Cardiometabolic Health Indicators, Inflammation, Vascular Function in Healthy Volunteers
Conditions
Keywords
mango, cardiometabolic, adolescents, microbiome
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.
Interventions
OTHERAtaulfo mango
4 weeks of Ataulfo mango intake
Sponsors
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 19 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Microvascular Function | 4 weeks | Microvascular function as measured by peripheral arterial tonometry (ENDO PAT 2000) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cytokines | 4 weeks | Th17 cytokine panel |
| short chain fatty acids | 4 weeks | both plasma and fecal |
| Bile acids | 4 weeks | plasma bile acids |
| zonulin | 4 weeks | serum zonulin |
| 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) |
Countries
United States
Contacts
CONTACTRoberta R Holt, PhD
CONTACTGenesis G Guerra Gaitan, MS
PRINCIPAL_INVESTIGATORRoberta R Holt, PhD
University of California, Davis
Outcome results
None listed