Impact of Pistachio Consumption on Sleep

February 11, 2026 updated by: Marie-Pierre St-Onge, Columbia University
Sleep is essential for life and overall health. Unfortunately, a large portion of the population in the U.S. and worldwide experience sleep deficiencies, which increase their risk for developing chronic diseases. These sleep difficulties often cause distress, leading individuals to seek various forms of treatment. Given that some drugs cause habituation and undesirable side effects, individuals often turn to over-the-counter sleep remedies. However, long-term use of over-the-counter treatments is not recommended by the American Academy of Sleep Medicine for insomnia treatment and there is currently no recommendation related to dietary management. There is a strong need to identify natural measures to improve sleep in millions of adults battling poor sleep. Diet is emerging as a potentially important modulator of sleep. Despite observational data linking greater nut intake with better sleep, and that pistachios contain a significant number of sleep-promoting compounds, no study to date has evaluated the impact of pistachio supplementation on sleep. To address this key knowledge gap, the investigators propose to conduct a randomized controlled trial to evaluate the impact of pistachio consumption, relative to a calorie-matched control food, on sleep in middle-aged adults with poor sleep and to explore underlying mechanisms.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Irving Medical Center
        • Contact:
        • Principal Investigator:
          • Marie-Pierre St-Onge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Poor sleep quality, Pittsburgh Sleep Quality Index score >5
  • BMI 20 - 29.9 kg/m^2
  • Ability to abstain from travel across time zones
  • Willingness to eat study foods
  • Willingness/ability to discontinue use of vitamin and mineral supplements

Exclusion Criteria:

  • Premenopausal women

  • Medical or living conditions that could affect sleep:

    • Smoking
    • Excessive caffeine intake (>300 mg/day)
    • Non-day shift work
    • Chronic pain
    • Diagnosis of a chronic disease (e.g., uncontrolled hypertension, pre-diabetes, type 2 diabetes, chronic kidney disease, chronic obstructive pulmonary disease)
  • Autoimmune diseases, cardiovascular event or cancer in the past 24 months
  • Psychiatric/neurologic disease or disorder, or sleep disorder (diagnosed or high risk for sleep apnea, chronic insomnia, restless leg syndrome, narcolepsy)
  • Allergy or intolerance to nuts or study foods
  • Use of medications that influence CYP1A2 and selective serotonin reuptake inhibitors

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Pistachio
During the experimental (pistachio) intervention period, participants will be given 2 servings of pistachios (28 g each) to consume once in the morning (within 3 hours of wake time) and once in the evening (3-6 hours before bedtime) every day.
Dietary supplement: Pistachio
2 servings/day for 4 weeks (56 g total/day)
Placebo Comparator: Control
During the control food intervention period, participants will be given muffins and cookies (one serving each/day) to be consumed once in the morning (within 3 hours of wake time) and once in the evening (3-6 hours before bedtime) every day.
Dietary supplement: Control food
Muffins and cookies (no nuts), at an equivalent number of calories as the pistachio intervention, daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Self-reported sleep quality
Time Frame: 4 weeks
Self-reported sleep quality will be reported by the score on the Pittsburgh Sleep Quality Index. The full score range is 0 to 21, where a higher score indicates worse sleep quality.
4 weeks
Objective sleep quality
Time Frame: 4 weeks
Sleep fragmentation index assessed by wrist actigraphy. This is a measure of how frequently sleep is interrupted, calculated as the sum of the percentage of all scored epochs with one or more activity counts during time in bed and percentage of one-minute periods of sleep vs all periods of sleep during the sleep period.
4 weeks
Overnight melatonin production
Time Frame: 4 weeks
Amount of 6-sulfatoxymelatonin present in urine collected overnight, reported as ng/mg creatinine (corrected for creatinine content).
4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sleep efficiency
Time Frame: 4 weeks
Percent of time in bed spent asleep from wrist actigraphy
4 weeks
Sleep depth
Time Frame: 4 weeks
Time spent in deep sleep from home sleep test
4 weeks
Sleepiness
Time Frame: 4 weeks
Sleepiness will be reported by the score on the Epworth Sleepiness Scale. The full score range is 0 - 10, where a higher score indicates greater sleepiness.
4 weeks
Insomnia symptoms
Time Frame: 4 weeks
Insomnia symptoms will be assessed using the Insomnia Severity Index. The full score range is 0 - 28, where a higher score indicates more severe insomnia.
4 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gut microbial diversity
Time Frame: 4 weeks
Shannon index of alpha-diversity
4 weeks
Polyphenols
Time Frame: 4 weeks
Total amount of polyphenols present in urine collected overnight
4 weeks
Polyphenol subtypes
Time Frame: 4 weeks
Amount of each polyphenol subtype detected in urine collected overnight
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Columbia University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
American Pistachio Growers

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marie-Pierre St-Onge, Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 12, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 16, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 20, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AAAV9510

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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