The Effects of Fresh Mango Consumption on Cardiometabolic Outcomes in Free-living Individuals With Prediabetes: a Randomized Controlled Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Triglycerides
研究概览
简要总结
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, VCAM, TNF-alpha and IL-beta?
- 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 to 8 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, and 12 of the first phase and last week of the second phase 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 of each phase 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 or BMI 25-39 kg/m2
排除标准
- •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 >39 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
研究组 & 干预措施
Habitual diet without mango
Participants will be asked to refrain consuming mangos for 12 weeks while continuing their habitual diet.
Mango added to habitual diet
Participants will be asked to consume 1.5 cups of mango per day for 12 weeks as part of their habitual diet.
干预措施: Mango (Behavioral)
结局指标
主要结局
Triglycerides
时间窗: Triglycerides will be measured in fasting blood that will be drawn at weeks 0 and 12 of the first phase and the last week of the second phase of the study.
HgbA1c
时间窗: HgbA1c will be measured in fasting blood that will be drawn at weeks 0 and 12 of the first phase and the last week of the second phase of the study.
Fasting blood glucose
时间窗: Fasting blood glucose will be measured in fasting blood that will be drawn at weeks 0 and 12 of the first phase and the last week of the second phase of the study.
Total cholesterol
时间窗: Total cholesterol will be measured in fasting blood that will be drawn at weeks 0 and 12 of the first phase and the last week of the second phase of the study.
HOMA-IR (Insulin resistance)
时间窗: Fasting blood glucose and insulin will be measured in fasting blood that will be drawn at weeks 0 and 12 of the first phase and the last week of the second phase of the study.
Fasting blood glucose and fasting blood insulin will be used to quantify HOMA-IR values.
Oxidized LDL-cholesterol
时间窗: Oxidized LDL-cholesterol will be measured in fasting blood that will be drawn at weeks 0 and 12 of the first phase and the last week of the second phase of the study.
Fasting blood insulin
时间窗: Fasting blood insulin will be measured in fasting blood that will be drawn at weeks 0 and 12 of the first phase and the last week of the second phase of the study.
LDL-cholesterol
时间窗: LDL-cholesterol will be measured in fasting blood that will be drawn at weeks 0 and 12 of the first phase and the last week of the second phase of the study.
HDL-cholesterol
时间窗: HDL-cholesterol will be measured in fasting blood that will be drawn at weeks 0 and 12 of the first phase and the last week of the second phase of the study.
8-iso-PGF2 alpha
时间窗: 8-iso-PGF2 alpha will be measured in fasting blood that will be drawn at weeks 0 and 12 of the first phase and the last week of the second phase of the study.
次要结局
- C-reactive protein(C-reactive protein will be measured in fasting blood that will be drawn at weeks 0 and 12 of the first phase and the last week of the second phase of the study.)
- VCAM(VCAM will be measured in fasting blood that will be drawn at weeks 0 and 12 of the first phase and the last week of the second phase of the study.)
- IL-beta(IL-beta will be measured in fasting blood that will be drawn at weeks 0 and 12 of the first phase and the last week of the second phase of the study.)
- Percent body fat(Percent body fat will be measured at weeks 0, 4, 8, 12 of each phase of the study.)
- E-selectin(E-selectin will be measured in fasting blood that will be drawn at weeks 0 and 12 of the first phase and the last week of the second phase of the study.)
- TNF-alpha(TNF-alpha will be measured in fasting blood that will be drawn at weeks 0 and 12 of the first phase and the last week of the second phase of the study.)
- ICAM(ICAM will be measured in fasting blood that will be drawn at weeks 0 and 12 of the first phase and the last week of the second phase of the study.)
- Fat mass(Fat mass will be measured at weeks 0, 4, 8, 12 of each phase of the study.)
- Lean body mass(Lean body mass will be measured at weeks 0, 4, 8, 12 of each phase of the study.)