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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06773078
Enrollment
92
Registered
2025-01-14
Start date
2024-07-01
Completion date
2024-12-01
Last updated
2025-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

dietary assessment, nutrimetabolomics, avocado, corn tortilla, nopal, guava, mango, amaranth

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.

Interventions

OTHERHigh 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).

OTHERAverage 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).

Sponsors

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Intervention model description

Randomized controlled, open-label trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 81 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Exploratory biomarkers of food intakeone dayMangiferin and pyrogallol for mango, peseitol, mannoheptulosa for avocado, and opuntiol for nopal.

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026