Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06448182
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-06-03
Brief Title:
Effect of a Postbiotic Intake on Glucose Control and Microbiota Composition of Type 2 Diabetic Subjects a Randomized Controlled Trial
Sponsor:
Clinica Universidad de Navarra Universidad de Navarra
Organization:
Clinica Universidad de Navarra Universidad de Navarra
Study Overview
Official Title:
Precision Medicine Against Type 2 Diabetes Genetic Prediction and Nutritional Intervention With Postbiotics to Modulate Microbiota
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Diabet2Predict
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 ALTAST
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 n79 daily consumption of one postbiotic capsule
Placebo group n79 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
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 ALTAST
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 n79 daily consumption of one postbiotic capsule
Placebo group n79 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None