Pistachio-Enriched Diet for Cognition and Heart Health

Overseen By Howard D Sesso, ScD, MPH

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Disqualifiers: Tree nut allergy, Dementia, Cancer, CVD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 6 months

80 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for active COSMOS participants aged 65 to 80 who can limit nut intake, avoid pistachios for 6 months, and are free from recent changes in certain medications. Excluded are those with tree nut allergies, recent severe illnesses like cancer or heart disease, dementia diagnoses, or an inability to complete assessments.

Inclusion Criteria

Active participant in COSMOS

I am between 65 and 80 years old.

Exclusion Criteria

My medications for blood pressure, cholesterol, or diabetes haven't changed in the last 3 months.

I cannot or will not stop eating pistachios for 6 months.

Tree nut allergy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Remote screening

Treatment

Participants consume a pistachio-enriched diet or maintain their usual diet over a 6-month period

6 months

Baseline, 3 months, and 6 months assessments

Follow-up

Participants are monitored for changes in cognitive function, cardiometabolic risk factors, and life satisfaction

4 weeks

Remote follow-up assessments

Treatment Details

Interventions

• Pistachio-enriched diet

Trial Overview The study compares the effects of a pistachio-enriched diet versus a usual diet on cognitive function, cardiometabolic health, and life satisfaction among older adults over six months. Participants will be randomly assigned to one of the two diets.

Participant Groups

Group I: Usual diet Experimental Treatment 1 Intervention

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

Group II: Pistachio-enriched diet Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Boston Children's Hospital, Boston, MA, USA

Collaborator

Trials

4

Recruited

2,600+

Quest Diagnostics-Nichols Insitute

Industry Sponsor

Trials

14

Recruited

26,500+

American Pistachio Growers

Collaborator

Trials

6

Recruited

320+

University of Illinois at Urbana-Champaign

Collaborator

Trials

203

Recruited

40,600+