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临床试验/NCT06029647
NCT06029647已完成不适用

Mangos to Reduce Cardiometabolic Risk Markers

California State Polytechnic University, Pomona2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年9月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
Blood pressure (mm Hg)

研究概览

简要总结

This research study will determine the effects of mango consumption on blood pressure, body weight, dietary nutrient/pattern changes, total cholesterol, LDL-cholesterol, VLDL-cholesterol, triglycerides, and HDL-cholesterol in individuals with moderately elevated blood pressure and/or LDL-cholesterol.

详细描述

Cardiovascular disease (CVD) is the leading cause of death in the United States and worldwide. Risk factors for CVD include, obesity, high serum concentrations of low-density lipoprotein (LDL) cholesterol, very-low-density lipoprotein (VLDL) cholesterol, triglycerides, and total cholesterol, as well as low serum concentrations of high-density lipoprotein (HDL) cholesterol. Hypertension (high blood pressure) is an additional risk factor for CVD. Dietary strategies to reduce the risk for CVD include consuming adequate amounts of fruits, vegetables, and whole grains. However, there is limited published research regarding the effects of specific food items on CVD risk factors. One such example are mangos; there are murine studies, but there is a paucity of human clinical trial research on the effects of mango consumption on decreasing the risk factors for CVD. Therefore, the objective of this proposed study will examine whether mango consumption lowers these CVD risk factors in individuals with hypertension and/or dyslipidemia. The hypothesis is that mango consumption will decrease LDL-cholesterol, VLDL-cholesterol, triglycerides, total cholesterol, body weight, and blood pressure, and increase HDL-cholesterol. This proposed study will follow a randomized, controlled, cross-over design. Blood draws will be performed at baseline, after 8 weeks, and at the end of each dietary treatment, at the Student Health Services at California State Polytechnic University, Pomona. In addition, height, body weight, and blood pressure measurements will be taken. Subsequently, lipid panels will be generated for each participant, and those with dyslipidemia and/or hypertension will consume either 1 cup of mango or vanilla wafers (iso-caloric control) per day for 16 weeks. After a 4-week washout period, the subjects will consume the other dietary treatment for 16 weeks. Two-way repeated measures Analysis of Variance (ANOVA), followed by least significant difference (LSD) post-hoc analysis, will be used to determine if there are significant differences in CVD risk factors between the mango and wafer diets. Furthermore, the participants will complete two 24-hour recalls during the week before each laboratory visit. It is expected that the consumption of mangos will decrease LDL-cholesterol, VLDL-cholesterol, triglycerides, total cholesterol, body weight, and blood pressure, and increase HDL-cholesterol compared to the wafer diet. This proposed study will be the first to determine the cardiovascular health benefits of mango consumption in humans.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Apparently healthy students (18 to 40 years)
  • Attend California State Polytechnic University, Pomona
  • Moderately elevated blood pressure (systolic greater than 120 mm Hg or diastolic greater than 80 mm Hg) and/or LDL-cholesterol (greater than 100 mg/dL)

排除标准

  • Pregnancy
  • Any medical issues
  • Allergies or dislike of mangos
  • Allergies to wheat, milk, eggs, and/or soy

结局指标

主要结局

Blood pressure (mm Hg)

时间窗: 16 weeks for mango consumption and 16 weeks for vanilla wafer consumption

Systolic and diastolic blood pressure will be measured.

次要结局

  • Blood lipids (mg/dL)(16 weeks for mango consumption and 16 weeks for vanilla wafer consumption)
  • Dietary analysis (six 24-hour dietary recalls per person in each treatment arm)(16 weeks for mango consumption and 16 weeks for vanilla wafer consumption)
  • Body weight (kg) and height (cm)(16 weeks for mango consumption and 16 weeks for vanilla wafer consumption)

研究者

发起方
California State Polytechnic University, Pomona
申办方类型
Other
责任方
Principal Investigator
主要研究者

Erik Froyen, PhD

Assistant Professor

California State Polytechnic University, Pomona

研究点 (2)

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