Clinical trial NCT06029647: Mangos to Reduce Cardiometabolic Risk Markers
Official title: Mangos to Reduce Cardiometabolic Risk Markers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: California State Polytechnic University, Pomona
Sponsor class: OTHER
First posted: 2023-09-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The study will follow a randomized, controlled, crossover design with two 16-week dietary interventions separated by 4-week washout periods.
Primary purpose: BASIC_SCIENCE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Blood pressure (mm Hg)
timeFrame: 16 weeks for mango consumption and 16 weeks for vanilla wafer consumption
Secondary outcomes:
measure: Body weight (kg) and height (cm)
timeFrame: 16 weeks for mango consumption and 16 weeks for vanilla wafer consumption
measure: Blood lipids (mg/dL)
timeFrame: 16 weeks for mango consumption and 16 weeks for vanilla wafer consumption
measure: Dietary analysis (six 24-hour dietary recalls per person in each treatment arm)
timeFrame: 16 weeks for mango consumption and 16 weeks for vanilla wafer consumption
Other outcomes:
Locations:
city: Pomona
country: United States
facility: California State Polytechnic University, Pomona
state: California
Study officials:
affiliation: Cal Poly Pomona
name: Erik Froyen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cal Poly Pomona
name: Bonny Burns-Whitmore, DrPH, RD
role: PRINCIPAL_INVESTIGATOR
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