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NCT Number: NCT07218822

Impact of Pistachio Consumption on Sleep

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.

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Key information

Conditions

Poor Quality Sleep

Age range

45 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Irving Medical Center

New York, 10032, United States

Location status: Recruiting

Location contact

Marie-Pierre St-Onge

PRINCIPAL_INVESTIGATOR

Marie-Pierre St-Onge, PhD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Pistachio

Dietary Supplement

2 servings/day for 4 weeks (56 g total/day)

Control food

Dietary Supplement

Muffins and cookies (no nuts), at an equivalent number of calories as the pistachio intervention, daily

Primary outcomes

  1. 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.

  2. 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.

  3. 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).

Secondary outcomes

  1. Sleep efficiency

    Time frame: 4 weeks

    Percent of time in bed spent asleep from wrist actigraphy

  2. Sleep depth

    Time frame: 4 weeks

    Time spent in deep sleep from home sleep test

  3. 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. 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.

Other outcomes

  1. Gut microbial diversity

    Time frame: 4 weeks

    Shannon index of alpha-diversity

  2. Polyphenols

    Time frame: 4 weeks

    Total amount of polyphenols present in urine collected overnight

  3. Polyphenol subtypes

    Time frame: 4 weeks

    Amount of each polyphenol subtype detected in urine collected overnight

Study contacts

Contact information is provided by the study sponsor or research team.

Diane Hawkins

CONTACT

[email protected]

347-963-8845

Joseariel Romero

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • American Pistachio Growers

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 20, 2025
Registry last updated
Feb 13, 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.

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