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Active, Not Recruiting

NCT Number: NCT06159543

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hyperglycemia Dyslipidemias Glucose Metabolism Disorders Hyperinsulinism Inflammation Insulin Resistance Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Oxidative Stress Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Loma Linda, California, 92350, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 or BMI 25-39 kg/m2

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 >39 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

Treatment and study plan

Mango

Behavioral

1.5 cups/day of mango for 12 weeks

Primary outcomes

  1. LDL-cholesterol

    Time frame: 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.

  2. Total cholesterol

    Time frame: 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.

  3. HDL-cholesterol

    Time frame: 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.

  4. Triglycerides

    Time frame: 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.

  5. HgbA1c

    Time frame: 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.

  6. Fasting blood glucose

    Time frame: 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.

  7. Fasting blood insulin

    Time frame: 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.

  8. HOMA-IR (Insulin resistance)

    Time frame: 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.

    Fasting blood glucose and fasting blood insulin will be used to quantify HOMA-IR values.

  9. Oxidized LDL-cholesterol

    Time frame: 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.

  10. 8-iso-PGF2 alpha

    Time frame: 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

  1. C-reactive protein

    Time frame: 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.

  2. E-selectin

    Time frame: 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.

  3. ICAM

    Time frame: 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.

  4. VCAM

    Time frame: 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.

  5. TNF-alpha

    Time frame: 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.

  6. IL-beta

    Time frame: 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.

  7. Percent body fat

    Time frame: Percent body fat will be measured at weeks 0, 4, 8, 12 of each phase of the study.

  8. Fat mass

    Time frame: Fat mass will be measured at weeks 0, 4, 8, 12 of each phase of the study.

  9. Lean body mass

    Time frame: Lean body mass will be measured at weeks 0, 4, 8, 12 of each phase of the study.

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Collaborators

  • National Mango Board

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Dec 6, 2023
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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