The Effects of Fresh Mango Consumption on Cardiometabolic Outcomes in Free-living Individuals With Prediabetes

The Effects of Fresh Mango Consumption on Cardiometabolic Outcomes in Free-living Individuals With Prediabetes: a Randomized Controlled Crossover Trial

The goal of this clinical trial is to test the effect of 12 weeks of 1.5 cups per day of fresh mango on glucose control, insulin resistance, lipids, inflammation, oxidation and body composition in individuals with prediabetes. The main questions it aims to answer are:

• What is the effect of 1.5 cups per day of fresh mango over 12 weeks on indicators of glycemic control including fasting glucose and HgbA1c?
• What is the effect of 1.5 cups per day of fresh mango over 12 weeks on fasting blood insulin and insulin resistance (HOMA-IR)?
• What is the effect of 1.5 cups per day of fresh mango over 12 weeks on lipids including LDL-cholesterol, total cholesterol, HDL-cholesterol and triglycerides?
• What is the effect of 1.5 cups per day of fresh mango over 12 weeks on oxidative stress including oxidized LDL-cholesterol and 8-iso-PGF2-alpha?
• What is the effect of 1.5 cups per day of fresh mango over 12 weeks on markers of inflammation including c-reactive protein, e-selectin, ICAM, VCAM, TNF-alpha and IL-beta?
• What is the effect of 1.5 cups per day of fresh mango over 12 weeks on percent body fat, fat mass, and lean mass?

Participants will be asked to:

• Consume 1.5 cups of mango per day for 12 weeks, take a 4 to 8 week break, and then avoid consuming mangos for 12 weeks
• Attend a prerandomization clinic prior to study
• Attend three (3) clinics where blood will be drawn during weeks 0, and 12 of the first phase and last week of the second phase of the study
• Attend eight (8) clinics where anthropometric measurements (height, weight, body composition) will be conducted and interaction with study clinicians will occur during weeks 0, 4, 8, 12 of each phase of the study
• Complete questionnaires and surveys in person and remotely, including six (6) 24-hour dietary recalls.

Researchers will compare the 12 weeks participants consume mango to the 12 weeks the participants are not consuming mango to see if there are differences in glycemic indicators, insulin resistance, lipids, inflammation, oxidation and body composition between the two time periods.

Study Overview

• Status: Active, not recruiting
• Conditions: Hyperglycemia; Inflammation; Insulin Resistance; Dyslipidemias; Oxidative Stress
• Intervention / Treatment: Behavioral: Mango

• Study Type: Interventional
• Enrollment (Estimated): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92350
      • Nutrition Research Center, School of Public Health, Loma Linda University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• HgbA1c of 5.7 to 6.4% indicative of prediabetes
• Abdominal obesity as defined as a waist circumference >102 cm for men or >88 cm for women

Exclusion Criteria:

• Self-reported chronic disease history (diabetes, heart disease, cancer, kidney disease, inflammatory bowel disease, etc.)
• Pacemaker
• Mango allergies
• Latex allergies (cross-reactive with mango)
• Smoking, use of tobacco, or high alcohol intake (>2 drinks/day for men or >1 drink per day for women)
• Recent significant weight loss (>5% within 6 months of study enrollment)
• BMI >35 kg/m^2
• Pregnancy or lactation
• Use of medication and/or supplements affecting glycemic indicators or lipids
• Habitual mango intake of >3 servings per week and/or habitual fruit intake of >2 servings per day
• Not able to read and/or communicate in English

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mango added to habitual diet; Participants will be asked to consume 1.5 cups of mango per day for 12 weeks as part of their habitual diet.	Behavioral: Mango; 1.5 cups/day of mango for 12 weeks
No Intervention: Habitual diet without mango; Participants will be asked to refrain consuming mangos for 12 weeks while continuing their habitual diet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LDL-cholesterol		LDL-cholesterol will be measured in fasting blood that will be drawn at weeks 0 and 12 of the first phase and the last week of the second phase of the study.
Total cholesterol		Total cholesterol will be measured in fasting blood that will be drawn at weeks 0 and 12 of the first phase and the last week of the second phase of the study.
HDL-cholesterol		HDL-cholesterol will be measured in fasting blood that will be drawn at weeks 0 and 12 of the first phase and the last week of the second phase of the study.
Triglycerides		Triglycerides will be measured in fasting blood that will be drawn at weeks 0 and 12 of the first phase and the last week of the second phase of the study.
HgbA1c		HgbA1c will be measured in fasting blood that will be drawn at weeks 0 and 12 of the first phase and the last week of the second phase of the study.
Fasting blood glucose		Fasting blood glucose will be measured in fasting blood that will be drawn at weeks 0 and 12 of the first phase and the last week of the second phase of the study.
Fasting blood insulin		Fasting blood insulin will be measured in fasting blood that will be drawn at weeks 0 and 12 of the first phase and the last week of the second phase of the study.
HOMA-IR (Insulin resistance)	Fasting blood glucose and fasting blood insulin will be used to quantify HOMA-IR values.	Fasting blood glucose and insulin will be measured in fasting blood that will be drawn at weeks 0 and 12 of the first phase and the last week of the second phase of the study.
Oxidized LDL-cholesterol		Oxidized LDL-cholesterol will be measured in fasting blood that will be drawn at weeks 0 and 12 of the first phase and the last week of the second phase of the study.
8-iso-PGF2 alpha		8-iso-PGF2 alpha will be measured in fasting blood that will be drawn at weeks 0 and 12 of the first phase and the last week of the second phase of the study.

Secondary Outcome Measures

Outcome Measure	Time Frame
C-reactive protein	C-reactive protein will be measured in fasting blood that will be drawn at weeks 0 and 12 of the first phase and the last week of the second phase of the study.
E-selectin	E-selectin will be measured in fasting blood that will be drawn at weeks 0 and 12 of the first phase and the last week of the second phase of the study.
ICAM	ICAM will be measured in fasting blood that will be drawn at weeks 0 and 12 of the first phase and the last week of the second phase of the study.
VCAM	VCAM will be measured in fasting blood that will be drawn at weeks 0 and 12 of the first phase and the last week of the second phase of the study.
TNF-alpha	TNF-alpha will be measured in fasting blood that will be drawn at weeks 0 and 12 of the first phase and the last week of the second phase of the study.
IL-beta	IL-beta will be measured in fasting blood that will be drawn at weeks 0 and 12 of the first phase and the last week of the second phase of the study.
Percent body fat	Percent body fat will be measured at weeks 0, 4, 8, 12 of each phase of the study.
Fat mass	Fat mass will be measured at weeks 0, 4, 8, 12 of each phase of the study.
Lean body mass	Lean body mass will be measured at weeks 0, 4, 8, 12 of each phase of the study.

Collaborators and Investigators

• Sponsor: Loma Linda University
• Collaborators: National Mango Board
• Investigators: Principal Investigator: Celine Heskey, DrPH, Loma Linda University

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: November 28, 2023
• First Submitted That Met QC Criteria: November 28, 2023
• First Posted (Actual): December 6, 2023

Study Record Updates

• Last Update Posted (Estimated): October 6, 2025
• Last Update Submitted That Met QC Criteria: September 30, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Glucose Metabolism Disorders; Hyperinsulinism; Lipid Metabolism Disorders; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Inflammation; Hyperglycemia; Insulin Resistance; Dyslipidemias; Mangifera indica extract
• Other Study ID Numbers: 5230515

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No