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.

Study Overview

• Status: Recruiting
• Conditions: Poor Quality Sleep
• Intervention / Treatment: Dietary supplement: Pistachio; Dietary supplement: Control food

• Study Type: Interventional
• Enrollment (Estimated): 28
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Diane Hawkins; Phone Number: 347-963-8845; Email: dh3078@cumc.columbia.edu
• Study Contact Backup: Name: Joseariel Romero; Email: jr4119@cumc.columbia.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University Irving Medical Center
      • Contact: Marie-Pierre St-Onge, PhD; Email: ms2554@cumc.columbia.edu
      • Principal Investigator: Marie-Pierre St-Onge

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Self-reported sleep quality	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	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	Amount of 6-sulfatoxymelatonin present in urine collected overnight, reported as ng/mg creatinine (corrected for creatinine content).	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep efficiency	Percent of time in bed spent asleep from wrist actigraphy	4 weeks
Sleep depth	Time spent in deep sleep from home sleep test	4 weeks
Sleepiness	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	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

Outcome Measure	Measure Description	Time Frame
Gut microbial diversity	Shannon index of alpha-diversity	4 weeks
Polyphenols	Total amount of polyphenols present in urine collected overnight	4 weeks
Polyphenol subtypes	Amount of each polyphenol subtype detected in urine collected overnight	4 weeks

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: American Pistachio Growers
• Investigators: Principal Investigator: Marie-Pierre St-Onge, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: October 16, 2025
• First Submitted That Met QC Criteria: October 16, 2025
• First Posted (Actual): October 20, 2025

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Public Health; Environment and Public Health; Technology, Industry, and Agriculture; Accident Prevention; Accidents; Industry; Food Industry; Safety; Food Safety; Food Quality; Food Technology; Hazard Analysis and Critical Control Points
• Other Study ID 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