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

NCT06448182 | Recruiting DMC

• 1 other identifier: DIABET2PREDICT (2024.055)
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Obesity; Postbiotic; Microbiota; Genetics; Randomized Controlled Trial; Supplementation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (31)

• Change from baseline in blood glucose

  Clinical Investigation Days 1 (week 0), 2 (week 2), 3 (week 10) and 4 (week 12).

• Change from baseline in blood insulin

  Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).

• Continuous glucose levels

  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

  Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).

• Change from baseline in hemogram

  Clinical Investigation Day 1 (week 0) and Clinical Investigation Day 4 (week 12).

Study Arms (2)

Postbiotic group

EXPERIMENTAL

1 postbiotic capsule daily in the morning during 12 weeks

Dietary Supplement: Postbiotic

Placebo group

PLACEBO COMPARATOR

1 placebo capsule daily in the morning during 12 weeks

Dietary Supplement: Placebo

Interventions

Postbiotic DIETARY_SUPPLEMENT

1 capsule of postbiotic daily in the morning

Postbiotic group

Placebo DIETARY_SUPPLEMENT

1 capsule of placebo daily in the morning

Placebo group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Subjects who have received oral antibiotic treatment in the 45 days prior to the start of the study.
• 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.

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead
• Biobizkaia: collaborator
• Genbioma Aplicaciones S.L.: collaborator

Study Sites (3)

Clinica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

NOT YET RECRUITING

Nutrition Research Centre, University of Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

IIS Biobizkaia

Barakaldo, Vizcaya, 48903, Spain

NOT YET RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pedro González-Muniesa, PhD

  Nutrition Research Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pedro González-Muniesa, PhD

CONTACT

948425600; pgonmun@unav.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The products (experimental and placebo), will be produced by an external producer, who will save the codes. None of the researchers involved in the study development or analyses will know the association until the end of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised, double blinded, parallel intervention

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 7, 2024
• Study Start: January 9, 2025
• Primary Completion: June 30, 2025
• Study Completion: December 20, 2025
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)