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

June 13, 2025 updated by: Armando Tovar, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Armando R Tovar, Doctor
  • Phone Number: 2802 52 5554870900
  • Email: tovar.ar@gmail.com

Study Contact Backup

Study Locations

  • Mexico
    • Mexico City
      • México, Mexico City, Mexico, 14080
        • Recruiting
        • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Martha Guevara-Cruz, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nutritional strategy based on functional foods
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.
Dietary supplement: Dietary Supplement: A package containing a mix of functional foods
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in postprandial glucose responses
Time Frame: 6 weeks
Postprandial glucose concentrations (mmol/L). The incremental area under the curve will be calculated and expressed as mmol*minutes/litre.
6 weeks
Changes in diversity analysis of intestinal microbiota with and without intervention with functional foods
Time Frame: 6 weeks
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
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of the functional food treatment decision algorithm. Proportion of patients with presumed improvement in postprandial glucose response who have completed the algorithm.
Time Frame: 2 weeks
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.
2 weeks
Changes in metabolite profiles of urine with and without intervention with functional foods
Time Frame: 6 weeks

Metabolite profiles will be analyzed using a semi targeted screening approach with multiple Schedule multiple reaction monitoring-independent data acquisition-enhanced product ion experiments in an liquid chromatography-mass spectrometer-triple quadrupole with linear trap mass spectrometer 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.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Collaborators

Fundación Gonzalo Río Arronte

Investigators

  • Principal Investigator: Armando R Tovar, Doctor, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

January 17, 2023

First Submitted That Met QC Criteria

February 1, 2023

First Posted (Actual)

February 13, 2023

Study Record Updates

Last Update Posted (Actual)

June 18, 2025

Last Update Submitted That Met QC Criteria

June 13, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3312B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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