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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Effect of mango consumption on glycemic control evaluated by HOMA-IR
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
None (Open Label)
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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 %
排除标准
- •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.
结局指标
主要结局
Effect of mango consumption on glycemic control evaluated by HOMA-IR
时间窗: 3 years
HOMA-IR evaluated by blood draw 20 ml Enzyme-linked immunosorbent assay
Effect of mango consumption on glycemic control using blood glucose measures
时间窗: 3 years
Blood glucose measures evaluated with finger prick and blood glucose meter
Effect of mango consumption on glycemic control using HbA1c
时间窗: 3 years
HbA1c evaluated by finger prick and DCA analyzer
Effect of mango consumption on glycemic control evaluated by Insulin
时间窗: 3 years
Insulin evaluated by blood draw Enzyme-linked immunosorbent assay
Effect of mango consumption on glycemic control evaluated by HOMA-β
时间窗: 3 years
HOMA-β evaluated by blood draw 20 ml and Enzyme-linked immunosorbent assay
次要结局
- Effect of mango consumption on indicators of cardiovascular health evaluated by systolic and diastolic blood pressure(3 years)
- Atherogenic risk ratio (TC/HDL-C, LDLC/HDL-C, HDL-C/LDL-C)(3 years)
- Effect of mango consumption on body composition evaluated by phase angle (PA)(3 years)
- Effect of mango consumption on body composition evaluated by weight(3 years)
- Effect of mango consumption on anthropometric measure of HC(3 years)
- Effect of mango consumption on anthropometric measure WC/HC ratio(3 years)
- Effect of mango consumption on indicators of cardiovascular health evaluated by Indirect bioassay of in vivo endothelial function with PWV(3 years)
- Effect of mango consumption on indicators of cardiovascular health evaluated by Indirect bioassay of in vivo endothelial function with ET-1(3 years)
- Effect of mango consumption on indicators of cardiovascular health evaluated by biomarker of inflammation (C-reactive protein)(3 years)
- Effect of mango consumption on body composition evaluated by lean mass(3 years)
- Effect of mango consumption on body composition evaluated by fat mass(3 years)
- Effect of mango consumption on indicators of cardiovascular health evaluated by Indirect bioassay of in vivo endothelial function with FMD(3 years)
- Effect of mango consumption on indicators of cardiovascular health evaluated by lipid profile(3 years)
- Effect of mango consumption on anthropometric measure of Waist circumference (WC)(3 years)
研究者
Hickner
Principal Investigator
Florida State University