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临床试验/NCT06318377
NCT06318377已完成不适用

Peanuts and Neurocognitive / Cardiovascular Health in Black Individuals

The University of Texas at Arlington2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Endothelial Function

研究概览

简要总结

The overall research objective of this proposal is to determine the impact of increased daily peanut consumption on indices of neurocognitive and physiological health in BL individuals

详细描述

Cardiovascular disease (CVD) is the leading cause of morbidity and mortality and affects all individuals; however, its prevalence is highest in the non-Hispanic Black (BL) population. This racial disparity is present in the primary risk factors for CVD, including hypertension, atherosclerosis, and type 2 diabetes mellitus. Furthermore, this population has the highest prevalence of various neurocognitive conditions and cerebral vascular diseases including cognitive dysfunction, dementia, stroke, and Alzheimer's disease. While the association between the BL population, neurocognitive complications/cerebral vascular diseases, and CVD is multifactorial, a common link in other populations is impaired vascular function. Indeed, vascular dysfunction.

A hallmark of impaired vascular function is elevated arterial stiffness, a decrease in the vasodilator capacity, and/or heightened sympathetic vascular transduction (i.e. vasoconstrictor response and increase in peripheral vascular resistance and arterial blood pressure to efferent sympathetic neural outflow). BL individuals have impaired endothelial function evidenced by a blunted vasodilatory response to a variety of stimuli. Reduced nitric oxide (NO) bioavailability, due to elevated oxidative stress, systemic inflammation and reduced L-arginine bioavailability, is implicated as a primary contributing factor for these attenuated vasodilatory responses. Therefore, it is reasonable to speculate that an intervention targeting these pathways could abolish or minimize this elevated risk. One such intervention could be increased dietary peanut consumption which has a beneficial effect on physiological outcomes associated with neurocognitive conditions, as well as cerebral vascular and CVD risk including, cholesterol, lipid profile, insulin sensitivity / type II diabetes, cognitive health, arterial stiffness, blood pressure, and NO bioavailability and subsequently vascular function / health. However, to our knowledge the effect of increased peanut consumption on neurocognitive and CVD risk factors in the BL population remains unknown.

Therefore, the overall research objective is of this proposal is to determine the impact of increased daily peanut consumption on indices of neurocognitive and physiological health in BL individuals. The following objectives / aims will be explored:

  1. Primary Aim - The primary endpoint is the effect of increased daily peanut consumption on outcomes associated with elevated risk for various neurocognitive and pathophysiological conditions/diseases. These outcomes include cognitive function, central and peripheral arterial blood pressure, cerebral and peripheral blood vessel function/health, autonomic function - i.e. vasoconstrictor responsiveness to efferent sympathetic neural outflow (sympathetic vascular transduction), and blood biomarkers (e.g., indices of inflammation, oxidative stress, insulin resistance/diabetes risk, and lipid profile).
  2. Secondary Aim - A secondary endpoint is the effect of daily peanut consumption on the following variables: body composition, body weight, and body mass index (BMI).
  3. Tertiary Aim - A tertiary endpoint is to examine the relationship between the various indices of physiological health with measures of Social Determinants of Health that are well known to influence the physiological outcomes that are being measured.

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
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals that self-identify as white or black and who have at least one biological parent who identifies as their own self-identified race/ethnicity will be included in this study. Both men and women will be included in this study. Individuals must be between the ages of 18-50.

排除标准

  • Individuals who have donated more than 550 ml of blood within the past 8 weeks will not have blood drawn from them in this protocol. However, if they remain interested in the study, and otherwise meet the inclusion criteria, then we may still opt to proceed with data collection.
  • Individuals with peanut allergy
  • Individuals in hypertensive crisis
  • Pregnant women
  • Breast feeding
  • Allergies to spandex/lycra

结局指标

主要结局

Endothelial Function

时间窗: baseline & following 8 weeks of daily peanut consumption

Flow medicated dilation of the brachial artery

Mean blood pressure in brachial artery (mmHg)

时间窗: baseline & following 8 weeks of daily peanut consumption

standard blood pressure measures 9(mmHg)

Diastolic blood pressure in brachial artery(mmHg)

时间窗: baseline & following 8 weeks of daily peanut consumption

standard blood pressure measures

Plasma concentration of High density lipoprotein (HDL)

时间窗: baseline & following 8 weeks of daily peanut consumption

assessment of High density lipoprotein (HDL)

Plasma concentration of total Cholesterol (Total-C)

时间窗: baseline & following 8 weeks of daily peanut consumption

assessment of total Cholesterol (Total-C)

Plasma concentration of Low density lipoprotein (LDL)

时间窗: baseline & following 8 weeks of daily peanut consumption

assessment of Low density lipoprotein (LDL)

Plasma concentration of Very Low density lipoprotein (VLDL)

时间窗: baseline & following 8 weeks of daily peanut consumption

assessment of Very Low density lipoprotein (VLDL)

Systolic blood pressure in brachial artery (mmHg)

时间窗: baseline & following 8 weeks of daily peanut consumption

standard blood pressure measures

Neurocognitive Function

时间窗: baseline & following 8 weeks of daily peanut consumption

Performance on the NIH Toolbox Cognitive battery

Arterial stiffness

时间窗: baseline & following 8 weeks of daily peanut consumption

assessment of pulse wave velocity and pulse wave analysis

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Matthew Brothers

Professor

The University of Texas at Arlington

研究点 (2)

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