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

Not Applicable

Completed

• Conditions: Nutrition, Biomarkers of Intake, Urinary Biomarkers, Foodomics, Metabolom

• Registration Number: NCT06773078
• Lead Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Brief Summary

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.

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 Timeline

• Study Start: 2024-07-01
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01
• Status Verified: 2025-01
• Study First Submitted: 2025-01-08
• Study First Submitted QC: 2025-01-08
• Last Update Submitted: 2025-01-08
• Study First Posted: 2025-01-14
• Last Update Posted: 2025-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Exploratory biomarkers of food intake	one day	Mangiferin and pyrogallol for mango, peseitol, mannoheptulosa for avocado, and opuntiol for nopal.

Trial Locations

Locations (1)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán; 🇲🇽 Mexico City, Mexico