Effect of Mango Consumption on Individuals With Pre-diabetes

Study Overview
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Brief Summary
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This study is designed to explore the effect of mango consumption on glycemic indices, cardiovascular health, and body composition in overweight and obese individuals with prediabetes.

Detailed Description
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According to the Centers for Disease Control and Prevention (2016), at least 100 million adults in the United States are diagnosed as pre-diabetic or Type 2 diabetic. With the number of cases steadily increasing in this population, healthcare costs have subsequently increased for both the patient and the health care system. To date, there are few studies (limited to animal model and obese Type 2 diabetic humans) that have examined the efficacy of mangoes on health outcomes, particularly related to diabetes. Therefore, the purpose of the current study is to examine the effect of fresh mango on glycemic indices, body composition, and vascular health measures. Upon favorable outcomes, and with more definite evidence from human studies, mangoes can potentially be implemented in America's diet to help mitigate the advancement and diagnoses of pre and Type 2 diabetes and, as a result, aid in a reduction of healthcare costs. The current study is a 24- week, randomized, controlled experiment including 40 overweight or obese, pre-diabetic men and post-menopausal women aged 50 to 70 years with no diagnosed cardiovascular, metabolic, kidney, or other types of chronic disease to be included. Participants will be randomly assigned to one of two groups: 1) one fresh Tommy Atkins mango (120 g) per day or 2) an isocaloric granola bar per day for 24 weeks. Visits will include anthropometric measurements, glucose, and A1C values via finger prick, venous blood samples to analyze biomarkers related to glycemic control and lipid profiles, vascular measures, and body composition. To analyze the effects of the treatment, ANOVA and Bonferroni's test will be utilized. The investigators hypothesize that daily consumption of one mango per day for 24 weeks will improve the indices of glycemic control, cardiovascular health, and body composition in overweight and obese individuals with prediabetes.

Official Title
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The Effects of Fresh Mango Consumption in Indices of Glycemic Control, Cardiovascular Health, and Body Composition in Normal Weight, Overweight and Obese Individuals With Prediabetes

Conditions
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PreDiabetes, Obesity

Intervention / Treatment
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* Other: Mango
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Free of any chronic diseases such as cancer BMI of 18.5 kg/m2 to 34.9 kg/m2 wHbA1c values are 100 mg/dl to 125 mg/dl and HbA1C of 5.7-6.4 % Exclusion Criteria: Individuals diagnosed with cardiovascular diseases (CVD), type 2-diabetes, type 1 diabetes mellitus, other active chronic diseases such as cancer, asthma, glaucoma, kidney, liver and pancreatic disease Uncontrolled hypertension (≥160/100 mmHg) BMI <18.5 kg/m2 or >34.9 kg/m2 Not post-menopausal or have been taking hormone replacement therapy for less than 3 months taking more than one anti-hypertensive or have been taking them for less than 3 months Participating in a weight loss program or having lost or gain ≥10% bodyweight within the last 6 months Smoke more than 1 pack/day Consumption of >12 alcoholic drinks/week Frequent mango consumers (>5 servings/2weeks) In concurrent participation with another investigational study Currently consuming any performance supplement (i.e. creatine, nitric oxide, whey/casein protein, branched chain amino acids). None of the following special populations will be included: adults unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, or prisoners.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, calorie-match controlled
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mango Supplement<br>Participants will consume 120g of fresh mango per day for 24 weeks | Other: Mango<br>* 120g of fresh Mango<br>|
| Placebo Comparator: Placebo Matched Supplement<br>Participants will consume 200g isocaloric granola bar per day for 24 weeks | Other: Placebo<br>* 200g isocaloric Granola Bar<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of mango consumption on glycemic control using blood glucose measures | Blood glucose measures evaluated with finger prick and blood glucose meter | 3 years | 
| Effect of mango consumption on glycemic control using HbA1c | HbA1c evaluated by finger prick and DCA analyzer | 3 years | 
| Effect of mango consumption on glycemic control evaluated by Insulin | Insulin evaluated by blood draw Enzyme-linked immunosorbent assay | 3 years | 
| Effect of mango consumption on glycemic control evaluated by HOMA-IR | HOMA-IR evaluated by blood draw 20 ml Enzyme-linked immunosorbent assay | 3 years | 
| Effect of mango consumption on glycemic control evaluated by HOMA-β | HOMA-β evaluated by blood draw 20 ml and Enzyme-linked immunosorbent assay | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of mango consumption on indicators of cardiovascular health evaluated by systolic and diastolic blood pressure | Systolic and diastolic blood pressure evaluated by automated blood pressure monitor | 3 years | 
| Effect of mango consumption on indicators of cardiovascular health evaluated by Indirect bioassay of in vivo endothelial function with FMD | Flow-mediated dilation (FMD) evaluated with high-resolution doppler ultrasound (HD11XE, Phillips Ultrasound, Bothwell, WA, USA) with a 3-12 MHz linear array transducer | 3 years | 
| Effect of mango consumption on indicators of cardiovascular health evaluated by Indirect bioassay of in vivo endothelial function with PWV | Pulse wave velocity (PWV) evaluated with Sphygmocor for pulse wave velocity, aortic blood pressure and augmentation index | 3 years | 
| Effect of mango consumption on indicators of cardiovascular health evaluated by Indirect bioassay of in vivo endothelial function with ET-1 | Endothelin-1 (ET-1) evaluated with Enzyme-linked immunosorbent assay | 3 years | 
| Effect of mango consumption on indicators of cardiovascular health evaluated by biomarker of inflammation (C-reactive protein) | biomarker of inflammation (C-reactive protein) evaluated by blood draw 20 ml and enzyme-linked immunosorbent assay | 3 years | 
| Effect of mango consumption on indicators of cardiovascular health evaluated by lipid profile | lipid profile evaluated by blood draw and enzyme-linked immunosorbent assay consisting of Triglycerides (TG) Total cholesterol (TC) Low-density lipoprotein cholesterol (LDL-C) Oxidized LDL (Ox-LDL) High-density lipoprotein cholesterol (HDL-C) | 3 years | 
| Atherogenic risk ratio (TC/HDL-C, LDLC/HDL-C, HDL-C/LDL-C) | Effect of mango consumption on indicators of cardiovascular health evaluated by lipid profile | 3 years | 
| Effect of mango consumption on body composition evaluated by lean mass | Lean mass evaluated by bioimpedance spectroscopy (BIS) | 3 years | 
| Effect of mango consumption on body composition evaluated by fat mass | fat mass evaluated by bioimpedance spectroscopy (BIS) | 3 years | 
| Effect of mango consumption on body composition evaluated by phase angle (PA) | Phase angle (PA) calculated directly from reactance and resistance using the following formula: PA=arctangent reactance(ohm)/resistance (ohm) ×180°/π | 3 years | 
| Effect of mango consumption on body composition evaluated by weight | Weight evaluated by Ohaus Portable Electronic CS Series Scales | 3 years | 
| Effect of mango consumption on anthropometric measure of Waist circumference (WC) | evaluated by Gulick fiberglass measuring tape with a tension handle | 3 years | 
| Effect of mango consumption on anthropometric measure of HC | hip circumference (HC) evaluated by Gulick fiberglass measuring tape with a tension handle | 3 years | 
| Effect of mango consumption on anthropometric measure WC/HC ratio | waist to hip ratio (WC/HC) | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glycemic Control, Cardiovascular Health, Overweight, Obese, Glycemic Indices, Body Composition