NCT06773078

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran · Academic / Other
• Sex: All
• Age: 18 Years – 81 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
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).
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).

Timeline

• Start date: 2024-07-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2025-01-14
• Last updated: 2025-01-14

Locations

1 site across 1 country: Mexico