- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06318377
Peanuts and Neurocognitive / Cardiovascular Health in Black Individuals
Study Overview
Status
Intervention / Treatment
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 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:
- 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).
- 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).
- 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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Arlington, Texas, United States, 76019
- UT Arlington - Science and Engineering Innovation and Research Building
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Peanut Consumption
Peanuts are rich in polyphenols and also have anti-inflammatory and antioxidant properties.
|
These are commercially available peanuts that are high in antioxidants and are believed to be beneficial for physiological health
|
|
No Intervention: Non-peanut consumption
The non-peanut consumption will simply not be consuming any additional supplements in their diet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Endothelial Function
Time Frame: baseline & following 8 weeks of daily peanut consumption
|
Flow medicated dilation of the brachial artery
|
baseline & following 8 weeks of daily peanut consumption
|
|
Neurocognitive Function
Time Frame: baseline & following 8 weeks of daily peanut consumption
|
Performance on the NIH Toolbox Cognitive battery
|
baseline & following 8 weeks of daily peanut consumption
|
|
Arterial stiffness
Time Frame: baseline & following 8 weeks of daily peanut consumption
|
assessment of pulse wave velocity and pulse wave analysis
|
baseline & following 8 weeks of daily peanut consumption
|
|
Systolic blood pressure in brachial artery (mmHg)
Time Frame: baseline & following 8 weeks of daily peanut consumption
|
standard blood pressure measures
|
baseline & following 8 weeks of daily peanut consumption
|
|
Plasma concentration of total Cholesterol (Total-C)
Time Frame: baseline & following 8 weeks of daily peanut consumption
|
assessment of total Cholesterol (Total-C)
|
baseline & following 8 weeks of daily peanut consumption
|
|
Diastolic blood pressure in brachial artery(mmHg)
Time Frame: baseline & following 8 weeks of daily peanut consumption
|
standard blood pressure measures
|
baseline & following 8 weeks of daily peanut consumption
|
|
Mean blood pressure in brachial artery (mmHg)
Time Frame: baseline & following 8 weeks of daily peanut consumption
|
standard blood pressure measures 9(mmHg)
|
baseline & following 8 weeks of daily peanut consumption
|
|
Plasma concentration of Low density lipoprotein (LDL)
Time Frame: baseline & following 8 weeks of daily peanut consumption
|
assessment of Low density lipoprotein (LDL)
|
baseline & following 8 weeks of daily peanut consumption
|
|
Plasma concentration of High density lipoprotein (HDL)
Time Frame: baseline & following 8 weeks of daily peanut consumption
|
assessment of High density lipoprotein (HDL)
|
baseline & following 8 weeks of daily peanut consumption
|
|
Plasma concentration of Very Low density lipoprotein (VLDL)
Time Frame: baseline & following 8 weeks of daily peanut consumption
|
assessment of Very Low density lipoprotein (VLDL)
|
baseline & following 8 weeks of daily peanut consumption
|
Collaborators and Investigators
Investigators
- Principal Investigator: Robert M Brothers, PhD, University of Texas at Arlington
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-0541
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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