oral antibiotics in the 45 days before the study.
- Started hypoglycemic treatment, especially in the last 3 months; insulin treatment.
- Severe untreated or newly treated (<3 months) dyslipidemia, hypertension, or hypothyroidism.
- Significant digestive system issues such as malformations, ulcers, inflammatory diseases, or malabsorption.
- Past digestive system surgery with permanent effects.
- Current cancer or cancer treatment, or less than 5 years since eradication.
- Working rotating night shifts.
- Psychological disorders unless stable treatment for at least 3 months.
- Food allergies or intolerances likely to appear during study.
- Special diets in the past 3 months except stable diabetes-related diet.
- Weight changes greater than �b15% in the last 3 months.
- Eating disorders or restrictive eating behaviors (EAT-26 score 20).
- Prior surgical treatment for obesity.
- Pregnancy or breastfeeding.
- Alcohol abuse (>14 units/day women, >20 units/day men) or drug use.
- Poor cooperation or difficulty following study procedures.
- Use of nutritional supplements affecting blood glucose or microbiota without a 14-day washout before study start.
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Trial Site Locations
Total: 3 locations
1
Clinica Universidad de Navarra
Pamplona, Navarre, Spain, 31008
Not Yet Recruiting
2
Nutrition Research Centre, University of Navarra
Pamplona, Navarre, Spain, 31008
Actively Recruiting
3
IIS Biobizkaia
Barakaldo, Vizcaya, Spain, 48903
Not Yet Recruiting
Research Team
P
Pedro González-Muniesa, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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