Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Mango Board | OTHER |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mango Supplement | Experimental | Participants will consume 120g of fresh mango per day for 24 weeks |
|
| Placebo Matched Supplement | Placebo Comparator | Participants will consume 200g isocaloric granola bar per day for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mango | Other | 120g of fresh Mango |
| |
| Placebo |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Robert Hickner, Ph.D. | Florida State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida State University | Tallahassee | Florida | 32306 | United States |
Not provided
| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C501277 | Mangifera indica extract |
Not provided
Not provided
Not provided
Randomized, calorie-match controlled
Not provided
Not provided
None (Open Label)
Not provided
| Other |
200g isocaloric Granola Bar |
|
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
| 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 |
| D004700 | Endocrine System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |