Clinical trial NCT05230212: Pecan Consumption and Cognitive Function
Official title: Cognitive Function in Response to a Pecan-Enriched Meal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of Georgia
Sponsor class: OTHER
First posted: 2022-02-08
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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
* 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)

Primary outcomes:
measure: 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
timeFrame: Change from baseline to 4 hours postprandially
measure: Change in Serial Subtractions, Immediate Word Recall, and Delayed Word Recall.
timeFrame: Change from baseline to 4 hours postprandially
measure: Change in Alphabetic Working Memory, Choice Reaction Time, Digit Vigilance, N-back, Picture Recognition, Rapid Visual Information Processing, Word Recognition.
timeFrame: Change from baseline to 4 hours postprandially
Secondary outcomes:
measure: Change in glucose and triglycerides
timeFrame: Change from baseline to 4 hours postprandially
measure: Change in physiologic measures of appetite
timeFrame: Change from baseline to 4 hours postprandially
measure: Change in lipid peroxidation
timeFrame: Change from baseline to 4 hours postprandially
measure: Change in insulin
timeFrame: Change from baseline to 4 hours postprandially
measure: Change in non-esterified free fatty acids (NEFA)
timeFrame: Change from baseline to 4 hours postprandially
measure: Change in angiopoietin-like proteins-3 (ANGPTL3), angiopoietin-like-4 (ANGPTL4), and angiopoietin-like-8 (ANGPTL8)
timeFrame: Change from baseline to 4 hours postprandially
measure: Change in subjective measures of appetite
timeFrame: Change from baseline to 4 hours postprandially. Also measured every hour for 10 hours after subject leaves the lab.
measure: Change in total antioxidant capacity
timeFrame: Change from baseline to 4 hours postprandially
measure: Change in oxidized low density lipoprotein (LDL)
timeFrame: Change from baseline to 4 hours postprandially
Other outcomes:
measure: Change in subjective measures of motivation
timeFrame: Change from baseline to 4 hours postprandially
measure: Change in subjective measures of alertness, stress, and tranquility
timeFrame: Change from baseline to 4 hours postprandially
measure: Change in subjective degree of sleepiness
timeFrame: Change from baseline to 4 hours postprandially
Locations:
city: Athens
country: United States
facility: University of Georgia- Department of Foods and Nutrition
state: Georgia
Study officials:
affiliation: University of Georgia
name: Jamie A Cooper, PhD
role: PRINCIPAL_INVESTIGATOR
References: