Snacks and Brain Health

NCT ID: NCT07348406

Last Updated: 2026-01-16

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

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-15

Study Completion Date

2028-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cognitive Assessment Psychological Function GI Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Pecan

2.0 oz pecans daily for 3 months

Group Type ACTIVE_COMPARATOR

Pecan snack

Intervention Type BIOLOGICAL

Pecan

Pretzel

3.5 oz pretzel snack daily for 3 months

Group Type PLACEBO_COMPARATOR

Pretzel snack

Intervention Type BIOLOGICAL

Pretzel snack

Interventions

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Pecan snack

Pecan

Intervention Type BIOLOGICAL

Pretzel snack

Pretzel snack

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Texas Tech University Health Sciences Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chwan-Li (Leslie) Shen, PhD

Role: PRINCIPAL_INVESTIGATOR

Texas Tech University Health Sciences Center School of Medicine

Locations

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Texas Tech University Health Sciences Center

Lubbock, Texas, United States

Site Status

Countries

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United States

Central Contacts

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Chwan-Li (Leslie) Shen, PhD

Role: CONTACT

806-743-2815

Facility Contacts

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Chadley Coperland

Role: primary

806-743-4752

Other Identifiers

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IRB-FY2026-58

Identifier Type: -

Identifier Source: org_study_id

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