- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05230212
Pecan Consumption and Cognitive Function
Cognitive Function in Response to a Pecan-Enriched Meal
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Georgia
-
Athens, Georgia, United States, 30605
- University of Georgia- Department of Foods and Nutrition
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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
Sponsor
Investigators
- Principal Investigator: Jamie A Cooper, PhD, University of Georgia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on Pecan Breakfast Shake
-
University of GeorgiaGeorgia Commodity Commission for Pecans; American Pecan CounselRecruitingChange in Plasma Urolithins and Vitamin E After Pecan ConsumptionUnited States
-
University of GeorgiaGeorgia Pecan CommissionCompleted
-
The University of The West IndiesNot yet recruitingOverweight or Obesity | Diabetes Mellitus, Type II
-
University of GeorgiaAmerican Pecan CouncilCompleted
-
University of GeorgiaRecruitingDyslipidemias | Overweight and Obesity | Nutrition, HealthyUnited States
-
Radboud University Medical CenterCompletedCardiovascular DiseasesNetherlands
-
Beth Israel Deaconess Medical CenterCompleted
-
University of PittsburghCompletedEmesisUnited States
-
Wageningen UniversityDutch Diabetes Research FoundationCompletedObesity | Cardiovascular Disease | Diabetes Type 2Netherlands