Cardiometabolic Health IndicatorsNCT07125001
Mango Intake and Gut and Cardiometabolic Health in Hispanic/Latino Adolescents
A study testing Ataulfo mango in people with Cardiometabolic Health Indicators and Vascular Function in Healthy Volunteers, run by University of California, Davis at 1 site in United States.
Trial summary
Mangos contain a number of nutrients that may improve gut and metabolic health. The purpose of this research is to see how eating mangos every day for 4 weeks instead of snacks high in calories and low in nutrients such as cookies, crackers, chips, and candy can impact adolescent health. Read more about this study
- Who is it for?
- Ages 12 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiometabolic Health Indicators, Vascular Function in Healthy Volunteers, Inflammation
- What is being tested?
- Ataulfo mango
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2025to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- - Male or Female 12-19 years old
- BMI ≥ 85th percentile (https://www.bcm.edu/bodycomplab/BMIapp/BMI-calculator-kids.html)
- Self-reported Hispanic/Latino
- Subject is willing and able to comply with the study protocols
- Subject is willing to consume the test products
- Female-specific criteria: if menstruating, eumenorrheic (regular monthly menstrual cycles of 25-30-days in length)
- Access to a smartphone or tablet at least 1x / day and willing to take pictures associated with the products to be consumed in the study
Who cannot join
- - Reported food allergies.
- Currently taking prescription drugs, with the exception of asthma inhalers, which are allowed
- BMI <85th percentile (https://www.bcm.edu/bodycomplab/BMIapp/BMI-calculator-kids.html)
- Current participation in a moderate or high-intensity daily exercise routine
- Self-reported disease, serious illness, or who are currently under acute medical care.
- Currently taking prescription drugs.
Show all 12Show fewer
- Any supplement use, including multi-vitamin/ mineral, herbal, plant or botanical, fish oil, and oil supplements, and not willing to discontinue before starting the study.
- Vegetarian or vegan diet
- Self-reported malabsorption or gastrointestinal issues
- Fruit and vegetable intake exceeding daily recommendations of 5 servings
- Smoking (vaping, conventional nicotine-containing products or marijuana)
- Current enrollee in a clinical research study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Genesis G Guerra Gaitan, MS contact
United States1 site, 1 recruiting
- Recruiting
Academic Surge; Ragle Human Nutrition Research Center
Davis, California, 95616
Roberta R Associate Researcher, PhD, 530-400-5952
California, 530-400-5952
About this study
Official title: The Influence of Mango-Derived Intestinal Microbial Metabolites on Gut Permeability, Inflammation, and Cardiometabolic Health Markers in Hispanic/Latino Adolescents
Mangos contain a number of nutrients that may improve gut and metabolic health. The purpose of this research is to see how eating mangos every day for 4 weeks instead of snacks high in calories and low in nutrients such as cookies, crackers, chips, and candy can impact adolescent health.
Read the detailed description
This study will record the functional and metabolic effects of daily mango intake, incorporated into the habitual diets of Hispanic/Latino adolescent children. This racial group is considered the most significant minority in the US, accounting for 19.1% of the population. The proposed study design allows for comparing baseline metabolic and physiological function to the real-world situation of adding a new snack food to a child in the major minority group in the US habitual diet. Moreover, the study design will allow the assessment of dietary changes in an understudied population at increased cardiovascular risk due to the high prevalence of overweight and obesity. Collectively, these analyses will help identify the complex relationships of mango-derived nutrients and microbial metabolites to physiologic response.
Twenty-five (12-19 years of age) adolescents will be enrolled in a randomized, controlled 2-arm crossover dietary intervention trial. Participants will be randomized to consume either ¾ cups of mango or continue their habitual diet for 4 weeks, followed by a 4-week washout period before crossing over to the alternate group. The mango flesh will be cut into uniform chunks (2-3 cm) and portioned into individual servings that can be consumed either as-is or blended into a smoothie.
- Being tested
- Ataulfo mango
- Keywords
- mango, cardiometabolic, adolescents, microbiome
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ataulfo mangoOther
4 weeks of Ataulfo mango intake
| Study group | Role | What they receive |
|---|---|---|
| Mango arm | Experimental | Ataulfo Mango intake Receives: Other: Ataulfo mango |
| No mango intake | No intervention | 4 weeks of no mango intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microvascular Function
Microvascular function as measured by peripheral arterial tonometry (ENDO PAT 2000)
Measured: 4 weeks
Secondary outcomes (9)
Cytokines
Th17 cytokine panel
Measured: 4 weeks
short chain fatty acids
both plasma and fecal
Measured: 4 weeks
Bile acids
plasma bile acids
Measured: 4 weeks
zonulin
serum zonulin
Measured: 4 weeks
soluble lipopolysaccharide binding protein
plasma
Measured: 4 weeks
cd14
plasma
Measured: 4 weeks
GLP-1
fasting plasma levels
Measured: 4 weeks
plasma lipids
total-, LDL-, HDL-cholesterol, and triglycerides
Measured: 4 weeks
IGF/IGFbp
insulin like growth factor (IGF) and its associated binding proteins (BP)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start1 Oct 2025
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiometabolic Health IndicatorsStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roberta R Holt, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07125001
- Sponsor's protocol ID
- 1939453
- Status last verified
- Jan 2026
- First submitted
- 7 Jul 2025
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Mango-Derived Intestinal Microbial Metabolites on Gut Permeability, Inflammation, and Cardiometabolic Health Markers in Hispanic/Latino Adolescents
- ClinicalTrials.gov ID
- NCT07125001
- Acronym / sponsor ID
- 1939453
- Keywords
- mango, cardiometabolic, adolescents, microbiome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 15 Aug 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.
Mangos contain a number of nutrients that may improve gut and metabolic health. The purpose of this research is to see how eating mangos every day for 4 weeks instead of snacks high in calories and low in nutrients such as cookies, crackers, chips, and candy can impact adolescent health.
Detailed description
This study will record the functional and metabolic effects of daily mango intake, incorporated into the habitual diets of Hispanic/Latino adolescent children. This racial group is considered the most significant minority in the US, accounting for 19.1% of the population. The proposed study design allows for comparing baseline metabolic and physiological function to the real-world situation of adding a new snack food to a child in the major minority group in the US habitual diet. Moreover, the study design will allow the assessment of dietary changes in an understudied population at increased cardiovascular risk due to the high prevalence of overweight and obesity. Collectively, these analyses will help identify the complex relationships of mango-derived nutrients and microbial metabolites to physiologic response.
Twenty-five (12-19 years of age) adolescents will be enrolled in a randomized, controlled 2-arm crossover dietary intervention trial. Participants will be randomized to consume either ¾ cups of mango or continue their habitual diet for 4 weeks, followed by a 4-week washout period before crossing over to the alternate group. The mango flesh will be cut into uniform chunks (2-3 cm) and portioned into individual servings that can be consumed either as-is or blended into a smoothie.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mango arm | Experimental | Other: Ataulfo mangoAtaulfo Mango intake |
| No mango intake | No intervention | –4 weeks of no mango intake |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- - Male or Female 12-19 years old
- BMI ≥ 85th percentile (https://www.bcm.edu/bodycomplab/BMIapp/BMI-calculator-kids.html)
- Self-reported Hispanic/Latino
- Subject is willing and able to comply with the study protocols
- Subject is willing to consume the test products
Key exclusion criteria (12 listed)
- - Reported food allergies.
- Currently taking prescription drugs, with the exception of asthma inhalers, which are allowed
- BMI <85th percentile (https://www.bcm.edu/bodycomplab/BMIapp/BMI-calculator-kids.html)
- Current participation in a moderate or high-intensity daily exercise routine
- Self-reported disease, serious illness, or who are currently under acute medical care.
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 |
|---|---|---|
| Ataulfo mango4 weeks of Ataulfo mango intake | Other | Mango arm |
Primary outcome
Microvascular Function
Time frame: 4 weeks
Microvascular function as measured by peripheral arterial tonometry (ENDO PAT 2000)
9 secondary outcomes
Cytokines
Time frame: 4 weeks
short chain fatty acids
Time frame: 4 weeks
Bile acids
Time frame: 4 weeks
zonulin
Time frame: 4 weeks
soluble lipopolysaccharide binding protein
Time frame: 4 weeks
cd14
Time frame: 4 weeks
GLP-1
Time frame: 4 weeks
plasma lipids
Time frame: 4 weeks
IGF/IGFbp
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Genesis G Guerra Gaitan, MS contact
Roberta R Holt, PhD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ataulfo mango in people with Cardiometabolic Health Indicators and Vascular Function in Healthy Volunteers, run by University of California, Davis at 1 site in United States.
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 7 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 3 Feb 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roberta R Holt, PhD (15304005952, rrholt@ucdavis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microvascular Function (time frame: 4 weeks). 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 3 Feb 2026.