CognitionNCT06992544
Trial of Pistachio Consumption in Older Adults
A study testing Pistachio-enriched diet and Usual diet in people with Cognition and Cardiometabolic Risk Factors, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognition, Cardiometabolic Risk Factors, Life Satisfaction
- What is being tested?
- Pistachio-enriched diet and Usual diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2025to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02215
About this study
Official title: Trial of Pistachio Consumption on Cognition, Cardiometabolic Risk Factors, and Life Satisfaction 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.
Read the 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).
- Conditions
- Cognition, Cardiometabolic Risk Factors, Life Satisfaction
- Being tested
- Pistachio-enriched diet, Usual diet
- Keywords
- Pistachio, Cognition, Life satisfaction, Older adults, Cardiometabolic risk factors, Blood pressure, Biomarkers, Memory, Diet, Nut intake
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| Pistachio-enriched diet | Active comparator | 1 packet/day of approximately 1.25 oz (35 g) of dry roasted, unsalted, shelled pistachio kernels Receives: Other: Pistachio-enriched diet |
| Usual diet | Other | Usual diet (while abstaining from pistachio consumption and limiting other nut consumption to ≤1 serving/week) Receives: Other: Usual diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 months
Secondary outcomes (14)
Blood pressure
The investigators will assess 6-month changes in seated systolic and diastolic blood pressure (in mmHg).
Measured: 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.
Measured: 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. Raw rate scores may range from 0-10, in which a higher score indicates better cognitive flexibility.
Measured: Baseline and 6 months
Arrow Matching
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.
Measured: Baseline and 6 months
Faces and Names
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.
Measured: Baseline and 6 months
Body weight
The investigators will assess 6-month changes in body weight (in kg).
Measured: Baseline and 6 months
Lipid profile
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.
Measured: Baseline and 6 months
Fasting blood glucose
The investigators will assess 6-month changes in fasting blood glucose (in mg/dL).
Measured: Baseline and 6 months
Insulin-like growth factor-1
The investigators will assess 6-month changes of insulin-like growth factor-1 in the blood (in ng/mL).
Measured: Baseline and 6 months
Interleukin-6
The investigators will assess 6-month changes of interleukin-6 in the blood (in pg/mL).
Measured: Baseline and 6 months
Arranging Pictures
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.
Measured: Baseline and 6 months
Sequences
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.
Measured: Baseline and 6 months
Number-Symbol Match
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.
Measured: Baseline and 6 months
Waist circumference
The investigators will assess 6-month changes in waist circumference (in cm).
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start28 May 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CognitionStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- American Pistachio Growers, Boston Children's Hospital, Boston, MA, USA, University of Illinois at Urbana-Champaign, Quest Diagnostics-Nichols Insitute
- Responsible party
- Principal investigator, Howard D. Sesso, ScD, MPH, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06992544
- Sponsor's protocol ID
- 2024P002479
- Status last verified
- Nov 2026
- First submitted
- 29 Apr 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 41991057
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Pistachio Consumption on Cognition, Cardiometabolic Risk Factors, and Life Satisfaction in Older Adults
- ClinicalTrials.gov ID
- NCT06992544
- Acronym / sponsor ID
- 2024P002479
- Conditions
- Cognition, Cardiometabolic Risk Factors, Life Satisfaction
- Keywords
- Pistachio, Cognition, Life satisfaction, Older adults, Cardiometabolic risk factors, Blood pressure, Biomarkers, Memory
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- American Pistachio Growers, Boston Children's Hospital, Boston, MA, USA, University of Illinois at Urbana-Champaign, Quest Diagnostics-Nichols Insitute
- Study start
- 28 May 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 28 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pistachio-enriched diet | Active comparator | Other: Pistachio-enriched diet1 packet/day of approximately 1.25 oz (35 g) of dry roasted, unsalted, shelled pistachio kernels |
| Usual diet | Other | Other: Usual dietUsual diet (while abstaining from pistachio consumption and limiting other nut consumption to ≤1 serving/week) |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pistachio-enriched diet1 packet/day of approximately 1.25 oz (35 g) of dry roasted, unsalted, shelled pistachio kernels | Other | Pistachio-enriched diet |
| Usual dietUsual diet (while abstaining from pistachio consumption and limiting other nut consumption to ≤1 serving/week) | Other | Usual diet |
Primary outcome
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.
14 secondary outcomes
Blood pressure
Time frame: Baseline and 6 months
Life Satisfaction for the Third Age-Short Form
Time frame: Baseline and 6 months
Shape-Color Sorting
Time frame: Baseline and 6 months
Arrow Matching
Time frame: Baseline and 6 months
Faces and Names
Time frame: Baseline and 6 months
Body weight
Time frame: Baseline and 6 months
Lipid profile
Time frame: Baseline and 6 months
Fasting blood glucose
Time frame: Baseline and 6 months
Insulin-like growth factor-1
Time frame: Baseline and 6 months
Interleukin-6
Time frame: Baseline and 6 months
Arranging Pictures
Time frame: Baseline and 6 months
Sequences
Time frame: Baseline and 6 months
Number-Symbol Match
Time frame: Baseline and 6 months
Waist circumference
Time frame: Baseline and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Derived from this study: PubMed 41991057Park 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pistachio-enriched diet and Usual diet in people with Cognition and Cardiometabolic Risk Factors, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mobile Toolbox (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06992544, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.