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Completed

NCT Number: NCT06318377

Peanuts and Neurocognitive / Cardiovascular Health in Black Individuals

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

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Key information

Conditions

Cardiovascular Diseases Cognition Disorders Cognitive Decline Cognitive Dysfunction Diet Healthy Hypertension Mental Disorders Neurocognitive Disorders Vascular Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UT Arlington - Science and Engineering Innovation and Research Building

Arlington, Texas, 76019, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peanut group

Dietary Supplement

These are commercially available peanuts that are high in antioxidants and are believed to be beneficial for physiological health

Primary outcomes

  1. Endothelial Function

    Time frame: baseline & following 8 weeks of daily peanut consumption

    Flow medicated dilation of the brachial artery

  2. Neurocognitive Function

    Time frame: baseline & following 8 weeks of daily peanut consumption

    Performance on the NIH Toolbox Cognitive battery

  3. Systolic blood pressure in brachial artery (mmHg)

    Time frame: baseline & following 8 weeks of daily peanut consumption

    standard blood pressure measures

  4. Plasma concentration of total Cholesterol (Total-C)

    Time frame: baseline & following 8 weeks of daily peanut consumption

    assessment of total Cholesterol (Total-C)

  5. Arterial stiffness

    Time frame: baseline & following 8 weeks of daily peanut consumption

    assessment of pulse wave velocity and pulse wave analysis

  6. Diastolic blood pressure in brachial artery(mmHg)

    Time frame: baseline & following 8 weeks of daily peanut consumption

    standard blood pressure measures

  7. Mean blood pressure in brachial artery (mmHg)

    Time frame: baseline & following 8 weeks of daily peanut consumption

    standard blood pressure measures 9(mmHg)

  8. Plasma concentration of Low density lipoprotein (LDL)

    Time frame: baseline & following 8 weeks of daily peanut consumption

    assessment of Low density lipoprotein (LDL)

  9. Plasma concentration of High density lipoprotein (HDL)

    Time frame: baseline & following 8 weeks of daily peanut consumption

    assessment of High density lipoprotein (HDL)

  10. 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)

Sponsors and collaborators

Lead sponsor

The University of Texas at Arlington

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 19, 2024
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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