NCT06318377

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 19, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

April 1, 2025

Status Verified

March 1, 2025

Enrollment Period

1.9 years

First QC Date

March 12, 2024

Last Update Submit

March 26, 2025

Conditions

Keywords

endothelial functionbrain blood flowcognition

Outcome Measures

Primary Outcomes (10)

  • Endothelial Function

    Flow medicated dilation of the brachial artery

    baseline & following 8 weeks of daily peanut consumption

  • Neurocognitive Function

    Performance on the NIH Toolbox Cognitive battery

    baseline & following 8 weeks of daily peanut consumption

  • Systolic blood pressure in brachial artery (mmHg)

    standard blood pressure measures

    baseline & following 8 weeks of daily peanut consumption

  • Plasma concentration of total Cholesterol (Total-C)

    assessment of total Cholesterol (Total-C)

    baseline & following 8 weeks of daily peanut consumption

  • Arterial stiffness

    assessment of pulse wave velocity and pulse wave analysis

    baseline & following 8 weeks of daily peanut consumption

  • Diastolic blood pressure in brachial artery(mmHg)

    standard blood pressure measures

    baseline & following 8 weeks of daily peanut consumption

  • Mean blood pressure in brachial artery (mmHg)

    standard blood pressure measures 9(mmHg)

    baseline & following 8 weeks of daily peanut consumption

  • Plasma concentration of Low density lipoprotein (LDL)

    assessment of Low density lipoprotein (LDL)

    baseline & following 8 weeks of daily peanut consumption

  • Plasma concentration of High density lipoprotein (HDL)

    assessment of High density lipoprotein (HDL)

    baseline & following 8 weeks of daily peanut consumption

  • Plasma concentration of Very Low density lipoprotein (VLDL)

    assessment of Very Low density lipoprotein (VLDL)

    baseline & following 8 weeks of daily peanut consumption

Study Arms (2)

Peanut Consumption

EXPERIMENTAL

Peanuts are rich in polyphenols and also have anti-inflammatory and antioxidant properties.

Dietary Supplement: Peanut group

Non-peanut consumption

NO INTERVENTION

The non-peanut consumption will simply not be consuming any additional supplements in their diet

Interventions

Peanut groupDIETARY_SUPPLEMENT

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

Peanut Consumption

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Individuals with peanut allergy
  • Individuals in hypertensive crisis
  • Pregnant women
  • Breast feeding
  • Allergies to spandex/lycra

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT Arlington - Science and Engineering Innovation and Research Building

Arlington, Texas, 76019, United States

Location

MeSH Terms

Conditions

Cardiovascular DiseasesHypertensionCognitive Dysfunction

Condition Hierarchy (Ancestors)

Vascular DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Robert M Brothers, PhD

    University of Texas at Arlington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Individual will be randomly assigned either an experimental or a control condittion
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 12, 2024

First Posted

March 19, 2024

Study Start

September 1, 2022

Primary Completion

July 31, 2024

Study Completion

July 31, 2024

Last Updated

April 1, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

There is not plan to share IPD

Locations