Cardiovascular DiseasesNCT06318377
Peanuts and Neurocognitive / Cardiovascular Health in Black Individuals
A study testing Peanut group in people with Cardiovascular Diseases and Hypertension, run by The University of Texas at Arlington at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Hypertension, Cognitive Decline
- What is being tested?
- Peanut group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UT Arlington - Science and Engineering Innovation and Research Building
Arlington, Texas, 76019
About this study
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
Read the 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.
- Conditions
- Cardiovascular Diseases, Hypertension, Cognitive Decline, Diet, Healthy
- Being tested
- Peanut group
- Keywords
- endothelial function, brain blood flow, cognition
- Medical subject headings
- Cardiovascular Diseases, Hypertension, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peanut groupDietary supplement
These are commercially available peanuts that are high in antioxidants and are believed to be beneficial for physiological health
| Study group | Role | What they receive |
|---|---|---|
| Peanut Consumption | Experimental | Peanuts are rich in polyphenols and also have anti-inflammatory and antioxidant properties. Receives: Dietary Supplement: Peanut group |
| Non-peanut consumption | No intervention | The non-peanut consumption will simply not be consuming any additional supplements in their diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial Function
Flow medicated dilation of the brachial artery
Measured: baseline & following 8 weeks of daily peanut consumption
Neurocognitive Function
Performance on the NIH Toolbox Cognitive battery
Measured: baseline & following 8 weeks of daily peanut consumption
Systolic blood pressure in brachial artery (mmHg)
standard blood pressure measures
Measured: baseline & following 8 weeks of daily peanut consumption
Plasma concentration of total Cholesterol (Total-C)
assessment of total Cholesterol (Total-C)
Measured: baseline & following 8 weeks of daily peanut consumption
Arterial stiffness
assessment of pulse wave velocity and pulse wave analysis
Measured: baseline & following 8 weeks of daily peanut consumption
Diastolic blood pressure in brachial artery(mmHg)
standard blood pressure measures
Measured: baseline & following 8 weeks of daily peanut consumption
Mean blood pressure in brachial artery (mmHg)
standard blood pressure measures 9(mmHg)
Measured: baseline & following 8 weeks of daily peanut consumption
Plasma concentration of Low density lipoprotein (LDL)
assessment of Low density lipoprotein (LDL)
Measured: baseline & following 8 weeks of daily peanut consumption
Plasma concentration of High density lipoprotein (HDL)
assessment of High density lipoprotein (HDL)
Measured: baseline & following 8 weeks of daily peanut consumption
Plasma concentration of Very Low density lipoprotein (VLDL)
assessment of Very Low density lipoprotein (VLDL)
Measured: baseline & following 8 weeks of daily peanut consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start1 Sep 2022
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Individual will be randomly assigned either an experimental or a control condittion
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas at Arlington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Brothers, The University of Texas at Arlington
- Investigators
- Robert M Brothers, PhD, Principal investigator, University of Texas at Arlington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06318377
- Sponsor's protocol ID
- 2022-0541
- Status last verified
- Mar 2025
- First submitted
- 12 Mar 2024
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peanuts and Neurocognitive / Cardiovascular Health in Black Individuals
- ClinicalTrials.gov ID
- NCT06318377
- Acronym / sponsor ID
- 2022-0541
- Conditions
- Cardiovascular Diseases, Hypertension, Cognitive Decline, Diet, Healthy
- Keywords
- endothelial function, brain blood flow, cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The University of Texas at ArlingtonUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 19 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Individual will be randomly assigned either an experimental or a control condittion
| Arm | Type | Receives |
|---|---|---|
| Peanut Consumption | Experimental | Dietary Supplement: Peanut groupPeanuts are rich in polyphenols and also have anti-inflammatory and antioxidant properties. |
| Non-peanut consumption | No intervention | –The non-peanut consumption will simply not be consuming any additional supplements in their diet |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peanut groupThese are commercially available peanuts that are high in antioxidants and are believed to be beneficial for physiological health | Dietary supplement | Peanut Consumption |
Primary outcome
Endothelial Function
Time frame: baseline & following 8 weeks of daily peanut consumption
Flow medicated dilation of the brachial artery
Neurocognitive Function
Time frame: baseline & following 8 weeks of daily peanut consumption
Performance on the NIH Toolbox Cognitive battery
Systolic blood pressure in brachial artery (mmHg)
Time frame: baseline & following 8 weeks of daily peanut consumption
standard blood pressure measures
Plasma concentration of total Cholesterol (Total-C)
Time frame: baseline & following 8 weeks of daily peanut consumption
assessment of total Cholesterol (Total-C)
Arterial stiffness
Time frame: baseline & following 8 weeks of daily peanut consumption
assessment of pulse wave velocity and pulse wave analysis
Diastolic blood pressure in brachial artery(mmHg)
Time frame: baseline & following 8 weeks of daily peanut consumption
standard blood pressure measures
Mean blood pressure in brachial artery (mmHg)
Time frame: baseline & following 8 weeks of daily peanut consumption
standard blood pressure measures 9(mmHg)
Plasma concentration of Low density lipoprotein (LDL)
Time frame: baseline & following 8 weeks of daily peanut consumption
assessment of Low density lipoprotein (LDL)
Plasma concentration of High density lipoprotein (HDL)
Time frame: baseline & following 8 weeks of daily peanut consumption
assessment of High density lipoprotein (HDL)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Individual participant dataSharing planned: No. There is not plan to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert M Brothers, PhD principal investigator
University of Texas at Arlington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peanut group in people with Cardiovascular Diseases and Hypertension, run by The University of Texas at Arlington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial Function (time frame: baseline & following 8 weeks of daily peanut consumption). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.