Study Results
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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NOT_YET_RECRUITING
PHASE1/PHASE2
60 participants
INTERVENTIONAL
2026-01-15
2028-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Pecan
2.0 oz pecans daily for 3 months
Pecan snack
Pecan
Pretzel
3.5 oz pretzel snack daily for 3 months
Pretzel snack
Pretzel snack
Interventions
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Pecan snack
Pecan
Pretzel snack
Pretzel snack
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
ALL
No
Sponsors
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Texas Tech University Health Sciences Center
OTHER
Responsible Party
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB-FY2026-58
Identifier Type: -
Identifier Source: org_study_id
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