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

Study Overview
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Brief Summary
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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 and VCAM? 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 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, 12, and 28 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, 16, 20, 24, and 28 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.

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

Conditions
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Hyperglycemia, Dyslipidemias, Insulin Resistance, Inflammation, Oxidative Stress

Intervention / Treatment
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* Behavioral: Mango


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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, 12, and 28 of the study. | 
| Total cholesterol |  | Total cholesterol will be measured in fasting blood that will be drawn at weeks 0, 12, and 28 of the study. | 
| HDL-cholesterol |  | HDL-cholesterol will be measured in fasting blood that will be drawn at weeks 0, 12, and 28 of the study. | 
| Triglycerides |  | Triglycerides will be measured in fasting blood that will be drawn at weeks 0, 12, and 28 of the study. | 
| HgbA1c |  | HgbA1c will be measured in fasting blood that will be drawn at weeks 0, 12, and 28 of the study. | 
| Fasting blood glucose |  | Fasting blood glucose will be measured in fasting blood that will be drawn at weeks 0, 12, and 28 of the study. | 
| Fasting blood insulin |  | Fasting blood insulin will be measured in fasting blood that will be drawn at weeks 0, 12, and 28 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, 12, and 28 of the study, and used to quantify HOMA-IR values | 
| Oxidized LDL-cholesterol |  | Oxidized LDL-cholesterol will be measured in fasting blood that will be drawn at weeks 0, 12, and 28 of the study | 
| 8-iso-PGF2 alpha |  | 8-iso-PGF2 alpha will be measured in fasting blood that will be drawn at weeks 0, 12, and 28 of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-reactive protein |  | C-reactive protein will be measured in fasting blood that will be drawn at weeks 0, 12, and 28 of the study | 
| E-selectin |  | E-selectin will be measured in fasting blood that will be drawn at weeks 0, 12, and 28 of the study | 
| ICAM |  | ICAM will be measured in fasting blood that will be drawn at weeks 0, 12, and 28 of the study | 
| VCAM |  | VCAM will be measured in fasting blood that will be drawn at weeks 0, 12, and 28 of the study | 
| Percent body fat |  | Percent body fat will be measured at weeks 0, 4, 8, 12, 16, 20, 24, 28 | 
| Fat mass |  | Fat mass will be measured at weeks 0, 4, 8, 12, 16, 20, 24, 28 | 
| Lean body mass |  | Lean body mass will be measured at weeks 0, 4, 8, 12, 16, 20, 24, 28 |