ClinicalTrials.gg
Sign In
RecruitingNCT07348406Updated Sep 8, 2026

Snacks and Brain Health

A Phase 1/2 interventional study of Pecan snack and Pretzel snack in Cognitive Assessment, Psychological Function and GI Health, sponsored by Texas Tech University Health Sciences Center. Recruiting at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.

Sponsored by Texas Tech University Health Sciences Center · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2026; still recruiting 7 months later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cognitive Assessment
  • Psychological Function
  • GI Health

Keywords

  • neuroinflammation
  • gut microbiome
  • fMRI
03

In context

Neuroinflammatory Diseases

180 studies on the registry are indexed under Neuroinflammatory Diseases; 80 are open to participants now.

This study's planned enrollment of 60 is above the median of 44 across 113 interventional studies indexed under Neuroinflammatory Diseases.

Browse Neuroinflammatory Diseases studies →

Lead sponsor

Texas Tech University Health Sciences Center is the lead sponsor of 100 studies on the registry; 14 are open to participants now.

Browse Texas Tech University Health Sciences Center studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Pecan

    2.0 oz pecans daily for 3 months

    Biological: Pecan snack

  • Placebo comparator
    Pretzel

    3.5 oz pretzel snack daily for 3 months

    Biological: Pretzel snack

Interventions

  • BiologicalPecan snack

    Pecan

  • BiologicalPretzel snack

    Pretzel snack

06

What researchers measure

Primary outcomes

  1. fMRI measures

    connectivity of amygdala seed regions and broader bilateral mPFC using fMRI

    Time frame: baseline and after 3 months

Secondary outcomes

  1. NACC Uniform Data Set

    overall neurocognitive functioning

    Time frame: baseline and after 3 months

  2. Wisconsin Card Sorting Test

    Cognition

    Time frame: baseline and after 3 months

  3. California Verbal Learning Test

    Memory and verbal learning

    Time frame: baseline and after 3 months

  4. Clock Draw Test

    Visuospatial functioning

    Time frame: baseline and after 3 months

  5. TRAILS A and B

    neuropsychological function

    Time frame: baseline and after 3 months

  6. Geriatric Depression Scale (GDS-15)

    Depression assessment

    Time frame: baseline and after 3 months

  7. Beck Anxiety Inventory (BAI)

    Anxiety assessment

    Time frame: baseline and after 3 months

  8. fecal zonulin concentration by ELISA

    Intestinal permeability marker

    Time frame: baseline and after 3 months

  9. gut microbiome

    fecal microbiome composition using 16S RNA sequencing

    Time frame: baseline and after 3 months

  10. fecal metabolites

    untargeted fecal metabolites by LC-MS analysis

    Time frame: baseline and after 3 months

  11. neuroinflammation gene

    whole blood neuroinflammation gene profiles

    Time frame: baseline and after 3 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — There is no plan to make IPD available due to HIPAA regulation.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2026 (actual). Primary completion is estimated for Sep 2028, 30 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 29, 2025
First posted
Jan 16, 2026
StartActual
Mar 15, 2026
Primary completionEst.
Sep 30, 2028
CompletionEst.
Sep 30, 2028
Last update
Sep 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07348406
Lead sponsor
Texas Tech University Health Sciences Center
Responsible party
Sponsor
First posted
Jan 16, 2026
Start date
Mar 15, 2026
Primary completion
Sep 30, 2028 (estimated)
Completion
Sep 30, 2028 (estimated)
Last update
Sep 8, 2026

Study contacts

Chwan-Li (Leslie) Shen, PhD
Contact
leslie.shen@ttuhsc.edu
806-743-2815
Chwan-Li (Leslie) Shen, PhD
principal investigator · Texas Tech University Health Sciences Center School of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Neuroinflammatory Diseases →

Other studies from this sponsor

Texas Tech University Health Sciences Center →

Start the discussion