Snacks and Brain Health
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age50+
SponsorTexas Tech University Health Sciences Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Pecan snack
Biological/VaccinePecan
Pretzel snack
Biological/VaccinePretzel snack
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: PecanActive comparator 1 intervention
Group B: PretzelPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
fMRI measures
connectivity of amygdala seed regions and broader bilateral mPFC using fMRI
Time frame
baseline and after 3 monthsSecondary outcomes
1
NACC Uniform Data Set
overall neurocognitive functioning
Time frame
baseline and after 3 months2
Wisconsin Card Sorting Test
Cognition
Time frame
baseline and after 3 months3
California Verbal Learning Test
Memory and verbal learning
Time frame
baseline and after 3 months4
Clock Draw Test
Visuospatial functioning
Time frame
baseline and after 3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov