Snacks and Brain Health
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pecan snack, Pretzel snack.
- Who it may be relevant to
- Registry conditions: Cognitive Assessment, Psychological Function, GI Health. Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effects of Pecans on Brain Health in Older Americans With Mild Cognitive Impairment: Gut-brain Axis
Overview
This project will investigate whether daily snack consumption can improve memory, mood, and overall brain function in people with cognitive impairment. Sixty participants, aged 50 and older, with cognitive impairment, will be randomly assigned to eat snacks, either pecans or pretzels, for three months. Researchers will also study how snacks (pecans and pretzels) may influence the body, including changes in gut bacteria, blood markers of inflammation, and signals that connect the gut and the brain.
Interventions
- Biological Pecan snack
Pecan - Biological Pretzel snack
Pretzel snack
Primary outcome measures
- fMRI measures [Time frame: baseline and after 3 months]
Secondary outcome measures (11)
- NACC Uniform Data Set [Time frame: baseline and after 3 months]
- Wisconsin Card Sorting Test [Time frame: baseline and after 3 months]
- California Verbal Learning Test [Time frame: baseline and after 3 months]
- Clock Draw Test [Time frame: baseline and after 3 months]
- TRAILS A and B [Time frame: baseline and after 3 months]
- Geriatric Depression Scale (GDS-15) [Time frame: baseline and after 3 months]
- Beck Anxiety Inventory (BAI) [Time frame: baseline and after 3 months]
- fecal zonulin concentration by ELISA [Time frame: baseline and after 3 months]
- gut microbiome [Time frame: baseline and after 3 months]
- fecal metabolites [Time frame: baseline and after 3 months]
- neuroinflammation gene [Time frame: baseline and after 3 months]
Eligibility criteria
Inclusion criteria
- men and women > 50 years-old
- self-reported IQCODE (informant questionnaire on cognitive decline in the elderly) average score < 4.5
- self-reported significant functional impairment (related to cognitive impairment) in basic or advanced activities of daily living as evidenced by the Activities of Daily Living (ADLs) questionnaire. If answers to at least one endorsement in the "NO, dependence due to memory concerns".
- Stable medications (≥ 12-week unchanged dose before baseline) with no planned changes during trial.
- habitually consume less than two servings (2 ozs = 1/4 cup) of nuts or nut spreads per week
- willing to accept randomization
Exclusion criteria
- reported nut allergy or intolerance
- self-reported untreated hypothyroidism, severe liver disease, or end-stage chronic kidney disease
- heavy alcohol drinker: in the past 3 months: men ≥14 drinks/week or women ≥7 drinks/week
- recent (<1 month) appearance of diarrhea or hematochezia before study intervention begins. Rationale: A one-month waiting period after diarrhea or hematochezia (blood in stool) is recommended for a gut microbiome test to ensure the results accurately reflect the state and microbial composition, since diarrhea and hematochezia can significantly alter the gut environment and skew test results.
- recent (<1 month) exposure to antibiotics before study intervention begins. Rationale: A one-month waiting period after antibiotics is recommended for a gut microbiome test because it allows the microbial community time to recover and reach a more stable state, ensuring a more accurate and representative snapshot of the gut microbiome composition, since antibiotic usage can significantly reduce microbial diversity.
- Self-reported unstable GI disorder
- likeliness of moving during the trial, lack of transportation, or unavailability at sample collection times
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Texas Tech University Health Sciences Center — Lubbock
Identifiers
NCT: NCT07348406 · IRB-FY2026-58