Trial of Pistachio Consumption in Older Adults

Mass General Brigham

Status: Active, not recruiting

Conditions: Cardiometabolic Risk Factors; Cognition; Life Satisfaction

Treatments: Other: Pistachio-enriched diet; Other: Usual diet

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06992544

2024P002479

Details and patient eligibility

About

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.

Full 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).

Enrollment: 97 patients

Sex: All

Ages: 65 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Active participant in COSMOS
2. Current age 65 to 80 years
3. Does not reside in the states of Arizona, Hawaii, or Wyoming (since Quest Diagnostics does not have locations in these states)

Exclusion criteria

1. Tree nut allergy
2. Current intake of pistachios, 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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97 participants in 2 patient groups

Pistachio-enriched diet

Active Comparator group

Description:

1 packet/day of approximately 1.25 oz (35 g) of dry roasted, unsalted, shelled pistachio kernels

Treatment:

Other: Pistachio-enriched diet

Usual diet

Other group

Description:

Usual diet (while abstaining from pistachio consumption and limiting other nut consumption to ≤1 serving/week)

Treatment:

Other: Usual diet