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

NCT06449170 | Active Not Recruiting

• 1 other identifier: 4044
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

metabolomics; nutrition; dietary biomarkers; dietary exposure

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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.

Study Arms (7)

Mango Ataulfo

OTHER

150g of mango Ataulfo plus 150 ml of control beverage (Supportan® Drink Cappuccino) plus 15ml of sunflower seed oil

Other: Mango Ataulfo

Avocado Hass

OTHER

120g of avocado hass plus 150ml of control beverage (Supportan® Drink Cappuccino)

Other: Avocado Hass

Boiled Nopal

OTHER

300g of boiled nopal plus 150 ml of control beverage (Supportan® Drink Cappuccino) plus 18ml of sunflower seed oil

Other: Nopal

Corn Tortilla

OTHER

3 pieces of corn tortilla plus 150 ml of control beverage (Supportan® Drink Cappuccino) plus 2ml of sunflower seed oil

Other: 3 corn tortilla

Guava

OTHER

3 pieces of guava plus 150 ml of control beverage (Supportan® Drink Cappuccino) plus 16ml of sunflower seed oil

Other: Guava

Amaranth

OTHER

1/2 cup of amaranth plus 150 ml of control beverage (Supportan® Drink Cappuccino) plus 35ml of sunflower seed oil

Other: Amaranth

Supportan® DKN Cappuccino

OTHER

290ml of control beverage (Supportan® Drink Cappuccino)

Dietary Supplement: Control Beverage (Supportan Drink ® Capuccino)

Interventions

Mango Ataulfo OTHER

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.

Mango Ataulfo

Avocado Hass OTHER

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.

Avocado Hass

Nopal OTHER

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.

Boiled Nopal

3 corn tortilla OTHER

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.

Corn Tortilla

Guava OTHER

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.

Guava

Amaranth OTHER

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.

Amaranth

Control Beverage (Supportan Drink ® Capuccino) DIETARY_SUPPLEMENT

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

Supportan® DKN Cappuccino

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead

Study Sites (1)

Instituto de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, 14080, Mexico

Location

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Related Links

• The Food database

MeSH Terms

Conditions

Feeding Behavior

Interventions

Amaranth Dye

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Intervention Hierarchy (Ancestors)

Azo Compounds; Organic Chemicals; Naphthalenesulfonates; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Polycyclic Compounds

Study Officials

• Natalia Vázquez Manjarrez, PhD

  National Institute of Medical Sciences and Nutrition Salvador Zubirán

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher in Medical Sciences

Model Details: This is a randomized, open, crossover, and controlled design study. A total of 12 healthy subjects (six males and six females) aged 18-40 years with a BMI of 18.5-24.9 kg/m\^2 were recruited. Participants underwent seven interventions (each featuring one of the selected foods or a control beverage), with a washout period of 7 days between interventions. Each intervention is as follows: 150g of mango + 150ml of control beverage, 120g of avocado + 150ml of control beverage, 300g of cooked nopal + 150ml of control beverage, 3 corn tortillas + 150ml of control beverage, 3 guavas + 150ml of control beverage, ½ cup of amaranth + 150ml of control beverage, 290ml of control beverage

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: June 7, 2024
• Study Start: January 1, 2023
• Primary Completion: April 5, 2024
• Study Completion: December 31, 2024
• Last Updated: June 7, 2024

Record last verified: 2024-06

Locations

ME (1)