Peanuts and Neurocognitive / Cardiovascular Health in Black Individuals

Healthy Clinical Trial

Official title:

Peanuts and Neurocognitive / Cardiovascular Health in Black Individuals

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06318377
• Other study ID #: 2022-0541
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: August 31, 2025

Study information

• Verified date: June 2024
• Source: The University of Texas at Arlington
• Contact: Robert M Brothers, PhD
• Phone: 8172723156
• Email: matthew.brothers[@]uta.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cognitive Decline
• Cognitive Dysfunction
• Diet
• Healthy
• Hypertension

Intervention

Dietary Supplement:
• Peanut group
These are commercially available peanuts that are high in antioxidants and are believed to be beneficial for physiological health

Locations

Country	Name	City	State
United States	UT Arlington - Science and Engineering Innovation and Research Building	Arlington	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas at Arlington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial Function	Flow medicated dilation of the brachial artery	baseline & following 8 weeks of daily peanut consumption
Primary	Neurocognitive Function	Performance on the NIH Toolbox Cognitive battery	baseline & following 8 weeks of daily peanut consumption
Primary	Systolic blood pressure in brachial artery (mmHg)	standard blood pressure measures	baseline & following 8 weeks of daily peanut consumption
Primary	Plasma concentration of total Cholesterol (Total-C)	assessment of total Cholesterol (Total-C)	baseline & following 8 weeks of daily peanut consumption
Primary	Arterial stiffness	assessment of pulse wave velocity and pulse wave analysis	baseline & following 8 weeks of daily peanut consumption
Primary	Diastolic blood pressure in brachial artery(mmHg)	standard blood pressure measures	baseline & following 8 weeks of daily peanut consumption
Primary	Mean blood pressure in brachial artery (mmHg)	standard blood pressure measures 9(mmHg)	baseline & following 8 weeks of daily peanut consumption
Primary	Plasma concentration of Low density lipoprotein (LDL)	assessment of Low density lipoprotein (LDL)	baseline & following 8 weeks of daily peanut consumption
Primary	Plasma concentration of High density lipoprotein (HDL)	assessment of High density lipoprotein (HDL)	baseline & following 8 weeks of daily peanut consumption
Primary	Plasma concentration of Very Low density lipoprotein (VLDL)	assessment of Very Low density lipoprotein (VLDL)	baseline & following 8 weeks of daily peanut consumption