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

NCT06159543 | Active Not Recruiting

• 1 other identifier: 5230515
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hyperglycemia; Dyslipidemias; Insulin Resistance; Inflammation; Oxidative Stress

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (9)

• 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.

Study Arms (2)

Mango added to habitual diet

EXPERIMENTAL

Participants will be asked to consume 1.5 cups of mango per day for 12 weeks as part of their habitual diet.

Behavioral: Mango

Habitual diet without mango

NO INTERVENTION

Participants will be asked to refrain consuming mangos for 12 weeks while continuing their habitual diet.

Interventions

Mango BEHAVIORAL

1.5 cups/day of mango for 12 weeks

Mango added to habitual diet

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loma Linda University: lead
• National Mango Board: collaborator

Study Sites (1)

Nutrition Research Center, School of Public Health, Loma Linda University

Loma Linda, California, 92350, United States

Location

MeSH Terms

Conditions

Hyperglycemia; Dyslipidemias; Insulin Resistance; Inflammation

Interventions

Mangifera indica extract

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Lipid Metabolism Disorders; Hyperinsulinism; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Celine Heskey, DrPH

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 6, 2023
• Study Start: July 30, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: October 6, 2025

Record last verified: 2025-09

Locations

US (1)