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

NCT ID: NCT06773078

Last Updated: 2025-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2024-12-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

high intake group

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

Group Type: EXPERIMENTAL

High intake group

Intervention Type: OTHER

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).

Average intake group

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

Group Type: EXPERIMENTAL

Average intake group

Intervention Type: OTHER

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).

Interventions

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).

Intervention Type: 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).

Intervention Type: OTHER

Eligibility Criteria

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

• Were pregnant.
• Smoking habit durig the trial.
• Intake of alcoholic beverages during the trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 81 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

OTHER

Sponsor Role: lead

Responsible Party

Daniel Illescas Zárate

Doctorate in Science in Population Nutrition

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, , Mexico

Countries

Mexico

Other Identifiers

5113

Identifier Type: -

Identifier Source: org_study_id