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Recruiting NCT07125001

Mango Intake and Gut and Cardiometabolic Health in Hispanic/Latino Adolescents

No phase Interventional Cardiometabolic Health Indicators Vascular Function in Healthy Volunteers Inflammation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ataulfo mango.
Who it may be relevant to
Registry conditions: Cardiometabolic Health Indicators, Vascular Function in Healthy Volunteers, Inflammation. Basic parameters: 12 years — 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Influence of Mango-Derived Intestinal Microbial Metabolites on Gut Permeability, Inflammation, and Cardiometabolic Health Markers in Hispanic/Latino Adolescents

Overview

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.

Interventions

  • Other Ataulfo mango
    4 weeks of Ataulfo mango intake

Primary outcome measures

  • Microvascular Function [Time frame: 4 weeks]
Secondary outcome measures (9)
  • 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]

Eligibility criteria

Inclusion criteria

  • \- 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

Exclusion criteria

  • \- 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.
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • Academic Surge; Ragle Human Nutrition Research Center — Davis

Identifiers

NCT: NCT07125001 · 1939453

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗