Cognitive AssessmentPhase 1/2NCT07348406
Snacks and Brain Health
A Phase 1/2 study testing Pecan snack and Pretzel snack in people with Cognitive Assessment and Psychological Function, run by Texas Tech University Health Sciences Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cognitive Assessment, Psychological Function, GI Health
- What is being tested?
- Pecan snack and Pretzel snack
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2026to 30 Sep 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Texas Tech University Health Sciences Center
Lubbock, Texas, 79430
Chadley Coperland, 806-743-4752, Chadley.Copeland@ttuhsc.edu
About this study
Official title: Effects of Pecans on Brain Health in Older Americans With Mild Cognitive Impairment: Gut-brain Axis
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
- Being tested
- Pecan snack, Pretzel snack
- Keywords
- neuroinflammation, gut microbiome, fMRI
- Medical subject headings
- Neuroinflammatory Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pecan snackBiological
Pecan
Pretzel snackBiological
Pretzel snack
| Study group | Role | What they receive |
|---|---|---|
| Pecan | Active comparator | 2.0 oz pecans daily for 3 months Receives: Biological: Pecan snack |
| Pretzel | Placebo comparator | 3.5 oz pretzel snack daily for 3 months Receives: Biological: Pretzel snack |
What is being measured
The primary outcome is the main question the study is designed to answer.
fMRI measures
connectivity of amygdala seed regions and broader bilateral mPFC using fMRI
Measured: baseline and after 3 months
Secondary outcomes (11)
NACC Uniform Data Set
overall neurocognitive functioning
Measured: baseline and after 3 months
Wisconsin Card Sorting Test
Cognition
Measured: baseline and after 3 months
California Verbal Learning Test
Memory and verbal learning
Measured: baseline and after 3 months
Clock Draw Test
Visuospatial functioning
Measured: baseline and after 3 months
TRAILS A and B
neuropsychological function
Measured: baseline and after 3 months
Geriatric Depression Scale (GDS-15)
Depression assessment
Measured: baseline and after 3 months
Beck Anxiety Inventory (BAI)
Anxiety assessment
Measured: baseline and after 3 months
fecal zonulin concentration by ELISA
Intestinal permeability marker
Measured: baseline and after 3 months
gut microbiome
fecal microbiome composition using 16S RNA sequencing
Measured: baseline and after 3 months
fecal metabolites
untargeted fecal metabolites by LC-MS analysis
Measured: baseline and after 3 months
neuroinflammation gene
whole blood neuroinflammation gene profiles
Measured: baseline and after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start15 Mar 2026
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive AssessmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chwan-Li (Leslie) Shen, PhD, Principal investigator, Texas Tech University Health Sciences Center School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07348406
- Sponsor's protocol ID
- IRB-FY2026-58
- Status last verified
- Sep 2026
- First submitted
- 29 Dec 2025
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make IPD available due to HIPAA regulation.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pecans on Brain Health in Older Americans With Mild Cognitive Impairment: Gut-brain Axis
- ClinicalTrials.gov ID
- NCT07348406
- Acronym / sponsor ID
- IRB-FY2026-58
- Conditions
- Cognitive Assessment, Psychological Function, GI Health
- Keywords
- neuroinflammation, gut microbiome, fMRI
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Texas Tech University Health Sciences CenterUniversity, hospital or other
- Study start
- 15 Mar 2026 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pecan | Active comparator | Biological: Pecan snack2.0 oz pecans daily for 3 months |
| Pretzel | Placebo comparator | Biological: Pretzel snack3.5 oz pretzel snack daily for 3 months |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pecan snackPecan | Biological | Pecan |
| Pretzel snackPretzel snack | Biological | Pretzel |
Primary outcome
fMRI measures
Time frame: baseline and after 3 months
connectivity of amygdala seed regions and broader bilateral mPFC using fMRI
11 secondary outcomes
NACC Uniform Data Set
Time frame: baseline and after 3 months
Wisconsin Card Sorting Test
Time frame: baseline and after 3 months
California Verbal Learning Test
Time frame: baseline and after 3 months
Clock Draw Test
Time frame: baseline and after 3 months
TRAILS A and B
Time frame: baseline and after 3 months
Geriatric Depression Scale (GDS-15)
Time frame: baseline and after 3 months
Beck Anxiety Inventory (BAI)
Time frame: baseline and after 3 months
fecal zonulin concentration by ELISA
Time frame: baseline and after 3 months
gut microbiome
Time frame: baseline and after 3 months
fecal metabolites
Time frame: baseline and after 3 months
neuroinflammation gene
Time frame: baseline and after 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No. There is no plan to make IPD available due to HIPAA regulation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chwan-Li (Leslie) Shen, PhD principal investigator
Texas Tech University Health Sciences Center School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pecan snack and Pretzel snack in people with Cognitive Assessment and Psychological Function, run by Texas Tech University Health Sciences Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chwan-Li (Leslie) Shen, PhD (806-743-2815, leslie.shen@ttuhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fMRI measures (time frame: baseline and after 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.