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

Diabetes Mellitus, Type 2 Clinical Trial

— Diabet2Predict  

Official title:

Precision Medicine Against Type 2 Diabetes: Genetic Prediction and Nutritional Intervention With Postbiotics to Modulate Microbiota.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06448182
• Other study ID #: 2024.055
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 3, 2024
• Est. completion date: December 20, 2025

Study information

• Verified date: May 2024
• Source: Clinica Universidad de Navarra, Universidad de Navarra
• Contact: Pedro González-Muniesa, PhD
• Phone: 948425600
• Email: pgonmun[@]unav.es
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 158
• Est. completion date: December 20, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

• 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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Dietary Supplement:
• Postbiotic
1 capsule of postbiotic daily in the morning
• Placebo
1 capsule of placebo daily in the morning

Locations

Country	Name	City	State
Spain	IIS Biobizkaia	Barakaldo	Vizcaya
Spain	Clinica Universidad de Navarra	Pamplona	Navarra
Spain	Nutrition Research Centre, University of Navarra	Pamplona	Navarra

Sponsors (3)

Lead Sponsor	Collaborator
Clinica Universidad de Navarra, Universidad de Navarra	Biobizkaia, Genbioma Aplicaciones S.L.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Secondary	Change from baseline in blood glucose	Blood will be extracted at fasting state and glucose levels will be determined by autoanalyzer Pentra-C200.	Clinical Investigation Days 1 (week 0), 2 (week 2), 3 (week 10) and 4 (week 12).
Secondary	Change from baseline in blood insulin	Blood will be extracted at fasting state and insulin levels will be determined by ELISA.	Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Secondary	Continuous glucose levels	Continuous glucose levels will be controlled with FreeStyle Libre Pro (Abbott) glucose monitoring sensor.	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).
Secondary	Change from baseline in blood Peptide C	Blood will be extracted at fasting state and peptido C levels will be determined by ELISA.	Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Secondary	Change from baseline in hemogram	Blood will be extracted at fasting state and hemogram profile will be determined by autoanalyzer Pentra-C60.	Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Secondary	Change from baseline in fecal microbiota	Fecal microbiota of participants will be analyzed by bacterial 16S gene sequencing technology.	Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Secondary	Blood genetic profile	Genetic profile will be analysed in blood of participants.	Clinical investigation day 1
Secondary	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.	Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Secondary	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.	Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Secondary	Change from baseline in blood LDL cholesterol	LDL cholesterol levels of participants will be calculted by Friedewald equation.	Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Secondary	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.	Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Secondary	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.	Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Secondary	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.	Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Secondary	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.	Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Secondary	Change from baseline in body weight	Weight of participants will be measured by bioimpedance and reported in kg.	Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Secondary	Height	Height of participants will be measured by stadiometer and reported in m.	Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Secondary	Change from baseline in body mass index	Body mass index will be calculated as follows: weight (kilograms)/ height (cm)2.	Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Secondary	Change from baseline in body fat percentage	Body fat of participants will be analyzed by bioimpedance and reported in percentage and kilograms.	Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Secondary	Change from baseline in body muscle mass	Body muscle mass of participants will be analyzed by bioimpedance and reported in kilograms.	Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Secondary	Change from baseline in body lean mass	Body leen mass of participants will be analyzed by bioimpedance and reported in kilograms.	Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Secondary	Change from baseline in body water mass	Body water mass of participants will be analyzed by bioimpedance and reported in kilograms.	Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Secondary	Change from baseline in body bone mass	Body bone mass of participants will be analyzed by bioimpedance and reported in kilograms.	Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Secondary	Change from baseline in waist circumference	Waist circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.	Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Secondary	Change from baseline in hip circumference	Hip circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.	Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Secondary	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.	Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Secondary	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.	Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Secondary	Change from baseline in heart rate	Heart rate of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg.	Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Secondary	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.	Clinical investigation day 1 (week 0), 2 (week 2), 3 (week 10) and 4 (week 12).
Secondary	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.	Clinical investigation day 1 (week 0) and 4 (week 12).
Secondary	Change from baseline in global dietary intake	Global dietary intake (energy, macronutrients and micronutrients) will be analysed by food frequency questionnaire.	Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Secondary	Change from baseline in dietary intake by 3 day food record questionnaire	Dietary intake (energy, macronutrients and micronutrients) will be analysed by 3 day food record.	Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).
Secondary	Change from baseline in adherence to capsule consumption	Adherence will be assessed using the capsule consumption record form.	Clinical investigation day 1 (week 0), 2 (week 2), 3 (week 10) and 4 (week 12).