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Postprandial Glucose Levels, Gut Microbiota and Supplementation With Functional Foods in Adults (PPGR)

Primary Purpose

Healthy, Nutritional and Metabolic Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Dietary Supplement: A package containing a mix of functional foods
Sponsored by
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy focused on measuring Postprandial glucose responses, Gut microbiota, Functional foods

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Male and female Adults between 18 and 60 years of age. The signing of the informed consent. Exclusion Criteria: Patients with any type of diabetes. Patients with high blood pressure. Patients with acquired diseases secondarily producing obesity and diabetes. Patients who have suffered a cardiovascular event. Patients with gastrointestinal diseases. Weight loss > 3 kg in the last 3 months. Catabolic diseases such as cancer and acquired immunodeficiency syndrome. Pregnancy status. Drug treatment: Antihypertensive drugs or treatment (thiacycline, loop or potassium-sparing diuretics, angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, alpha blockers, calcium antagonists, beta blockers). Treatment with hypoglycemic agents (sulfonylureas, biguanides, incretins) or insulin and antidiabetic drugs. Treatment with statins, fibrates or other drugs to control dyslipidemia. Use of antibiotics in the three months prior to the study. Use of steroid drugs, chemotherapy, immunosuppressants, or radiation therapy. Anorexigenic or that accelerate weight loss such as sibutramine or orlistat. Supplements with any of the functional foods used in the study. Probiotic, prebiotic or symbiotic supplements.

Sites / Locations

  • Instituto Nacional de Ciencias Médicas y Nutrición Salvador ZubiránRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nutritional strategy based on functional foods

Arm Description

Participants will be provided with a nutritional strategy based on functional foods to use over the 2 week trial. These will be nopal, chía seeds, inulin, soy protein, agave extract and genistein.

Outcomes

Primary Outcome Measures

Changes in postprandial glucose responses
Postprandial glucose concentrations (mmol/L). The incremental area under the curve will be calculated and expressed as mmol*minutes/litre.
Changes in diversity analysis of intestinal microbiota with and without intervention with functional foods
Based on the gene and species composition of each sample, the Chao1 and Shannon indexes, as well as the observed operational taxonomic units, will be calculated in order to identify the differences in gene and species diversity for each group

Secondary Outcome Measures

Changes in metabolite profiles of urine with and without intervention with functional foods
Metabolite profiles will be analyzed using a semi targeted screening approach with multiple Schedule multiple reaction monitoring-independent data acquisition-enhanced product ion (sMRM-IDA-EPI) experiments in an liquid chromatography-mass spectrometer-triple quadrupole with linear trap mass spectrometer (LC-MS-QTRAP) metabolomic platform. The concentration of the identified metabolites in the different urinary fractions will be expressed in relative intensities. From the latter, putative biomarkers may be obtained to determine the fingerprint of the dietary intervention assessed in this clinical trial.
Feasibility of the functional food treatment decision algorithm. Proportion of patients with presumed improvement in postprandial glucose response who have completed the algorithm.
The algorithm will be considered completed if a decision to initiate functional food intervention has been taken at any step of the algorithm or if improvement in the prediction of postprandial glucose response has been excluded after systematic evaluation, and all steps planned in the algorithm have been implemented.

Full Information

First Posted
January 17, 2023
Last Updated
June 7, 2023
Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Collaborators
Fundación Gonzalo Río Arronte
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1. Study Identification

Unique Protocol Identification Number
NCT05723913
Brief Title
Postprandial Glucose Levels, Gut Microbiota and Supplementation With Functional Foods in Adults
Acronym
PPGR
Official Title
Postprandial Glucose Levels, Gut Microbiota and Supplementation With Functional Foods in Adults
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 7, 2023 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Collaborators
Fundación Gonzalo Río Arronte

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a clinical study with participants over 18 years of age that meet the selection criteria. This will be 42-day study divided into three phases of 14 days each: 14 days without intervention, 14 days with intervention with functional foods and 14 days without intervention again. With the objective of assess the changes in the postprandial glycemic responses through the gut microbiota and urine metabolites.
Detailed Description
The increase in postprandial blood glucose constitutes a global epidemic and an important risk factor for the development of prediabetes and type 2 diabetes (T2D). In addition, the elevated postprandial glycemic responses (PPGRs) are an independent risk factor for the development of T2D and are associated with the presence of obesity. Therefore the prediction of PPGRs is a tool that could be used to maintain normal blood glucose concentrations. Studies have shown inter and intrapersonal differences in PPGRs after consuming the same amount of the same food. Factors that can affect interpersonal differences in PPGRs include genetics, lifestyle, and insulin sensitivity. Another factor that may be involved is the gut microbiota. The objective of this study is to characterize the postprandial blood glucose levels, gut microbiota and urine metabolites in participants over 18 years of age after a functional foods intervention and observed whether this intervention modifies the postprandial glycemic response through the gut microbiota and urine metabolites. This will be a 42-day study divided into three phases of 14 days each where the patient will attend four visits: at day 1, 14, 28 and 42. 200 adults who meet the inclusion criteria will be recruited. During the three phases a continuous glucose monitor will be taking intersticial glucose concentrations every 15 min., divided into three phases of 14 days each: 14 days without intervention, 14 days with intervention with functional foods and 14 days without intervention again.In the three phases the following will be determined; anthropometric and biochemical parameters, food consumption, physical activity, lifestyle, metabolites in urine as well as determination of the composition of the intestinal microbiota.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Nutritional and Metabolic Diseases
Keywords
Postprandial glucose responses, Gut microbiota, Functional foods

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nutritional strategy based on functional foods
Arm Type
Experimental
Arm Description
Participants will be provided with a nutritional strategy based on functional foods to use over the 2 week trial. These will be nopal, chía seeds, inulin, soy protein, agave extract and genistein.
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary Supplement: A package containing a mix of functional foods
Intervention Description
Participants will be provided with a nutritional strategy based on functional foods to use over the 2 week trial. These will be nopal, chía seeds, inulin, soy protein, agave extract and genistein.
Primary Outcome Measure Information:
Title
Changes in postprandial glucose responses
Description
Postprandial glucose concentrations (mmol/L). The incremental area under the curve will be calculated and expressed as mmol*minutes/litre.
Time Frame
6 weeks
Title
Changes in diversity analysis of intestinal microbiota with and without intervention with functional foods
Description
Based on the gene and species composition of each sample, the Chao1 and Shannon indexes, as well as the observed operational taxonomic units, will be calculated in order to identify the differences in gene and species diversity for each group
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Changes in metabolite profiles of urine with and without intervention with functional foods
Description
Metabolite profiles will be analyzed using a semi targeted screening approach with multiple Schedule multiple reaction monitoring-independent data acquisition-enhanced product ion (sMRM-IDA-EPI) experiments in an liquid chromatography-mass spectrometer-triple quadrupole with linear trap mass spectrometer (LC-MS-QTRAP) metabolomic platform. The concentration of the identified metabolites in the different urinary fractions will be expressed in relative intensities. From the latter, putative biomarkers may be obtained to determine the fingerprint of the dietary intervention assessed in this clinical trial.
Time Frame
6 weeks
Title
Feasibility of the functional food treatment decision algorithm. Proportion of patients with presumed improvement in postprandial glucose response who have completed the algorithm.
Description
The algorithm will be considered completed if a decision to initiate functional food intervention has been taken at any step of the algorithm or if improvement in the prediction of postprandial glucose response has been excluded after systematic evaluation, and all steps planned in the algorithm have been implemented.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male and female Adults between 18 and 60 years of age. The signing of the informed consent. Exclusion Criteria: Patients with any type of diabetes. Patients with high blood pressure. Patients with acquired diseases secondarily producing obesity and diabetes. Patients who have suffered a cardiovascular event. Patients with gastrointestinal diseases. Weight loss > 3 kg in the last 3 months. Catabolic diseases such as cancer and acquired immunodeficiency syndrome. Pregnancy status. Drug treatment: Antihypertensive drugs or treatment (thiacycline, loop or potassium-sparing diuretics, angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, alpha blockers, calcium antagonists, beta blockers). Treatment with hypoglycemic agents (sulfonylureas, biguanides, incretins) or insulin and antidiabetic drugs. Treatment with statins, fibrates or other drugs to control dyslipidemia. Use of antibiotics in the three months prior to the study. Use of steroid drugs, chemotherapy, immunosuppressants, or radiation therapy. Anorexigenic or that accelerate weight loss such as sibutramine or orlistat. Supplements with any of the functional foods used in the study. Probiotic, prebiotic or symbiotic supplements.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Armando R Tovar, Doctor
Phone
52 5554870900
Ext
2802
Email
tovar.ar@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Martha Guevara-Cruz, Doctor
Phone
525554870900
Ext
2802
Email
marthaguevara8@yahoo.com.mx
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Armando R Tovar, Doctor
Organizational Affiliation
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubiran
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
City
México
State/Province
Mexico City
ZIP/Postal Code
14080
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Armando R Tovar, Dr
Phone
5554870900
Ext
2801
Email
tovar.ar@gmail.com
First Name & Middle Initial & Last Name & Degree
Rocio Guizar-Heredia, MsC
Phone
5554870900
Ext
2802
Email
rg_heredia@hotmail.com
First Name & Middle Initial & Last Name & Degree
Martha Guevara-Cruz, Dr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Citation
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Postprandial Glucose Levels, Gut Microbiota and Supplementation With Functional Foods in Adults

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