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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
California State Polytechnic University, Pomona

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 18, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 12, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 12, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 26, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 8, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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