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临床试验/NCT06318390
NCT06318390已完成不适用

The Impact of KETO5 XOGenius Beverage on Markers of Physiological and Neurocognitive Health

The University of Texas at Arlington2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2023年8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
6
试验地点
2
主要终点
Peripheral systolic blood pressure

研究概览

简要总结

The primary objectives of this application are to 1) investigate the effect of increased daily consumption of the Keto5 XOGenius beverage on outcomes associated with elevated risk for various neurocognitive and pathophysiological conditions/diseases. And 2) to investigate the effect of daily consumption of the Keto5 XOGenius beverage on the following variables: waist circumference, body weight, and body mass index (BMI).

详细描述

Cardiovascular disease (CVD) is the leading cause of morbidity and mortality and affects all individuals. There are many primary risk factors for CVD with some of the primary causes including hypertension, hypercholesteremia, atherosclerosis, and type 2 diabetes mellitus. Furthermore, the rise in the prevalence of various neurocognitive conditions and cerebral vascular diseases including cognitive dysfunction, dementia, stroke, and Alzheimer's disease requires additional attention from a research perspective. While the reasons contributing to CVD and neurocognitive complications/cerebral vascular diseases, is multifactorial, a common link is impaired vascular function.

A hallmark of impaired vascular function is elevated arterial stiffness and a decrease in the vasodilator capacity in the brain and periphery. Reduced vascular function, due to elevated oxidative stress and systemic inflammation is implicated as a primary contributing factor for these attenuated vasodilatory responses. Therefore, it is reasonable to speculate that an approach targeting these pathways could abolish or minimize this elevated risk. One such approach could be increased dietary consumption of a naturally based product that is high in the ketone β-hydroxybutyrate (β-OHB). Importantly, recent research has indicated that short-term dietary supplementation (i.e. up to 14 days) of β-OHB has many important physiological benefits including improvements in peripheral and cerebral vascular function as well as cognitive function. Furthermore, it has been demonstrated that these beneficial effects are due in part to reductions in systemic oxidative stress and inflammation. Furthermore, this approach of oral supplementation has been demonstrated to be safe and well tolerated in various populations. In this regard, the overall research objective of this proposal is to determine the acute and chronic impact of daily supplementation of a Keto5 XOGenius on indices of physiological and neurocognitive health. Specifically, the Keto5 XOGenius is the product that we are interested in investigating in this proposal

The following objectives/aims will be explored:

  1. Primary Aim - The primary endpoint is the effect of increased daily consumption of the Keto5 XOGenius beverage 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, 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 consumption of the Keto5 XOGenius beverage on the following variables: waist circumference, body weight, and body mass index (BMI).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

  • Men and women who are 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.
  • Food allergies
  • Type I diabetes/Type II diabetes, and/or a history of hypoglycemia.
  • History of irritable bowel syndrome or inflammatory bowel disease.
  • Currently taking any medications that are designed to treat a cardiovascular or metabolic condition
  • Pregnant women
  • Breast feeding women
  • Allergy to spandex/lycra/latex
  • Use of prescription stimulants

结局指标

主要结局

Peripheral systolic blood pressure

时间窗: baseline, 2 weeks post daily consumption of Keto5 XOgenius, & 4 weeks of daily keto5 XOgenius consumption

standard blood pressure measures (mmHg)

Plasma concentration of Total Cholesterol (Total-C)

时间窗: baseline, 2 weeks post daily consumption of Keto5 XOgenius, & 4 weeks of daily keto5 XOgenius consumption

assessment of Total Cholesterol

Plasma concentration of Low Density Lipoprotein (LDL-C)

时间窗: baseline, 2 weeks post daily consumption of Keto5 XOgenius, & 4 weeks of daily keto5 XOgenius consumption

assessment of Low Density Lipoprotein (LDL-C)

Peripheral mean blood pressure (mean)

时间窗: baseline, 2 weeks post daily consumption of Keto5 XOgenius, & 4 weeks of daily keto5 XOgenius consumption

standard blood pressure measures (mmHg)

Endothelial Function

时间窗: baseline, 2 weeks post daily consumption of Keto5 XOgenius, & 4 weeks of daily keto5 XOgenius consumption

Flow medicated dilation of the brachial artery (% change)

Neurocognitive Function

时间窗: baseline, 2 weeks post daily consumption of Keto5 XOgenius, & 4 weeks of daily keto5 XOgenius consumption

Performance on the NIH Toolbox Cognitive battery

Arterial stiffness

时间窗: baseline, 2 weeks post daily consumption of Keto5 XOgenius, & 4 weeks of daily keto5 XOgenius consumption

assessment of pulse wave velocity and pulse wave analysis

Peripheral diastolic blood pressure (diastolic)

时间窗: baseline, 2 weeks post daily consumption of Keto5 XOgenius, & 4 weeks of daily keto5 XOgenius consumption

standard blood pressure measures (mmHg)

Plasma concentration of High Density Lipoprotein (HDL-C)

时间窗: baseline, 2 weeks post daily consumption of Keto5 XOgenius, & 4 weeks of daily keto5 XOgenius consumption

assessment of High Density Lipoprotein (HDL-C)

Plasma concentration of Very Low Density Lipoprotein (VLDL-C)

时间窗: baseline, 2 weeks post daily consumption of Keto5 XOgenius, & 4 weeks of daily keto5 XOgenius consumption

assessment of Low Density Lipoprotein (VLDL-C)

Plasma concentration of Triglycerides (TG)

时间窗: baseline, 2 weeks post daily consumption of Keto5 XOgenius, & 4 weeks of daily keto5 XOgenius consumption

assessment of Triglycerides (TG)

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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