Optimizing Mango's Glycemic Impact: Investigating Mango Consumption Timing in Relation to Meal in Prediabetic Individuals
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 33
- 试验地点
- 3
- 主要终点
- Change in postprandial glucose
研究概览
简要总结
The purpose of this study is to investigate the effect of mango intake on metabolic and inflammatory responses relative to meals in individuals at risk of developing diabetes, as well as to understand how the beneficial compounds found in mangoes are absorbed and processed in the body.
详细描述
The primary goal of the proposed project is to advance current knowledge about the antidiabetic and anti-inflammatory benefits of consuming mangoes, especially in individuals with prediabetes, and to determine the best timing of mango intake relative to meals.
Participation in this study will last approximately five weeks and will include six visits: one screening visit lasting about one hour and four study-day visits, each lasting approximately eight hours. During these study visits, blood and urine samples will be collected to help researchers better understand the effects of mango intake relative to meal consumption.
Screening Visit:
Participant eligibility for the study is based on the inclusion and exclusion criteria. To assess this, the participant will need to arrive at the Clinical Nutrition Research Center (CNRC) fasting for 10-12 hours, meaning no food or drink other than plain water during this period.
During the screening visit, the following assessments will be conducted:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Single-blind
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be between 20-60 years old.
- •Have a BMI of 25-35 kilograms per square meter.
- •Have fasting blood glucose between 100-125 milligrams per deciliter or Glycated hemoglobin (HbA1c) between 5.7-6.4%.
- •Be non-smokers for at least 12 months.
- •Be generally healthy, with no major organ-related diseases.
- •Not take medications or supplements that could interfere with the study.
- •Be able to follow study procedures, including dietary restrictions and scheduled visits.
排除标准
- •Smoke, vape, or use marijuana.
- •Have allergies or intolerance to mangoes or study foods.
- •Have blood pressure above 160/100 millimeters of Mercury.
- •Have fasting blood glucose above 125 milligrams per deciliter.
- •Have a history of major heart disease, stroke, or cancer in the past five years.
- •Be pregnant, planning to become pregnant, or breastfeeding.
- •Take anti-inflammatory drugs or certain dietary supplements.
- •Have had major surgery or trauma in the past two months.
- •Follow extreme diets (e.g., vegan, Atkins).
- •Have used antibiotics in the last six weeks.
- •Have a history of eating disorders or substance abuse in the past two years.
- •Drink more than three cups of coffee or tea per day.
- •Have donated blood in the last three months.
- •Be professional athletes or do excessive exercise.
- •Have had weight changes of more than 11 pounds in the past two months.
- •Work overnight shifts.
研究组 & 干预措施
Mango Before Meal
1 cup (165 grams) of mango before standardized breakfast
干预措施: Mango (Other)
Mango With Meal
1 cup (165 grams) of mango with standardized breakfast
干预措施: Mango (Other)
Mango After Meal
1 cup (165 grams) of mango after standardized breakfast
干预措施: Mango (Other)
Control (no mango)
Control beverage (230 grams) with standardized breakfast
干预措施: Control Beverage (Other)
结局指标
主要结局
Change in postprandial glucose
时间窗: 7 hours
Change in postprandial glucose as measured by absolute values and calculated insulin sensitivity using homeostasis model assessment of fasting insulin sensitivity (HOMA-%S) and B-cell function (HOMA-%).
Change in postprandial glucose through peripheral insulin sensitivity
时间窗: 7 hours
Change in postprandial glucose as measured by assessment of peripheral insulin sensitivity using Matsuda index.
Change in postprandial insulin
时间窗: 7 hours
Change in postprandial insulin as measured by absolute values and calculated insulin sensitivity using homeostasis model assessment of fasting insulin sensitivity (HOMA-%S) and B-cell function (HOMA-%).
Change in postprandial insulin through peripheral insulin sensitivity
时间窗: 7 hours
Change in postprandial insulin as measured by assessment of peripheral insulin sensitivity using Matsuda index.
Evaluate Interleukin-6 (IL-6) as an index of systemic inflammatory response
时间窗: 7 hours
Assessments to address this aim will include analysis of systemic markers of inflammation (IL-6) in plasma using ELISA method
Evaluate Tumor Necrosis Factor-alpha (TNF-α) as an index of systemic inflammatory response
时间窗: 7 hours
Assessments to address this aim will include analysis of systemic markers of inflammation (TNF-α) in plasma using ELISA method
次要结局
- Characterize metabolite profiles(7 hours)