NCT05230212

Brief Summary

Human cognitive function is affected by age-related changes, with some areas beginning to decline in mid-adulthood and worsening with age. However, there is evidence that dietary interventions or the incorporation of certain healthy foods or nutrients, into the diet can have protective effects against cognitive decline. These foods include nutrients such as polyunsaturated fats, vitamins E and C, and polyphenols. Pecans are a rich source of polyunsaturated fatty acids, antioxidants (including polyphenols), and vitamin E. Pecans contain more total phenols than any other tree nut suggesting that they may be an ideal bioactive food to enhance cognitive performance; however, the relationship between pecan consumption and cognitive functioning has never been assessed. The overall goal behind this research is to determine the relationship between antioxidant-rich pecans and cognitive functioning in a postprandial state.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Feb 2021

Longer than P75 for not_applicable healthy

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

February 1, 2021

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 8, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2023

Completed
Last Updated

April 14, 2023

Status Verified

April 1, 2023

Enrollment Period

2.1 years

First QC Date

January 22, 2022

Last Update Submit

April 12, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Change in Alphabetic Working Memory, Choice Reaction Time, Digit Vigilance, N-back test, Word Recognition, Rapid Visual Information Processing, Picture Recognition, Immediate Word Recall, and Delayed Word Recall

    Measured by Computerized Mental Performance Assessment System (COMPASS) computed scores of percent accuracy (total overall target stimuli/novel stimuli) Brain, Performance, and Nutrition Research Centre, Northumbria University

    Change from baseline to 4 hours postprandially

  • Change in Serial Subtractions, Immediate Word Recall, and Delayed Word Recall.

    Measured by Computerized Mental Performance Assessment System (COMPASS) computed scores of the number of responses (total correct responses/error responses) Brain, Performance, and Nutrition Research Centre, Northumbria University

    Change from baseline to 4 hours postprandially

  • Change in Alphabetic Working Memory, Choice Reaction Time, Digit Vigilance, N-back, Picture Recognition, Rapid Visual Information Processing, Word Recognition.

    Measured by Computerized Mental Performance Assessment System (COMPASS) computed scores of reaction time (msec) (overall, correct response, target stimuli, novel stimuli, number of false alarms, and number of missed sequences) Brain, Performance, and Nutrition Research Centre, Northumbria University

    Change from baseline to 4 hours postprandially

Secondary Outcomes (9)

  • Change in glucose and triglycerides

    Change from baseline to 4 hours postprandially

  • Change in physiologic measures of appetite

    Change from baseline to 4 hours postprandially

  • Change in lipid peroxidation

    Change from baseline to 4 hours postprandially

  • Change in insulin

    Change from baseline to 4 hours postprandially

  • Change in non-esterified free fatty acids (NEFA)

    Change from baseline to 4 hours postprandially

  • +4 more secondary outcomes

Other Outcomes (3)

  • Change in subjective measures of motivation

    Change from baseline to 4 hours postprandially

  • Change in subjective measures of alertness, stress, and tranquility

    Change from baseline to 4 hours postprandially

  • Change in subjective degree of sleepiness

    Change from baseline to 4 hours postprandially

Study Arms (2)

Pecan Breakfast Shake

EXPERIMENTAL

Participants will be given a breakfast shake consisting primarily of pecans, and 1% milk.

Other: Pecan Breakfast Shake

Cream Breakfast Shake

ACTIVE COMPARATOR

Participants will be given a breakfast shake consisting primarily of heavy whipping cream.

Other: Cream Breakfast Shake

Interventions

The pecan breakfast shake contains 68 grams of blended raw pecans. Participants will consume this shake at either visit 1 or visit 2 depending on randomization procedures.

Pecan Breakfast Shake

The cream breakfast shake contains 138 grams of heavy whipping cream. Participants will consume this shake at either visit 1 or visit 2 depending on randomization procedures.

Cream Breakfast Shake

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • to 30-years-old
  • Healthy individuals
  • Men and Women
  • Normal body mass index (BMI) (18.5-24.9kg/m2). If BMI is 25 or greater, subjects can still qualify if their body fat percentage falls within healthy ranges defined as Men: 5-20%, and Women: 15-30% \[22\]
  • Individuals with normal or corrected to normal vision
  • Low-risk alcohol use as assessed by the AUDIT questionnaire (need a score of 7 or lower)
  • No or minimal depression symptoms as indicated by the Beck's Depression Inventory (need a score of 9 or lower)
  • Cognitive competence for education level and age as measured by the Mini-Mental State Examination (need a score of 26 or higher)

You may not qualify if:

  • All chronic diseases (including, but not limited to, renal or bowel diseases, cardiovascular disease, and any form of diabetes)
  • Known neurological, cognitive, or psychiatric conditions (including, but not limited to, mood disorders, anxiety disorders, and depression)
  • Prescription medication use (with the exception of female contraception methods)
  • Dietary supplement use (including, but not limited to, multivitamins and fish oil supplements)
  • Alcohol intake \>3 drinks/d for males or \>2 drinks/d for females
  • Diagnosis of ADHD or a learning difficulty (including, but not limited to, dyslexia)
  • History of head injury (defined as loss of consciousness more than 10 minutes)
  • History of inflammatory disorders (including, but not limited to, migraines, stroke, hypertension, hypercoagulation, vascular disease, thyroid conditions, blood disorders, coagulation disorders)
  • Food allergies/sensitivities to foods provided in this protocol including tree nuts, gluten, and or lactose/dairy
  • Regular consumption of nuts and/or nut butters defined as consumption of \>2 servings (60g) of tree nuts or nut butters (e.g., peanut butter, almond butter) per week
  • High caffeine consumption, defined as \>400mg/d
  • Individuals adhering to special diets (including, but not limited to, the ketogenic diet, intermittent fasting, Atkins diet, vegan diet, vegetarian diet, or carbohydrate-restricted diets)
  • Illicit drug use
  • Smoking or use of tobacco products
  • Color-blindness
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Georgia- Department of Foods and Nutrition

Athens, Georgia, 30605, United States

Location

Related Publications (2)

  • Guadagni AJ, Prater MC, Paton CM, Cooper JA. Cognitive function in response to a pecan-enriched meal: a randomized, double-blind, cross-over study in healthy adults. Nutr Neurosci. 2025 Sep;28(9):1075-1092. doi: 10.1080/1028415X.2025.2461018. Epub 2025 Feb 13.

  • Prater MC, Guadagni AJ, Cooper JA. Postprandial appetite responses to a pecan enriched meal: A randomized crossover trial. Appetite. 2024 Oct 1;201:107598. doi: 10.1016/j.appet.2024.107598. Epub 2024 Jul 4.

Study Officials

  • Jamie A Cooper, PhD

    University of Georgia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Involved researchers and participants are blinded to which breakfast shake they are administering and/or receiving.
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: This trial will be a double-blinded, randomized, cross-over design. There will be 2 testing visits in which each participant will be randomized to receive either the control (cream) shake or the pecan shake at visit 1; they will receive the opposing shake at visit 2. There will be a 6-8 day washout period between visit 1 and visit 2.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 22, 2022

First Posted

February 8, 2022

Study Start

February 1, 2021

Primary Completion

February 25, 2023

Study Completion

February 25, 2023

Last Updated

April 14, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

The plan is to share group averages through publication.

Locations