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

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Status: Completed

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

Treatments: Other: High intake group; Other: Average intake group

Study type: Interventional

Funder types: Other

Identifiers

NCT06773078

5113

Details and patient eligibility

About

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.

Full 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.

Enrollment: 92 patients

Sex: All

Ages: 18 to 81 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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92 participants in 2 patient groups

high intake group

Experimental group

Description:

Intake of meals containing the foods of interest avocado, corn tortilla, nopal, guava, mango, amaranth in the breakfast.

Treatment:

Other: High intake group

Average intake group

Experimental group

Description:

Intake of meals containing the foods of interest avocado, corn tortilla, nopal, guava, mango, amaranth in the breakfast.

Treatment:

Other: Average intake group