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NCT Number: NCT07348406

Snacks and Brain Health

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

Location contact

Chadley Coperland

CONTACT

[email protected]

806-743-4752

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pecan snack

Biological

Pecan

Pretzel snack

Biological

Pretzel snack

Primary outcomes

  1. fMRI measures

    Time frame: baseline and after 3 months

    connectivity of amygdala seed regions and broader bilateral mPFC using fMRI

Secondary outcomes

  1. NACC Uniform Data Set

    Time frame: baseline and after 3 months

    overall neurocognitive functioning

  2. Wisconsin Card Sorting Test

    Time frame: baseline and after 3 months

    Cognition

  3. California Verbal Learning Test

    Time frame: baseline and after 3 months

    Memory and verbal learning

  4. Clock Draw Test

    Time frame: baseline and after 3 months

    Visuospatial functioning

  5. TRAILS A and B

    Time frame: baseline and after 3 months

    neuropsychological function

  6. Geriatric Depression Scale (GDS-15)

    Time frame: baseline and after 3 months

    Depression assessment

  7. Beck Anxiety Inventory (BAI)

    Time frame: baseline and after 3 months

    Anxiety assessment

  8. fecal zonulin concentration by ELISA

    Time frame: baseline and after 3 months

    Intestinal permeability marker

  9. gut microbiome

    Time frame: baseline and after 3 months

    fecal microbiome composition using 16S RNA sequencing

  10. fecal metabolites

    Time frame: baseline and after 3 months

    untargeted fecal metabolites by LC-MS analysis

  11. neuroinflammation gene

    Time frame: baseline and after 3 months

    whole blood neuroinflammation gene profiles

Study contacts

Contact information is provided by the study sponsor or research team.

Chwan-Li (Leslie) Shen, PhD

CONTACT

[email protected]

806-743-2815

Sponsors and collaborators

Lead sponsor

Texas Tech University Health Sciences Center

Other

Registry information

Official study title

Effects of Pecans on Brain Health in Older Americans With Mild Cognitive Impairment: Gut-brain Axis

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 16, 2026
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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