Mangos to Reduce Cardiometabolic Risk Markers

California State Polytechnic University, Pomona

Status: Completed

Conditions: Healthy

Treatments: Other: Mango; Other: vanilla wafers

Study type: Interventional

Funder types: Other

Identifiers

NCT06029647

603036

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups, including a placebo group

Mango

Experimental group

Description:

The participants will consume one cup of fresh mango (100 kcal) per day for sixteen weeks.

Treatment:

Other: Mango

Wafer

Placebo Comparator group

Description:

The participants will consume vanilla wafers (100 kcal) per day for sixteen weeks.

Treatment:

Other: vanilla wafers