Mangos to Reduce Cardiometabolic Risk Markers

Study Overview
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Brief Summary
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This research study will determine the effects of mango consumption on blood pressure, body weight, dietary nutrient/pattern changes, total cholesterol, LDL-cholesterol, VLDL-cholesterol, triglycerides, and HDL-cholesterol in individuals with moderately elevated blood pressure and/or LDL-cholesterol.

Detailed Description
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Cardiovascular disease (CVD) is the leading cause of death in the United States and worldwide. Risk factors for CVD include, obesity, high serum concentrations of low-density lipoprotein (LDL) cholesterol, very-low-density lipoprotein (VLDL) cholesterol, triglycerides, and total cholesterol, as well as low serum concentrations of high-density lipoprotein (HDL) cholesterol. Hypertension (high blood pressure) is an additional risk factor for CVD. Dietary strategies to reduce the risk for CVD include consuming adequate amounts of fruits, vegetables, and whole grains. However, there is limited published research regarding the effects of specific food items on CVD risk factors. One such example are mangos; there are murine studies, but there is a paucity of human clinical trial research on the effects of mango consumption on decreasing the risk factors for CVD. Therefore, the objective of this proposed study will examine whether mango consumption lowers these CVD risk factors in individuals with hypertension and/or dyslipidemia. The hypothesis is that mango consumption will decrease LDL-cholesterol, VLDL-cholesterol, triglycerides, total cholesterol, body weight, and blood pressure, and increase HDL-cholesterol. This proposed study will follow a randomized, controlled, cross-over design. Blood draws will be performed at baseline, after 8 weeks, and at the end of each dietary treatment, at the Student Health Services at California State Polytechnic University, Pomona. In addition, height, body weight, and blood pressure measurements will be taken. Subsequently, lipid panels will be generated for each participant, and those with dyslipidemia and/or hypertension will consume either 1 cup of mango or vanilla wafers (iso-caloric control) per day for 16 weeks. After a 4-week washout period, the subjects will consume the other dietary treatment for 16 weeks. Two-way repeated measures Analysis of Variance (ANOVA), followed by least significant difference (LSD) post-hoc analysis, will be used to determine if there are significant differences in CVD risk factors between the mango and wafer diets. Furthermore, the participants will complete two 24-hour recalls during the week before each laboratory visit. It is expected that the consumption of mangos will decrease LDL-cholesterol, VLDL-cholesterol, triglycerides, total cholesterol, body weight, and blood pressure, and increase HDL-cholesterol compared to the wafer diet. This proposed study will be the first to determine the cardiovascular health benefits of mango consumption in humans.

Official Title
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Mangos to Reduce Cardiometabolic Risk Markers

Conditions
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Healthy

Intervention / Treatment
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* Other: Mango
* Other: vanilla wafers


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Apparently healthy students (18 to 40 years) Attend California State Polytechnic University, Pomona Moderately elevated blood pressure (systolic greater than 120 mm Hg or diastolic greater than 80 mm Hg) and/or LDL-cholesterol (greater than 100 mg/dL) Exclusion Criteria: Smokers Pregnancy Any medical issues Allergies or dislike of mangos Allergies to wheat, milk, eggs, and/or soy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: The study will follow a randomized, controlled, crossover design with two 16-week dietary interventions separated by 4-week washout periods.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mango<br>The participants will consume one cup of fresh mango (100 kcal) per day for sixteen weeks. | Other: Mango<br>* The participants will consume the treatment for 16 weeks, followed by a 4-week washout period.<br>|
| Placebo Comparator: Wafer<br>The participants will consume vanilla wafers (100 kcal) per day for sixteen weeks. | Other: vanilla wafers<br>* vanilla wafers<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure (mm Hg) | Systolic and diastolic blood pressure will be measured. | 16 weeks for mango consumption and 16 weeks for vanilla wafer consumption | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight (kg) and height (cm) | Body weight, height, and body mass index (BMI) will be measured. | 16 weeks for mango consumption and 16 weeks for vanilla wafer consumption | 
| Blood lipids (mg/dL) | Total cholesterol, low-density lipoprotein cholesterol, very-low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and triglycerides will be measured. | 16 weeks for mango consumption and 16 weeks for vanilla wafer consumption | 
| Dietary analysis (six 24-hour dietary recalls per person in each treatment arm) | Dietary nutrient consumption will be measured (g or mg). | 16 weeks for mango consumption and 16 weeks for vanilla wafer consumption |