Trial of Pistachio Consumption in Older Adults

NCT06992544 | Active Not Recruiting

• 1 other identifier: 2024P002479
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognition; Cardiometabolic Risk Factors; Life Satisfaction

Keywords

Pistachio; Cognition; Life satisfaction; Older adults; Cardiometabolic risk factors; Blood pressure; Biomarkers; Memory; Diet; Nut intake

Outcome Measures

Primary Outcomes (1)

• Mobile Toolbox

  The investigators will assess 6-month changes in the Mobile Toolbox (MTB) fluid cognition composite (FCC) score via MyCap. Participants will be instructed to install the MyCap app on their personal smartphones to complete the assessments. The FCC score considers the following domains (tests): associative memory (Face and Names), episodic memory (Arranging Pictures), working memory (Sequences), processing speed (Number-Symbol Match), and executive function (Arrow Matching for inhibitory control, Shape-Color Sorting for cognitive flexibility). The FCC score will be calculated by standardizing scores for each MTB test using means and standard deviations (SD) across the entire sample and averaging z-scores across the six tests (mean=0; SD=1). Higher FCC scores will indicate better cognitive function.

  Baseline and 6 months

Secondary Outcomes (14)

• Blood pressure

  Baseline and 6 months

• Life Satisfaction for the Third Age-Short Form

  Baseline and 6 months

• Shape-Color Sorting

  Baseline and 6 months

• Arrow Matching

  Baseline and 6 months

• Faces and Names

  Baseline and 6 months

Other Outcomes (2)

• Lutein

  Baseline and 6 months

• Gamma tocopherol

  Baseline and 6 months

Study Arms (2)

Pistachio-enriched diet

ACTIVE COMPARATOR

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

Other: Pistachio-enriched diet

Usual diet

OTHER

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

Other: Usual diet

Interventions

Pistachio-enriched diet OTHER

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

Pistachio-enriched diet

Usual diet OTHER

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

Usual diet

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• American Pistachio Growers: collaborator
• Boston Children's Hospital, Boston, MA, USA: collaborator
• University of Illinois at Urbana-Champaign: collaborator
• Quest Diagnostics-Nichols Insitute: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• Park SJ, Gavilan IS, Li S, Clar A, Lau J, Karbowski GC, Sarkissian AA, Camara M, Sesso HD. Effects of pistachio consumption on cognition, cardiometabolic risk factors, and life satisfaction in older adults: Protocol for a remote-based randomized controlled trial. Contemp Clin Trials. 2026 Jun;165:108316. doi: 10.1016/j.cct.2026.108316. Epub 2026 Apr 15.

  PMID: 41991057 DERIVED

MeSH Terms

Conditions

Personal Satisfaction

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Outcome assessments will be blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Epidemiologist

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 28, 2025
• Study Start: May 28, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: June 3, 2026

Record last verified: 2026-06

Locations

US (1)