Trial of Pistachio Consumption in Older Adults
Purpose
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.
Conditions
- Cognition
- Cardiometabolic Risk Factors
- Life Satisfaction
Eligibility
- Eligible Ages
- Between 65 Years and 80 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Active participant in COSMOS 2. Current age 65 to 80 years
Exclusion Criteria
- 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- None (Open Label)
- Masking Description
- Outcome assessments will be blinded.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Pistachio-enriched diet |
1 packet/day of approximately 1.25 oz (35 g) of dry roasted, unsalted, shelled pistachio kernels |
|
|
Other Usual diet |
Usual diet (while abstaining from pistachio consumption and limiting other nut consumption to ≤1 serving/week) |
|
Recruiting Locations
Boston, Massachusetts 02215
More Details
- Status
- Recruiting
- Sponsor
- Brigham and Women's Hospital
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).