Clinical trial NCT06992544: Trial of Pistachio Consumption in Older Adults
Official title: Trial of Pistachio Consumption on Cognition, Cardiometabolic Risk Factors, and Life Satisfaction in Older Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cognition
Cardiometabolic Risk Factors
Life Satisfaction
Keywords: Pistachio
Cognition
Life satisfaction
Older adults
Cardiometabolic risk factors
Blood pressure
Biomarkers
Memory
Diet
Nut intake
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: American Pistachio Growers
name: Boston Children's Hospital, Boston, MA, USA
name: University of Illinois at Urbana-Champaign
name: Quest Diagnostics-Nichols Insitute
First posted: 2025-05-28
Enrollment: 80
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this study is to evaluate whether a pistachio-enriched diet leads to changes in cognitive function, cardiometabolic risk factors, and life satisfaction in older adults over a 6-month period.

Detailed description: In this remote-based, parallel-arm RCT, the investigators will recruit participants from the recently completed COcoa Supplement and Multivitamin Outcomes Study (COSMOS) trial cohort. Eligible COSMOS participants will be invited to participate in the proposed RCT, screened to verify eligibility and willingness to participate, and asked to provide informed consent. Eligible and willing participants will be enrolled and randomized on a rolling basis. Risk factors and Outcome assessments will be conducted at baseline, 3 months and 6 months via the MyCap Mobile Toolbox application, REDCap questionnaires (for life satisfaction, dietary, and other phenotypic assessments), or at a local Quest Diagnostics (for biospecimen collection and return to our biorepository).

Eligibility criteria: Inclusion Criteria:

1. Active participant in COSMOS
2. Current age 65 to 80 years

Exclusion Criteria:

1. Tree nut allergy
2. Current intake of peanuts, walnuts, or other nuts \>1 serving/week
3. Diagnosis of Alzheimer's disease or any other type of dementia
4. Diagnosis of cancer or CVD (MI, stroke, CABG, PTCA, or stent) within last 12 months
5. Changes in the dose or number of anti-hypertensive, lipid-lowering, or diabetic medications over the past 3 months prior to randomization
6. Does not own a smartphone or tablet
7. Unable or unwilling to abstain from pistachio intake for 6 months
8. Unable or unwilling to limit nut consumption to ≤1 serving/week for 6 months
9. Unable or unwilling to complete online questionnaires and cognitive assessments
10. Unable or unwilling to travel to a local Quest site for biospecimen collection
11. Unable or unwilling to provide consent to participate in the trial
12. Failure to complete the baseline Life Satisfaction Questionnaire
13. Failure to complete the baseline cognitive assessments
14. Failure to complete the baseline biospecimen collection

Primary outcomes:
measure: Mobile Toolbox
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Blood pressure
timeFrame: Baseline and 6 months
measure: Life Satisfaction for the Third Age-Short Form
timeFrame: Baseline and 6 months
measure: Shape-Color Sorting
timeFrame: Baseline and 6 months
measure: Arrow Matching
timeFrame: Baseline and 6 months
measure: Faces and Names
timeFrame: Baseline and 6 months
measure: Body weight
timeFrame: Baseline and 6 months
measure: Lipid profile
timeFrame: Baseline and 6 months
measure: Fasting blood glucose
timeFrame: Baseline and 6 months
measure: Insulin-like growth factor-1
timeFrame: Baseline and 6 months
measure: Interleukin-6
timeFrame: Baseline and 6 months
measure: Arranging Pictures
timeFrame: Baseline and 6 months
measure: Sequences
timeFrame: Baseline and 6 months
measure: Number-Symbol Match
timeFrame: Baseline and 6 months
measure: Waist circumference
timeFrame: Baseline and 6 months
Other outcomes:
measure: Lutein
timeFrame: Baseline and 6 months
measure: Gamma tocopherol
timeFrame: Baseline and 6 months
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
References: