Discovery of Biomarkers of Intake of of Highly Consumed Foods in Mexico
NCT ID: NCT06449170
Last Updated: 2024-06-07
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
NA
12 participants
INTERVENTIONAL
2023-01-01
2024-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
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
BASIC_SCIENCE
NONE
Study Groups
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Mango Ataulfo
150g of mango Ataulfo plus 150 ml of control beverage (Supportan® Drink Cappuccino) plus 15ml of sunflower seed oil
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.
Avocado Hass
120g of avocado hass plus 150ml of control beverage (Supportan® Drink Cappuccino)
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.
Boiled Nopal
300g of boiled nopal plus 150 ml of control beverage (Supportan® Drink Cappuccino) plus 18ml of sunflower seed oil
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.
Corn Tortilla
3 pieces of corn tortilla plus 150 ml of control beverage (Supportan® Drink Cappuccino) plus 2ml of sunflower seed oil
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.
Guava
3 pieces of guava plus 150 ml of control beverage (Supportan® Drink Cappuccino) plus 16ml of sunflower seed oil
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.
Amaranth
1/2 cup of amaranth plus 150 ml of control beverage (Supportan® Drink Cappuccino) plus 35ml of sunflower seed oil
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.
Supportan® DKN Cappuccino
290ml of control beverage (Supportan® Drink Cappuccino)
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.
Interventions
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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.
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.
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.
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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* Healthy males and females
* BMI \>18.5 and \< 25 kg/m2
* Willing/able to consume all test foods and the standardized meals
Exclusion Criteria
* 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
18 Years
40 Years
ALL
Yes
Sponsors
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Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
OTHER
Responsible Party
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Natalia Vázquez Manjarrez
Researcher in Medical Sciences
Principal Investigators
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Natalia Vázquez Manjarrez, PhD
Role: PRINCIPAL_INVESTIGATOR
National Institute of Medical Sciences and Nutrition Salvador Zubirán
Locations
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Instituto de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, , Mexico
Countries
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References
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Related Links
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The Food database
Other Identifiers
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4044
Identifier Type: -
Identifier Source: org_study_id
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