Snacks and Brain Health

NCT07348406 | Not Yet Recruiting Phase 1

• 1 other identifier: IRB-FY2026-58
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cognitive Assessment; Psychological Function; GI Health

Keywords

neuroinflammation; gut microbiome; fMRI

Outcome Measures

Primary Outcomes (1)

• fMRI measures

  connectivity of amygdala seed regions and broader bilateral mPFC using fMRI

  baseline and after 3 months

Secondary Outcomes (11)

• NACC Uniform Data Set

  baseline and after 3 months

• Wisconsin Card Sorting Test

  baseline and after 3 months

• California Verbal Learning Test

  baseline and after 3 months

• Clock Draw Test

  baseline and after 3 months

• TRAILS A and B

  baseline and after 3 months

Study Arms (2)

Pecan

ACTIVE COMPARATOR

2.0 oz pecans daily for 3 months

Biological: Pecan snack

Pretzel

PLACEBO COMPARATOR

3.5 oz pretzel snack daily for 3 months

Biological: Pretzel snack

Interventions

Pecan snack BIOLOGICAL

Pecan

Pecan

Pretzel snack BIOLOGICAL

Pretzel snack

Pretzel

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas Tech University Health Sciences Center: lead

Study Sites (1)

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

Location

MeSH Terms

Conditions

Neuroinflammatory Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chwan-Li (Leslie) Shen, PhD

  Texas Tech University Health Sciences Center School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chwan-Li (Leslie) Shen, PhD

CONTACT

806-743-2815; leslie.shen@ttuhsc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: January 16, 2026
• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)