Diabetes Mellitus, Type 2Diabet2PredictNCT06448182
Effect of a Postbiotic Intake on Glucose Control and Microbiota Composition of Type 2 Diabetic Subjects: a Randomized Controlled Trial.
A study testing Postbiotic in people with Diabetes Mellitus, Type 2, run by Clinica Universidad de Navarra, Universidad de Navarra at 3 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Postbiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 3 sitesSpain
- Study dates
- 9 Jan 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
IIS Biobizkaia
Barakaldo, Vizcaya, 48903
Clinica Universidad de Navarra
Pamplona, Navarre, 31008
Nutrition Research Centre, University of Navarra
Pamplona, Navarre, 31008
About this study
Official title: Precision Medicine Against Type 2 Diabetes: Genetic Prediction and Nutritional Intervention With Postbiotics to Modulate Microbiota.
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:
Read more
- 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.
Read the detailed description
Volunteers who wish to participate in the study will be interviewed by phone to verify that they meet the main inclusion criteria. Volunteers who meet the main inclusion criteria will be invited to an information and screening visit to resolve any doubts. Volunteers who agree to participate in the study will sign the informed consent and will be randomly allocated to one of the two arms of the study and will be provided with any required material.
During the intervention, volunteers will attend 4 Clinical investigation visits. The first one will be carried out on the first day of the study and the last one will take place at the end of the 12 weeks. In both visits anthropometric and body composition measurements, blood pressure, stool and blood samples, as well as data about dietary, physical activity and gastrointestinal symptoms will be taken. In the second and the third visits anthropometric, body composition, blood pressure and a blood sample will be taken. In the first and the third visits glucose monitoring sensor will be put and in the second and the fourth visits this glucosae monitoring sensor will be retired.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Postbiotic, Placebo
- Keywords
- Obesity, Postbiotic, Microbiota, Genetics, Randomized Controlled Trial, Supplementation
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PostbioticDietary supplement
1 capsule of postbiotic daily in the morning
PlaceboDietary supplement
1 capsule of placebo daily in the morning
| Study group | Role | What they receive |
|---|---|---|
| Postbiotic group | Experimental | 1 postbiotic capsule daily in the morning during 12 weeks Receives: Dietary Supplement: Postbiotic |
| Placebo group | Placebo comparator | 1 placebo capsule daily in the morning during 12 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in blood glycated hemoglobin (HbA1c) concentration
Blood glycated hemoglobin will be analysed in total blood and reported in % and in mmol/mol.
Measured: Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Secondary outcomes (31)
Change from baseline in blood glucose
Blood will be extracted at fasting state and glucose levels will be determined by autoanalyzer Pentra-C200.
Measured: Clinical Investigation Days 1 (week 0), 2 (week 2), 3 (week 10) and 4 (week 12).
Change from baseline in blood insulin
Blood will be extracted at fasting state and insulin levels will be determined by ELISA.
Measured: Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Continuous glucose levels
Continuous glucose levels will be controlled with FreeStyle Libre Pro (Abbott) glucose monitoring sensor.
Measured: Clinical Investigation Day 1 (week 0) to Clinical Investigation Day 2 (week 2) and Clinical Investigation Day 3 (week 10) to Clinical Investigation Day 4 (week 12).
Change from baseline in blood Peptide C
Blood will be extracted at fasting state and peptido C levels will be determined by ELISA.
Measured: Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Change from baseline in hemogram
Blood will be extracted at fasting state and hemogram profile will be determined by autoanalyzer Pentra-C60.
Measured: Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Change from baseline in fecal microbiota
Fecal microbiota of participants will be analyzed by bacterial 16S gene sequencing technology.
Measured: Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Blood genetic profile
Genetic profile will be analysed in blood of participants.
Measured: Clinical investigation day 1
Change from baseline in blood total cholesterol
Blood will be extracted at fasting state and Total cholesterol levels of participants will be analysed by autoanalyzer Pentra-C200.
Measured: Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Change from baseline in blood HDL cholesterol
Blood will be extracted at fasting state and HDL cholesterol levels of participants will be analysed by autoanalyzer Pentra-C200.
Measured: Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Change from baseline in blood LDL cholesterol
LDL cholesterol levels of participants will be calculted by Friedewald equation.
Measured: Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Change from baseline in blood tryglicerides
Blood will be extracted at fasting state and trygliceride levels of participants will be analysed by autoanalyzer Pentra-C200.
Measured: Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Change from baseline in blood lactate
Blood will be extracted at fasting state and lactate levels of participants will be analysed by autoanalyzer Pentra-C200.
Measured: Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Change from baseline in blood alanine aminotransferase (ALT)
Blood will be extracted at fasting state and ALT levels of participants will be analysed by autoanalyzer Pentra-C200.
Measured: Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Change from baseline in blood aspartate aminotransferase (AST)
Blood will be extracted at fasting state and AST levels of participants will be analysed by autoanalyzer Pentra-C200.
Measured: Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Change from baseline in body weight
Weight of participants will be measured by bioimpedance and reported in kg.
Measured: Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Height
Height of participants will be measured by stadiometer and reported in m.
Measured: Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Change from baseline in body mass index
Body mass index will be calculated as follows: weight (kilograms)/ height (cm)2.
Measured: Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Change from baseline in body fat percentage
Body fat of participants will be analyzed by bioimpedance and reported in percentage and kilograms.
Measured: Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Change from baseline in body muscle mass
Body muscle mass of participants will be analyzed by bioimpedance and reported in kilograms.
Measured: Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Change from baseline in body lean mass
Body leen mass of participants will be analyzed by bioimpedance and reported in kilograms.
Measured: Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Change from baseline in body water mass
Body water mass of participants will be analyzed by bioimpedance and reported in kilograms.
Measured: Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Change from baseline in body bone mass
Body bone mass of participants will be analyzed by bioimpedance and reported in kilograms.
Measured: Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Change from baseline in waist circumference
Waist circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.
Measured: Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Change from baseline in hip circumference
Hip circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.
Measured: Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Change from baseline in systolic blood pressure
Systolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg.
Measured: Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Change from baseline in diastolic blood pressure
Diastolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg.
Measured: Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Change from baseline in heart rate
Heart rate of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg.
Measured: Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Change from baseline in gastrointestinal symptoms
Gastrointestinal symptoms will be registrated through Gastrointestinal Symptoms Rating Scale questionnaire, which is a questionnaire of 15 items. The questionnaire has a seven-point graded likert-type scale, where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.
Measured: Clinical investigation day 1 (week 0), 2 (week 2), 3 (week 10) and 4 (week 12).
Change from baseline in physical activity
Physical activity will be evaluated by the reduced version of the International Physical Activity Questionnaire, which estimates the total physical activity in MET-min/week, time spent sitting and classifies subjects based on their physical activity.
Measured: Clinical investigation day 1 (week 0) and 4 (week 12).
Change from baseline in global dietary intake
Global dietary intake (energy, macronutrients and micronutrients) will be analysed by food frequency questionnaire.
Measured: Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Change from baseline in adherence to capsule consumption
Adherence will be assessed using the capsule consumption record form.
Measured: Clinical investigation day 1 (week 0), 2 (week 2), 3 (week 10) and 4 (week 12).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start9 Jan 2025
- Primary completion30 Dec 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, double blinded, parallel intervention
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Collaborators
- Biobizkaia Health Research Institute, Genbioma Aplicaciones SL
- Responsible party
- Sponsor
- Investigators
- Pedro González-Muniesa, PhD, Principal investigator, Nutrition Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06448182
- Sponsor's protocol ID
- DIABET2PREDICT (2024.055)
- Acronym
- Diabet2Predict
- Status last verified
- May 2026
- First submitted
- 3 Jun 2024
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Medicine Against Type 2 Diabetes: Genetic Prediction and Nutritional Intervention With Postbiotics to Modulate Microbiota.
- ClinicalTrials.gov ID
- NCT06448182
- Acronym / sponsor ID
- Diabet2Predict / DIABET2PREDICT (2024.055)
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Obesity, Postbiotic, Microbiota, Genetics, Randomized Controlled Trial, Supplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Collaborators
- Biobizkaia Health Research Institute, Genbioma Aplicaciones SL
- Study start
- 9 Jan 2025 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 7 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Volunteers who wish to participate in the study will be interviewed by phone to verify that they meet the main inclusion criteria. Volunteers who meet the main inclusion criteria will be invited to an information and screening visit to resolve any doubts. Volunteers who agree to participate in the study will sign the informed consent and will be randomly allocated to one of the two arms of the study and will be provided with any required material.
During the intervention, volunteers will attend 4 Clinical investigation visits. The first one will be carried out on the first day of the study and the last one will take place at the end of the 12 weeks. In both visits anthropometric and body composition measurements, blood pressure, stool and blood samples, as well as data about dietary, physical activity and gastrointestinal symptoms will be taken. In the second and the third visits anthropometric, body composition, blood pressure and a blood sample will be taken. In the first and the third visits glucose monitoring sensor will be put and in the second and the fourth visits this glucosae monitoring sensor will be retired.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised, double blinded, parallel intervention
| Arm | Type | Receives |
|---|---|---|
| Postbiotic group | Experimental | Dietary Supplement: Postbiotic1 postbiotic capsule daily in the morning during 12 weeks |
| Placebo group | Placebo comparator | Dietary Supplement: Placebo1 placebo capsule daily in the morning during 12 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (17 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postbiotic1 capsule of postbiotic daily in the morning | Dietary supplement | Postbiotic group |
| Placebo1 capsule of placebo daily in the morning | Dietary supplement | Placebo group |
Primary outcome
Change from baseline in blood glycated hemoglobin (HbA1c) concentration
Time frame: Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Blood glycated hemoglobin will be analysed in total blood and reported in % and in mmol/mol.
31 secondary outcomes
Change from baseline in blood glucose
Time frame: Clinical Investigation Days 1 (week 0), 2 (week 2), 3 (week 10) and 4 (week 12).
Change from baseline in blood insulin
Time frame: Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Continuous glucose levels
Time frame: Clinical Investigation Day 1 (week 0) to Clinical Investigation Day 2 (week 2) and Clinical Investigation Day 3 (week 10) to Clinical Investigation Day 4 (week 12).
Change from baseline in blood Peptide C
Time frame: Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Change from baseline in hemogram
Time frame: Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Change from baseline in fecal microbiota
Time frame: Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Blood genetic profile
Time frame: Clinical investigation day 1
Change from baseline in blood total cholesterol
Time frame: Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Change from baseline in blood HDL cholesterol
Time frame: Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Change from baseline in blood LDL cholesterol
Time frame: Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Change from baseline in blood tryglicerides
Time frame: Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Change from baseline in blood lactate
Time frame: Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Change from baseline in blood alanine aminotransferase (ALT)
Time frame: Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Change from baseline in blood aspartate aminotransferase (AST)
Time frame: Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Change from baseline in body weight
Time frame: Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Height
Time frame: Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Change from baseline in body mass index
Time frame: Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Change from baseline in body fat percentage
Time frame: Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Change from baseline in body muscle mass
Time frame: Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Change from baseline in body lean mass
Time frame: Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Change from baseline in body water mass
Time frame: Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Change from baseline in body bone mass
Time frame: Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Change from baseline in waist circumference
Time frame: Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Change from baseline in hip circumference
Time frame: Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Change from baseline in systolic blood pressure
Time frame: Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Change from baseline in diastolic blood pressure
Time frame: Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Change from baseline in heart rate
Time frame: Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Change from baseline in gastrointestinal symptoms
Time frame: Clinical investigation day 1 (week 0), 2 (week 2), 3 (week 10) and 4 (week 12).
Change from baseline in physical activity
Time frame: Clinical investigation day 1 (week 0) and 4 (week 12).
Change from baseline in global dietary intake
Time frame: Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Change from baseline in adherence to capsule consumption
Time frame: Clinical investigation day 1 (week 0), 2 (week 2), 3 (week 10) and 4 (week 12).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: No
Related trials for Diabetes Mellitus, Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedro González-Muniesa, PhD principal investigator
Nutrition Research Centre
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postbiotic in people with Diabetes Mellitus, Type 2, run by Clinica Universidad de Navarra, Universidad de Navarra at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in blood glycated hemoglobin (HbA1c) concentration (time frame: Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.