Discovery of Biomarkers of Intake of of Highly Consumed Foods in Mexico

NCT06449170 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-06-07

No results posted yet for this study

Summary

To determine diet-health associations, researchers rely on information obtained from dietary instruments, such as the 24-hour recall (R24H), food frequency questionnaires (FFQ) and food diaries, in clinical studies. However, it is widely recognized that the information provided by the different instruments is biased by different factors including recall errors and respondent burden. The impact of the variability produced by this bias decreases the robustness of diet-health associations which results in the creation of less efficient standards and recommendations for our population. To address this, the discovery of biomarkers of food intake (BFIs) is an objective tool that indicates exposure to specific foods or various dietary patterns. BFIs allow the calibration of dietary information to obtain the real consumption of the individual and thus clarify the relationship between different pathologies of interest and the intake of different foods. BIAMEX will initially focus on the discovery of BFIs of nopal, corn tortilla, mango, avocado, guava and amaranth. For this purpose, a controlled crossover intervention study is being carried out with the 6 foods to be investigated where 24h urine and plasma samples are being collected. Subsequently, the samples collected will be analyzed by mass spectrometry.

Conditions

  • Nutrition, Healthy
  • Diet Habit
  • Diet, Healthy
  • Dietary Exposure

Interventions

OTHER

Mango Ataulfo

In this intervention, subjects consumed 150g of mango Ataulfo plus 150 ml of control beverage (Supportan® Drink Cappuccino). The addition of the control beverage has the purpose of providing energy intake and limiting the noise that the control beverage may contribute to the metabolomic profile in urine and serum.

OTHER

Avocado Hass

In this intervention, subjects consumed 120g of avocado hass plus 150 ml of a control beverage (Supportan® Drink Cappuccino). The addition of the control beverage provides energy intake and limits the noise that the beverage may contribute to the metabolomic profile in urine and serum.

OTHER

Nopal

In this intervention, subjects consumed 300g of cooked nopal and 150 ml of control beverage (Supportan® Drink Cappuccino). The addition of the control beverage provides energy intake and limits the noise that the beverage may contribute to the metabolic profile in urine and serum.

OTHER

3 corn tortilla

In this intervention, subjects consumed 3 corn tortillas and 150 ml of control beverage (Supportan® Drink Cappuccino). The addition of the control beverage provides energy intake and limits the noise that the beverage may contribute to the metabolic profile in urine and serum.

OTHER

Guava

In this intervention, subjects consumed 3 guavas and 150 ml of control beverage (Supportan® Drink Cappuccino). The addition of the control beverage provides energy intake and limits the noise that the beverage may contribute to the metabolic profile in urine and serum.

OTHER

Amaranth

In this intervention, subjects consumed 1/2 cup of amaranth and 150 ml of control beverage (Supportan® Drink Cappuccino). The addition of the control beverage provides energy intake and limits the noise that the beverage may contribute to the metabolic profile in urine and serum.

DIETARY_SUPPLEMENT

Control Beverage (Supportan Drink ® Capuccino)

In this intervention, subjects consumed 290ml of Supportan Drink ® Capuccino to act as a control for the metabolomic profiling in urine and serum.

Sponsors & Collaborators

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    lead OTHER

Principal Investigators

  • Natalia Vázquez Manjarrez, PhD · National Institute of Medical Sciences and Nutrition Salvador Zubirán

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2024-04-05
Completion
2024-12-31

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06449170 on ClinicalTrials.gov