Discovery of Biomarkers of Intake of of Highly Consumed Foods in Mexico (BIAMEX)

June 6, 2024 updated by: Natalia Vázquez Manjarrez, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

BIAMEX: Discovery of Biomarkers of Intake of Highly Consumed Foods in Mexico by Untargeted Metabolomics

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The BIAMEX study aims to address the challenge of improving the accuracy of dietary assessment, a critical factor in misunderstanding the relationship between diet and disease. Traditional dietary assessment tools, such as 24-hour recalls and food frequency questionnaires, are susceptible to biases related to their retrospective nature, such as memory errors and respondent burden. To overcome these limitations, BIAMEX focuses on discovering biomarkers on food intake (BFIs) for foods that originate in our country and are highly consumed by the population. This project will investigate the BFIs for nopal, corn tortilla, mango, avocado, guava, and amaranth.

This exploratory study employs a randomized, open, crossover, controlled design to investigate the metabolomic changes in urine and serum samples from healthy volunteers following the consumption of the selected foods. The interventions aim to assess the impact of each food intake on the metabolomic profile of the participants using an untargeted approach with liquid chromatography-mass spectrometry.

Participants were briefed at the Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán" on the study's aims, procedures, and benefits before providing informed consent. Subsequent steps included clinical history documentation and blood sampling for eligibility assessment, focusing on fasting glucose, cholesterol levels, and other health indicators. Volunteers underwent seven distinct food interventions in a randomized manner, including mango, avocado, nopal, corn tortillas, guavas, amaranth, and Supportan® drink Cappuccino as the control. This beverage was chosen to avoid metabolomic overlap with the different foods, ensuring distinct biomarker detection. Preceding the intervention days, subjects followed a low-polyphenol diet, excluding test foods and phytochemicals-rich items such as tea, coffee, or chocolate, culminating in a standardized dinner. On the intervention day, subjects arrived fasting at the institution and provided a baseline serum and urine samples. Then, subjects were provided with the test food, after which urine and serum samples were collected at 1h, 2h,4h, 6h postprandially on site. After the six-hour timepoint, the catheter was removed, and a standardized lunch was provided. Subjects continued to collect urine samples at home, corresponding to the 12h and 24h urine collection, using materials provided by the investigation team. Additionally, subjects received dietary instructions and menus to follow for the rest of the day. On the day after the intervention, subjects returned to the institution to deliver the urine collections and to provide the last serum sample corresponding to the 24-hour timepoint. Once the sample was collected, subjects were provided with a complimentary breakfast, and their habitual diet was resumed. This experimental procedure was repeated for each food separated by a 7-day wash-out period.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Ciudad de México, Mexico, 14080
        • Instituto de Ciencias Médicas y Nutrición Salvador Zubirán

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Signed informed consent
  • Healthy males and females
  • BMI >18.5 and < 25 kg/m2
  • Willing/able to consume all test foods and the standardized meals

Exclusion Criteria:

  • Smokers
  • Diagnosed health condition (chronic or infectious disease)
  • Taking nutritional supplements (e.g. vitamins, minerals) several times a week.
  • Taking medication.
  • Pregnant, lactating.
  • Antibiotics treatment within 3 months prior to intervention.
  • Vegetarians, as standardized meals will contain meat.
  • Not willing to follow nutritional restrictions, including drinking alcohol during study days
  • Allergic to foods of interest

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Mango Ataulfo
150g of mango Ataulfo plus 150 ml of control beverage (Supportan® Drink Cappuccino) plus 15ml of sunflower seed oil
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
120g of avocado hass plus 150ml of control beverage (Supportan® Drink Cappuccino)
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: Boiled Nopal
300g of boiled nopal plus 150 ml of control beverage (Supportan® Drink Cappuccino) plus 18ml of sunflower seed oil
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: Corn Tortilla
3 pieces of corn tortilla plus 150 ml of control beverage (Supportan® Drink Cappuccino) plus 2ml of sunflower seed oil
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
3 pieces of guava plus 150 ml of control beverage (Supportan® Drink Cappuccino) plus 16ml of sunflower seed oil
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
1/2 cup of amaranth plus 150 ml of control beverage (Supportan® Drink Cappuccino) plus 35ml of sunflower seed oil
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.
Other: Supportan® DKN Cappuccino
290ml of control beverage (Supportan® Drink Cappuccino)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metabolic profiling of urine samples after intake of mango, amaranth, nopal, corn tortilla, avocado, and guava, detected as mass-to-charge signals (cps) by an untargeted metabolomics approach over 24 hours post-intake.
Time Frame: Before intake of foods 00 hours to 24 hours after intake.
Given the absence of a priori knowledge of specific urinary biomarkers of intake for mango, nopal, amaranth, avocado, corn tortilla, and guava, an untargeted metabolomics approach will be employed to identify them. As an exploratory approach, this methodology will determine the myriad of signals (mass-to-charge ratios) present in urine samples, which correspond to metabolites that become bioavailable after the intake of the test foods, collected at 0-1, 1-2, 4-6, 6-12, and 12-24 hours after intake. The analysis of the patterns in the metabolome will facilitate the discovery of potential biomarkers of intake.
Before intake of foods 00 hours to 24 hours after intake.
Metabolic profiling of serum samples after intake of mango, amaranth, nopal, corn tortilla, avocado, and guava, detected as mass-to-charge signals (cps) by an untargeted metabolomics approach over 24 hours post-intake.
Time Frame: Before intake of foods 00 hours to 24 hours after intake.
Given the absence of a priori knowledge of specific serum biomarkers of intake for mango, nopal, amaranth, avocado, corn tortilla, and guava, an untargeted metabolomics approach will be employed to identify them. As an exploratory approach, this methodology will determine the myriad of signals (mass-to-charge ratios) present in serum samples collected at baseline, 1 hour, 2 hours, 4 hours, 6 hours, and 24 hours after the intake of. The analysis of the patterns in the metabolome will facilitate the discovery of potential biomarkers of intake.
Before intake of foods 00 hours to 24 hours after intake.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Investigators

  • Principal Investigator: Natalia Vázquez Manjarrez, PhD, National Institute of Medical Sciences and Nutrition Salvador Zubiran

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

April 5, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

May 22, 2024

First Submitted That Met QC Criteria

June 6, 2024

First Posted (Actual)

June 7, 2024

Study Record Updates

Last Update Posted (Actual)

June 7, 2024

Last Update Submitted That Met QC Criteria

June 6, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 4044

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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