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

Not Applicable

Not yet recruiting

• Conditions: Cardiometabolic Health Indicators; Vascular Function in Healthy Volunteers; Inflammation

• Registration Number: NCT07125001
• Lead Sponsor: University of California, Davis

Brief 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.

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 Timeline

• Study First Submitted: 2025-07-07
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-14
• Last Update Submitted: 2025-08-14
• Study Start: 2025-08-15
• Study First Posted: 2025-08-15
• Last Update Posted: 2025-08-15
• Primary Completion: 2028-03-31
• Study Completion: 2028-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Microvascular Function	4 weeks	Microvascular function as measured by peripheral arterial tonometry (ENDO PAT 2000)

Secondary Outcome Measures

Name	Time	Method
Bile acids	4 weeks	plasma bile acids
zonulin	4 weeks	serum zonulin
Cytokines	4 weeks	Th17 cytokine panel
short chain fatty acids	4 weeks	both plasma and fecal
soluble lipopolysaccharide binding protein	4 weeks	plasma
cd14	4 weeks	plasma
GLP-1	4 weeks	fasting plasma levels
plasma lipids	4 weeks	total-, LDL-, HDL-cholesterol, and triglycerides
IGF/IGFbp	4 weeks	insulin like growth factor (IGF) and its associated binding proteins (BP)