Mangos to Reduce Cardiometabolic Risk Markers

February 11, 2025 updated by: Erik Froyen, PhD, California State Polytechnic University, Pomona
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Pomona, California, United States, 91768
        • California State Polytechnic University, Pomona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure (mm Hg)
Time Frame: 16 weeks for mango consumption and 16 weeks for vanilla wafer consumption
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)
Time Frame: 16 weeks for mango consumption and 16 weeks for vanilla wafer consumption
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)
Time Frame: 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.
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)
Time Frame: 16 weeks for mango consumption and 16 weeks for vanilla wafer consumption
Dietary nutrient consumption will be measured (g or mg).
16 weeks for mango consumption and 16 weeks for vanilla wafer consumption

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

California State Polytechnic University, Pomona

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2023

Primary Completion (Actual)

September 12, 2024

Study Completion (Actual)

September 12, 2024

Study Registration Dates

First Submitted

August 26, 2023

First Submitted That Met QC Criteria

September 1, 2023

First Posted (Actual)

September 8, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 11, 2025

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 603036

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We do not plan to share the data with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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