HealthyNCT05230212
Pecan Consumption and Cognitive Function
A study testing Pecan Breakfast Shake and Cream Breakfast Shake in people with Healthy, run by University of Georgia at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Pecan Breakfast Shake and Cream Breakfast Shake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 25 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 18Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Georgia- Department of Foods and Nutrition
Athens, Georgia, 30605
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Pecan Breakfast Shake, Cream Breakfast Shake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pecan Breakfast ShakeOther
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.
Cream Breakfast ShakeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Pecan Breakfast Shake | Experimental | Participants will be given a breakfast shake consisting primarily of pecans, and 1% milk. Receives: Other: Pecan Breakfast Shake |
| Cream Breakfast Shake | Active comparator | Participants will be given a breakfast shake consisting primarily of heavy whipping cream. Receives: Other: Cream Breakfast Shake |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Change from baseline to 4 hours postprandially
Secondary outcomes (9)
Change in glucose and triglycerides
Blood samples will be collected to measure Glucose (mg/dL), Triglycerides (mg/dL)
Measured: Change from baseline to 4 hours postprandially
Change in physiologic measures of appetite
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).
Measured: Change from baseline to 4 hours postprandially
Change in lipid peroxidation
Malondialdehyde (MDA) (uM) measured via Thiobarbituric acid reactive substances (TBARS) assay.
Measured: Change from baseline to 4 hours postprandially
Change in insulin
Insulin (uU/mL)
Measured: Change from baseline to 4 hours postprandially
Change in non-esterified free fatty acids (NEFA)
NEFA (mEq/L)
Measured: Change from baseline to 4 hours postprandially
Change in angiopoietin-like proteins-3 (ANGPTL3), angiopoietin-like-4 (ANGPTL4), and angiopoietin-like-8 (ANGPTL8)
ANGPTL-3 (pg/mL), ANGPTL-4 (pg/mL), ANGPTL-8 (pg/mL)
Measured: Change from baseline to 4 hours postprandially
Change in subjective measures of appetite
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.
Measured: Change from baseline to 4 hours postprandially. Also measured every hour for 10 hours after subject leaves the lab.
Change in total antioxidant capacity
Total antioxidant capacity (uM trolox equivalents) measured via Oxygen Radical Absorbance Capacity (ORAC) assay.
Measured: Change from baseline to 4 hours postprandially
Change in oxidized low density lipoprotein (LDL)
Oxidized Low-Density Lipoprotein (ox-LDL) (mg/dL)
Measured: Change from baseline to 4 hours postprandially
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start1 Feb 2021
- Primary completion25 Feb 2023
- Study completion25 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Georgia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamie Cooper, PhD, University of Georgia
- Investigators
- Jamie A Cooper, PhD, Principal investigator, University of Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05230212
- Sponsor's protocol ID
- PROJECT00004889
- Status last verified
- Apr 2023
- First submitted
- 22 Jan 2022
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The plan is to share group averages through publication.
Publications
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.
PubMed 39945748Prater 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.
PubMed 38971424
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Function in Response to a Pecan-Enriched Meal
- ClinicalTrials.gov ID
- NCT05230212
- Acronym / sponsor ID
- PROJECT00004889
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of GeorgiaUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 25 Feb 2023 (actual)
- Study completion
- 25 Feb 2023 (actual)
- First posted
- 8 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Pecan Breakfast Shake | Experimental | Other: Pecan Breakfast ShakeParticipants will be given a breakfast shake consisting primarily of pecans, and 1% milk. |
| Cream Breakfast Shake | Active comparator | Other: Cream Breakfast ShakeParticipants will be given a breakfast shake consisting primarily of heavy whipping cream. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pecan Breakfast ShakeThe 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. | Other | Pecan Breakfast Shake |
| Cream Breakfast ShakeThe 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. | Other | Cream Breakfast Shake |
Primary outcome
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 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, 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
9 secondary outcomes
Change in glucose and triglycerides
Time frame: Change from baseline to 4 hours postprandially
Change in physiologic measures of appetite
Time frame: Change from baseline to 4 hours postprandially
Change in lipid peroxidation
Time frame: Change from baseline to 4 hours postprandially
Change in insulin
Time frame: Change from baseline to 4 hours postprandially
Change in non-esterified free fatty acids (NEFA)
Time frame: 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
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.
Change in total antioxidant capacity
Time frame: Change from baseline to 4 hours postprandially
Change in oxidized low density lipoprotein (LDL)
Time frame: Change from baseline to 4 hours postprandially
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- Derived from this study: PubMed 39945748Guadagni 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.
- Derived from this study: PubMed 38971424Prater 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.
- Individual participant dataSharing planned: No. The plan is to share group averages through publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamie A Cooper, PhD principal investigator
University of Georgia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pecan Breakfast Shake and Cream Breakfast Shake in people with Healthy, run by University of Georgia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Change from baseline to 4 hours postprandially). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05230212, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2023.