Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06318377
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-03-12
Brief Title:
Peanuts and Neurocognitive Cardiovascular Health in Black Individuals
Sponsor:
The University of Texas at Arlington
Organization:
The University of Texas at Arlington
Study Overview
Official Title:
Peanuts and Neurocognitive Cardiovascular Health in Black Individuals
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 Alzheimers disease While the association between the BL population neurocognitive complicationscerebral 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 andor heightened sympathetic vascular transduction ie 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 conditionsdiseases These outcomes include cognitive function central and peripheral arterial blood pressure cerebral and peripheral blood vessel functionhealth autonomic function - ie vasoconstrictor responsiveness to efferent sympathetic neural outflow sympathetic vascular transduction and blood biomarkers eg indices of inflammation oxidative stress insulin resistancediabetes 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
A hallmark of impaired vascular function is elevated arterial stiffness a decrease in the vasodilator capacity andor heightened sympathetic vascular transduction ie 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 conditionsdiseases These outcomes include cognitive function central and peripheral arterial blood pressure cerebral and peripheral blood vessel functionhealth autonomic function - ie vasoconstrictor responsiveness to efferent sympathetic neural outflow sympathetic vascular transduction and blood biomarkers eg indices of inflammation oxidative stress insulin resistancediabetes 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None