Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06992544

Trial of Pistachio Consumption in Older Adults

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

65 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Pistachio-enriched diet

Other

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

Usual diet

Other

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

Primary outcomes

  1. Mobile Toolbox

    Time frame: Baseline and 6 months

    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.

Secondary outcomes

  1. Blood pressure

    Time frame: Baseline and 6 months

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

  2. Life Satisfaction for the Third Age-Short Form

    Time frame: Baseline and 6 months

    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.

  3. Shape-Color Sorting

    Time frame: Baseline and 6 months

    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. Raw rate scores may range from 0-10, in which a higher score indicates better cognitive flexibility.

  4. Arrow Matching

    Time frame: Baseline and 6 months

    The investigators will assess 6-month changes in the Mobile Toolbox "Arrow Matching" test as a measure of inhibitory control, 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. Raw rate scores may range from 0-10, in which a higher score indicates better inhibitory control.

  5. Faces and Names

    Time frame: Baseline and 6 months

    The investigators will assess 6-month changes in the Mobile Toolbox "Faces and Names" test as a measure of associative memory (individual cognitive domain). The test consists of one encoding phase and three memory phases: Face Recognition, Name Recall, and Name Recognition (possible score range for each: 0-12). Total raw scores may range from 0-36, in which a higher score indicates better associative memory.

  6. Body weight

    Time frame: Baseline and 6 months

    The investigators will assess 6-month changes in body weight (in kg).

  7. Lipid profile

    Time frame: Baseline and 6 months

    The investigators will assess 6-month changes in lipid profiles, including total cholesterol, low-density lipoprotein cholesterol (Friedewald calculated), high-density lipoprotein cholesterol, and triglycerides. All lipids will be reported as mg/dL.

  8. Fasting blood glucose

    Time frame: Baseline and 6 months

    The investigators will assess 6-month changes in fasting blood glucose (in mg/dL).

  9. Insulin-like growth factor-1

    Time frame: Baseline and 6 months

    The investigators will assess 6-month changes of insulin-like growth factor-1 in the blood (in ng/mL).

  10. Interleukin-6

    Time frame: Baseline and 6 months

    The investigators will assess 6-month changes of interleukin-6 in the blood (in pg/mL).

  11. Arranging Pictures

    Time frame: Baseline and 6 months

    The investigators will assess 6-month changes in the Mobile Toolbox "Arranging Pictures" test as a measure of episodic memory (individual cognitive domain). This test scores the sum of adjacent pairs correctly placed across two trials. Raw scores range from 0-26 (14 images results in a maximum of 13 adjacent pairs correct per trial), in which a higher score indicates better episodic memory.

  12. Sequences

    Time frame: Baseline and 6 months

    The investigators will assess 6-month changes in the Mobile Toolbox "Sequences" test as a measure of working memory (individual cognitive domain). This score is the total number of items (individual sequence) correctly answered. The possible raw score range is 0-30, in which a higher score indicates better working memory.

  13. Number-Symbol Match

    Time frame: Baseline and 6 months

    The investigators will assess 6-month changes in the Mobile Toolbox "Number-Symbol Match" test as a measure of processing speed (individual cognitive domain). The test includes 144 total items, with up to 16 successive screens of 9 items each presented, and examinees have 90 seconds to complete as many items as possible. This score is the total number of items correctly answered in 90 seconds. The possible raw score range is 0-144, in which a higher score indicates better processing speed.

  14. Waist circumference

    Time frame: Baseline and 6 months

    The investigators will assess 6-month changes in waist circumference (in cm).

Other outcomes

  1. Lutein

    Time frame: Baseline and 6 months

    The investigators will assess 6-month changes in serum lutein (in µmol/L) as a marker of compliance with pistachio consumption. Participants in the pistachio group are expected to have increases in serum lutein levels, while participants in the usual group are expected to have no changes.

  2. Gamma tocopherol

    Time frame: Baseline and 6 months

    The investigators will assess 6-month changes in serum gamma tocopherol (mg/L) as a marker of compliance with pistachio consumption. Participants in the pistachio group are expected to have increases in serum gamma tocopherol levels, while participants in the usual group are expected to have no changes.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • American Pistachio Growers
  • Boston Children's Hospital, Boston, MA, USA
  • Quest Diagnostics-Nichols Insitute
  • University of Illinois at Urbana-Champaign

Registry information

Official study title

Trial of Pistachio Consumption on Cognition, Cardiometabolic Risk Factors, and Life Satisfaction in Older Adults

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 28, 2025
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.