Validation of Urinary Biomarkers of Dietary Intake in Mexican Foods: a Randomize Controlled Trial

January 8, 2025 updated by: Daniel Illescas Zárate, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
A randomized controlled open-label trial will be conducted in Mexico City, recruiting healthy participants who do not consume excessive alcohol or smoke. A selection visit will be conducted during which blood and urine samples will be collected, and assessments of diet, anthropometric measurements, and body composition will be performed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A randomized controlled open-label trial will be conducted in Mexico City, recruiting healthy participants who do not consume excessive alcohol or smoke. A selection visit will be conducted during which blood and urine samples will be collected, and assessments of diet, anthropometric measurements, and body composition will be performed.

Participants will be randomized into three groups for the intake of meals containing the foods of interest and control without these foods. After the meal consumption including foods of interest, a 24-hour urine sample will be collected by the participants. Urine and blood samples will be analyzed using using untargeted metabolomics in different platforms to determine biomarker concentrations.

Study Type

Interventional

Enrollment (Actual)

92

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 Locations

  • Mexico
      • Mexico City, Mexico, 14080
        • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age 18 years and older
  • Body mass index (BMI ) between 18.5 to 30 kg/m2
  • Not having allergies to the study foods (ataulfo mango, nopal, guava, avocado, corn tortilla and amaranth).
  • Without consumption of dietary supplements at the time of participating in the study.
  • Blood chemistry within reference values (glucose <126 mg/dL, triglycerides <250 mg/dL, total cholesterol <250 mg/dL.

Exclusion Criteria:

  • The exclusion criteria were participants with any other chronic disease diagnosed by any doctor.
  • Were pregnant.
  • Smoking habit durig the trial.
  • Intake of alcoholic beverages during the trial.

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: high intake group
Intake of meals containing the foods of interest avocado, corn tortilla, nopal, guava, mango, amaranth in the breakfast.
Other: High intake group
Intake of a breakfast containing the foods of interest avocado (80gr), corn tortilla (60 gr), nopal (200 gr), guava (108 gr), mango (100 gr), amaranth (14 gr).
Experimental: Average intake group
Intake of meals containing the foods of interest avocado, corn tortilla, nopal, guava, mango, amaranth in the breakfast.
Other: Average intake group
Intake of a breakfast containing the foods of interest avocado (40gr), corn tortilla (30 gr), nopal (100 gr), guava (54 gr), mango (50 gr), amaranth (7 gr).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploratory biomarkers of food intake
Time Frame: one day
Mangiferin and pyrogallol for mango, peseitol, mannoheptulosa for avocado, and opuntiol for nopal.
one day

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

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)

July 1, 2024

Primary Completion (Actual)

December 1, 2024

Study Completion (Actual)

December 1, 2024

Study Registration Dates

First Submitted

January 8, 2025

First Submitted That Met QC Criteria

January 8, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 8, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 5113

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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