Pecan Consumption and Cognitive Function

April 12, 2023 updated by: Jamie Cooper, PhD, University of Georgia

Cognitive Function in Response to a Pecan-Enriched Meal

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.

Study Overview

Status

Completed

Conditions

Detailed Description

This trial will be a double-blinded, randomized, cross-over design in humans. There will be two study visits for two different test meals administered in random order. The two testing visits (v1 and v2) include blood draws and repetitions of the cognitive battery after consuming one of the two different test meals containing 1% milk, Nesquik, and either: 1) pecans, or 2) heavy whipping cream. There will be a 6-8 day washout period between each study visit.

Hypothesis: Investigators hypothesize that the pecan-enriched meal will 1.) improve performance on select measures of postprandial cognitive functioning (such as executive functioning, memory, learning, attention, and processing speed) 2.) improve postprandial markers of glycemic control, inflammation, antioxidant capacity, coagulation potential, and 3.) present a similar suppression of subjective appetite compared to the isocaloric, control meal that does not contain pecans.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Georgia
      • Athens, Georgia, United States, 30605
        • University of Georgia- Department of Foods and Nutrition

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 18 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)

Exclusion Criteria:

  • 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
  • History of current renal or bowel disease
  • Females who are currently pregnant or lactating
  • Active individuals (defined as performing >5 hours/week of scheduled exercise)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pecan Breakfast Shake
Participants will be given a breakfast shake consisting primarily of pecans, and 1% milk.
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.
Active Comparator: Cream Breakfast Shake
Participants will be given a breakfast shake consisting primarily of heavy whipping cream.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: Change from baseline to 4 hours postprandially

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.
Time Frame: Change from baseline to 4 hours postprandially

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.
Time Frame: Change from baseline to 4 hours postprandially

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in glucose and triglycerides
Time Frame: Change from baseline to 4 hours postprandially
Blood samples will be collected to measure Glucose (mg/dL), Triglycerides (mg/dL)
Change from baseline to 4 hours postprandially
Change in physiologic measures of appetite
Time Frame: Change from baseline to 4 hours postprandially
Blood samples will be collected to measure Peptide YY (PYY) (pg/mL), Cholecystokinin (CCK) (pg/mL), Ghrelin (pg/mL), Glucagon-like Peptide 1 (GLP-1) (pg/mL), Gastric Inhibitory Peptide (GIP) (pg/mL), pancreatic peptide (PP) (pg/mL).
Change from baseline to 4 hours postprandially
Change in lipid peroxidation
Time Frame: Change from baseline to 4 hours postprandially
Malondialdehyde (MDA) (uM) measured via Thiobarbituric acid reactive substances (TBARS) assay.
Change from baseline to 4 hours postprandially
Change in insulin
Time Frame: Change from baseline to 4 hours postprandially
Insulin (uU/mL)
Change from baseline to 4 hours postprandially
Change in non-esterified free fatty acids (NEFA)
Time Frame: Change from baseline to 4 hours postprandially
NEFA (mEq/L)
Change from baseline to 4 hours postprandially
Change in angiopoietin-like proteins-3 (ANGPTL3), angiopoietin-like-4 (ANGPTL4), and angiopoietin-like-8 (ANGPTL8)
Time Frame: Change from baseline to 4 hours postprandially
ANGPTL-3 (pg/mL), ANGPTL-4 (pg/mL), ANGPTL-8 (pg/mL)
Change from baseline to 4 hours postprandially
Change in subjective measures of appetite
Time Frame: Change from baseline to 4 hours postprandially. Also measured every hour for 10 hours after subject leaves the lab.
Appetite Visual Analog Scale (VAS) (mm). The range of scores on the continuous VAS is 0-100 mm. Zero represents no hunger, fullness, prospective consumption, and desire to eat, while 100 represents the greatest feeling of these outcomes.
Change from baseline to 4 hours postprandially. Also measured every hour for 10 hours after subject leaves the lab.
Change in total antioxidant capacity
Time Frame: Change from baseline to 4 hours postprandially
Total antioxidant capacity (uM trolox equivalents) measured via Oxygen Radical Absorbance Capacity (ORAC) assay.
Change from baseline to 4 hours postprandially
Change in oxidized low density lipoprotein (LDL)
Time Frame: Change from baseline to 4 hours postprandially
Oxidized Low-Density Lipoprotein (ox-LDL) (mg/dL)
Change from baseline to 4 hours postprandially

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in subjective measures of motivation
Time Frame: Change from baseline to 4 hours postprandially
Motivation Visual Analog Scale (VAS) (mm). The range of scores on the continuous VAS is 0-100 mm. Zero represents no motivation while 100 represents the greatest feeling of this outcome.
Change from baseline to 4 hours postprandially
Change in subjective measures of alertness, stress, and tranquility
Time Frame: Change from baseline to 4 hours postprandially

Computerized Mental Performance Assessment System (COMPASS) - Brain, Performance, and Nutrition Research Centre, Northumbria University.

Visual Analogue Mood Scales (VAMS) (mm). The range of scores on the continuous VAS is 0-100 mm. Zero represents lesser feeling of alertness, stress, and tranquility, while 100 represents the greatest feeling of these outcomes.

Change from baseline to 4 hours postprandially
Change in subjective degree of sleepiness
Time Frame: Change from baseline to 4 hours postprandially
Stanford Sleepiness Scale, in which the scale is rated from 1 to 7. A rating of 1 indicates feelings of being wide awake/alert/vital/active and a rating of 7 indicates the greatest feelings of sleepiness.
Change from baseline to 4 hours postprandially

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jamie A Cooper, PhD, University of Georgia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Actual)

February 25, 2023

Study Completion (Actual)

February 25, 2023

Study Registration Dates

First Submitted

January 22, 2022

First Submitted That Met QC Criteria

February 7, 2022

First Posted (Actual)

February 8, 2022

Study Record Updates

Last Update Posted (Actual)

April 14, 2023

Last Update Submitted That Met QC Criteria

April 12, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • PROJECT00004889

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The plan is to share group averages through publication.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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