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Clinical Trials/NCT05230212
NCT05230212
Completed
Not Applicable

Cognitive Function in Response to a Pecan-Enriched Meal

University of Georgia1 site in 1 country31 target enrollmentFebruary 1, 2021
ConditionsHealthy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
University of Georgia
Enrollment
31
Locations
1
Primary Endpoint
Change in Serial Subtractions, Immediate Word Recall, and Delayed Word Recall.
Status
Completed
Last Updated
3 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2021
End Date
February 25, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jamie Cooper, PhD

Professor

University of Georgia

Eligibility Criteria

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

Outcomes

Primary Outcomes

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 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 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

Secondary Outcomes

  • 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)
  • Change in angiopoietin-like proteins-3 (ANGPTL3), angiopoietin-like-4 (ANGPTL4), and angiopoietin-like-8 (ANGPTL8)(Change from baseline to 4 hours postprandially)
  • Change in subjective measures of appetite(Change from baseline to 4 hours postprandially. Also measured every hour for 10 hours after subject leaves the lab.)
  • Change in total antioxidant capacity(Change from baseline to 4 hours postprandially)
  • Change in oxidized low density lipoprotein (LDL)(Change from baseline to 4 hours postprandially)

Study Sites (1)

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