Mangos to Reduce Cardiometabolic Risk Markers

Sponsor
California State Polytechnic University, Pomona (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06029647
Collaborator
(none)
40
2
12

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Mango
  • Other: vanilla wafers
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
The study will follow a randomized, controlled, crossover design with two 16-week dietary interventions separated by 4-week washout periods.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)
Primary Purpose:
Basic Science
Official Title:
Mangos to Reduce Cardiometabolic Risk Markers
Anticipated Study Start Date :
Oct 2, 2023
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Oct 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Mango

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

Other: Mango
The participants will consume the treatment for 16 weeks, followed by a 4-week washout period.

Placebo Comparator: Wafer

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

Other: vanilla wafers
vanilla wafers

Outcome Measures

Primary Outcome Measures

  1. Blood pressure (mm Hg) [16 weeks for mango consumption and 16 weeks for vanilla wafer consumption]

    Systolic and diastolic blood pressure will be measured.

Secondary Outcome Measures

  1. Body weight (kg) and height (cm) [16 weeks for mango consumption and 16 weeks for vanilla wafer consumption]

    Body weight, height, and body mass index (BMI) will be measured.

  2. Blood lipids (mg/dL) [16 weeks for mango consumption and 16 weeks for vanilla wafer consumption]

    Total cholesterol, low-density lipoprotein cholesterol, very-low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and triglycerides will be measured.

  3. Dietary analysis (six 24-hour dietary recalls per person in each treatment arm) [16 weeks for mango consumption and 16 weeks for vanilla wafer consumption]

    Dietary nutrient consumption will be measured (g or mg).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • California State Polytechnic University, Pomona

Investigators

  • Principal Investigator: Erik Froyen, PhD, Cal Poly Pomona
  • Principal Investigator: Bonny Burns-Whitmore, DrPH, RD, Cal Poly Pomona

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Erik Froyen, PhD, Assistant Professor, California State Polytechnic University, Pomona
ClinicalTrials.gov Identifier:
NCT06029647
Other Study ID Numbers:
  • 603036
First Posted:
Sep 8, 2023
Last Update Posted:
Sep 11, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 11, 2023