Trial of Pistachio Consumption in Older Adults

N/AActive Not RecruitingNCT06992544

Brigham and Women's Hospital97 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Cognition Cardiometabolic Risk Factors Life Satisfaction

Interventions

Pistachio-enriched dietOTHER

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

Usual dietOTHER

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

Eligibility

Sex: ALLMin age: 65 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Brigham and Women's Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Mobile Toolbox

The investigators will assess 6-month changes in the Mobile Toolbox total score as a measure of global cognitive function. The total score considers the following individual cognitive domains (tests): associative memory (Face and Names), executive function (Arrow Matching for inhibitory control, Shape-Color Sorting for cognitive flexibility), episodic memory (Arranging Pictures), working memory (Sequences), and processing speed (Number-Symbol Match). A total score is calculated by adding together each individual test score, for a total of 232 possible points. Scores may range from 0-232, in which a higher score indicates better cognitive function.

Time frame: Baseline and 6 months

Secondary Outcomes

Blood pressure

The investigators will assess 6-month changes in seated systolic and diastolic blood pressure (in mmHg).

Time frame: Baseline and 6 months

Life Satisfaction for the Third Age-Short Form

The investigators will assess 6-month changes in total score for the "Life Satisfaction for the Third Age-Short Form" questionnaire, a validated self-rated 12-item assessment of successful aging and psychological well-being among older adults. Participants will be instructed to select an answer that most closely reflect their attitude towards each statement on a Likert scale from 1 (strongly disagree) to 6 (strongly agree). Scores may range from 6-72, in which a higher score indicates greater life satisfaction.

Time frame: Baseline and 6 months

Shape-Color Sorting

The investigators will assess 6-month changes in the Mobile Toolbox "Shape-Color Sorting" test as a measure of cognitive flexibility, a component of executive function (individual cognitive domain). Participants are primary scored on rate correct per second, using the number of correct trials per second as a derived score. Scores may range from 0-10, in which a higher score indicates better cognitive flexibility.

Time frame: Baseline and 6 months

Data from ClinicalTrials.gov

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