Pecan Consumption and Cognitive Function

NCT ID: NCT05230212

Last Updated: 2023-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2023-02-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators
Involved researchers and participants are blinded to which breakfast shake they are administering and/or receiving.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pecan Breakfast Shake

Participants will be given a breakfast shake consisting primarily of pecans, and 1% milk.

Group Type EXPERIMENTAL

Pecan Breakfast Shake

Intervention Type OTHER

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 Shake

Participants will be given a breakfast shake consisting primarily of heavy whipping cream.

Group Type ACTIVE_COMPARATOR

Cream Breakfast Shake

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pecan Breakfast Shake

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.

Intervention Type OTHER

Cream Breakfast Shake

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Georgia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jamie Cooper, PhD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jamie A Cooper, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Georgia

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Georgia- Department of Foods and Nutrition

Athens, Georgia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 39945748 (View on PubMed)

Prater 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.

Reference Type DERIVED
PMID: 38971424 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PROJECT00004889

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Mediterranean Diet and Mushrooms
NCT04259229 COMPLETED NA
Eating Peanuts for Health
NCT01886326 COMPLETED NA
Effects of Meal Macronutrients on Postprandial Lipids
NCT07313787 NOT_YET_RECRUITING PHASE2
Brain Fuel - Morning Nutrition and Cognitive Function
NCT03386396 ACTIVE_NOT_RECRUITING NA