Snacks and Brain Health (NCT07348406) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Snacks and Brain Health
United States60 participantsStarted 2026-05-15
Plain-language 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.
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 tes…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
fMRI measures
Timeframe: baseline and after 3 months
Trial details
NCT IDNCT07348406
SponsorTexas Tech University Health Sciences Center