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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding pistachios to the diet can improve brain function, heart health, and overall life happiness in older adults. Participants in one group will eat a small packet of pistachios daily, while another group will maintain their usual diet but avoid pistachios and limit other nuts. The study seeks individuals aged 65 to 80 who do not have a nut allergy and have not experienced recent heart problems or major changes in certain medications.

As an unphased trial, this study provides a unique opportunity to contribute to research that may enhance the quality of life in older adults.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you've changed the dose or number of certain medications like those for blood pressure, cholesterol, or diabetes in the last 3 months, you may not be eligible to participate.

What prior data suggests that a pistachio-enriched diet is safe for older adults?

Studies have shown that adding pistachios to the diet is generally safe and beneficial for health. Research suggests that including pistachios in a moderate-fat diet can slightly improve heart health in adults with well-managed type 2 diabetes. One study found that eating pistachios significantly lowered LDL cholesterol, often known as "bad" cholesterol, when part of a heart-healthy diet. These findings indicate that pistachios can be a safe and beneficial addition to the diet, particularly for heart health. No major negative effects have been reported in these studies, making pistachios a safe choice for most people. However, it's important to consider individual dietary needs and consult a healthcare provider if there are any concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about a pistachio-enriched diet because it offers a natural and tasty approach to boosting cognition and heart health. Unlike traditional treatments that often involve medications, this diet uses pistachios, which are packed with nutrients like healthy fats, fiber, and antioxidants. The unique combination of these nutrients may enhance brain function and support cardiovascular wellness in a way that is both enjoyable and sustainable. Plus, incorporating pistachios into one's diet could provide a simple lifestyle change with potentially big health benefits.

What evidence suggests that a pistachio-enriched diet could be effective for cognition and heart health?

Research has shown that adding pistachios to the diet might benefit health. In this trial, one group will follow a pistachio-enriched diet, consuming 1 packet per day of approximately 1.25 oz (35 g) of dry roasted, unsalted, shelled pistachio kernels. Studies have found that eating pistachios can benefit the heart by lowering cholesterol. For adults with type 2 diabetes, this diet has slightly improved heart-related issues. Early results also suggest that pistachios might boost brain function and mood. Promising evidence indicates that regularly eating pistachios may support both brain and heart health. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06992544

Trial of Pistachio Consumption in Older Adults This study evaluates if a pistachio-enriched diet affects cognitive function, cardiometabolic risk factors, and life satisfaction in older adults over 6 months.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7222408/

Regular Intake of Pistachio Mitigates the Deleterious Effects of ... Recent data showed that pistachio consumption is able to prevent and ameliorate dyslipidemia, hepatic steatosis, systemic and adipose tissue inflammation in ...

3. ahajournals.org ahajournals.org/doi/10.1161/jaha.114.000873

Pistachio Nut Consumption Modifies Systemic ... A moderate‐fat diet containing pistachios modestly improves some cardiovascular risk factors in adults with well‐controlled type 2 diabetes.

4. americanpistachios.org americanpistachios.org/research-archives/pistachios-heart-health-research

Pistachio & Heart Health Research These studies suggest that eating pistachios daily (one to three ounces or as 10%-20% of calories) may help to improve heart health in five ways.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0308814624018612

Pistachio (Pistacia vera L.) consumption improves ... This pilot study evaluated the impact of pistachio consumption on cognitive performance and mood in overweight young adults.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4310367/

Pistachio Nut Consumption Modifies Systemic ... A moderate‐fat diet containing pistachios modestly improves some cardiovascular risk factors in adults with well‐controlled type 2 diabetes.

7. withpower.com withpower.com/trial/phase-cognition-4-2025-8a093

Pistachio-Enriched Diet for Cognition and Heart Health The goal of this study is to evaluate whether a pistachio-enriched diet leads to changes in cognitive function, cardiometabolic risk factors, and life ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0002916523241581

Effects of pistachios on cardiovascular disease risk factors ... This study was the first to report significant reductions in LDL cholesterol after consumption of pistachios. In the context of a heart-healthy diet, we showed ...

9. americanpistachios.org americanpistachios.org/sites/default/files/inline-files/Health-and-Nutrition-Research-Brochure.pdf

Health and Nutrition Research Researchers concluded that a diet containing pistachios may improve the cardiometabolic profile of those with metabolic syndrome. Recently, three additional ...