Nutrition, Biomarkers of Intake, Urinary Biomarkers, Foodomics, MetabolomNCT06773078
Validation of Urinary Biomarkers of Dietary Intake in Mexican Foods: a Randomize Controlled Trial
A study testing High intake group and Average intake group in people with Nutrition, Biomarkers of Intake, Urinary Biomarkers, Foodomics, Metabolom, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 81 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Biomarkers of Intake, Urinary Biomarkers, Foodomics, Metabolom
- What is being tested?
- High intake group and Average intake group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteMexico
- Study dates
- 1 Jul 2024to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 81 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- The exclusion criteria were participants with any other chronic disease diagnosed by any doctor.
- Were pregnant.
- Smoking habit durig the trial.
- Intake of alcoholic beverages during the trial.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, 14080
About this study
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.
Read the 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.
- Being tested
- High intake group, Average intake group
- Keywords
- dietary assessment, nutrimetabolomics, avocado, corn tortilla, nopal, guava, mango, amaranth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intake groupOther
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 groupOther
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).
| Study group | Role | What they receive |
|---|---|---|
| high intake group | Experimental | Intake of meals containing the foods of interest avocado, corn tortilla, nopal, guava, mango, amaranth in the breakfast. Receives: Other: High intake group |
| Average intake group | Experimental | Intake of meals containing the foods of interest avocado, corn tortilla, nopal, guava, mango, amaranth in the breakfast. Receives: Other: Average intake group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exploratory biomarkers of food intake
Mangiferin and pyrogallol for mango, peseitol, mannoheptulosa for avocado, and opuntiol for nopal.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start1 Jul 2024
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition, Biomarkers of Intake, Urinary Biomarkers, Foodomics, MetabolomStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled, open-label trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Illescas Zárate, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06773078
- Sponsor's protocol ID
- 5113
- Status last verified
- Jan 2025
- First submitted
- 8 Jan 2025
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Urinary Biomarkers of Dietary Intake in Mexican Foods: a Randomize Controlled Trial
- ClinicalTrials.gov ID
- NCT06773078
- Acronym / sponsor ID
- 5113
- Keywords
- dietary assessment, nutrimetabolomics, avocado, corn tortilla, nopal, guava, mango, amaranth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 14 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled, open-label trial
| Arm | Type | Receives |
|---|---|---|
| high intake group | Experimental | Other: High intake groupIntake of meals containing the foods of interest avocado, corn tortilla, nopal, guava, mango, amaranth in the breakfast. |
| Average intake group | Experimental | Other: Average intake groupIntake of meals containing the foods of interest avocado, corn tortilla, nopal, guava, mango, amaranth in the breakfast. |
Who may qualify
- Ages
- 18 to 81 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- The exclusion criteria were participants with any other chronic disease diagnosed by any doctor.
- Were pregnant.
- Smoking habit durig the trial.
- Intake of alcoholic beverages during the trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High intake groupIntake 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). | Other | high intake group |
| Average intake groupIntake 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). | Other | Average intake group |
Primary outcome
Exploratory biomarkers of food intake
Time frame: one day
Mangiferin and pyrogallol for mango, peseitol, mannoheptulosa for avocado, and opuntiol for nopal.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intake group and Average intake group in people with Nutrition, Biomarkers of Intake, Urinary Biomarkers, Foodomics, Metabolom, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exploratory biomarkers of food intake (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.