Recruiting

Pistachio Consumption

Sponsor:

Columbia University

Code:

NCT07218822

Conditions

Poor Quality Sleep

Eligibility Criteria

Sex: All

Age: 45 - 64

Healthy Volunteers: Accepted

Interventions

Pistachio

Control food

Study Details

Brief summary:

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.

Conditions

Poor Quality Sleep

Study ID

NCT07218822

Start date

Dec 12, 2025

Status verified date

Feb, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 64

Healthy Volunteers: Accepted

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 Design

Enrollment

28 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Pistachio

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

Control food

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

Primary outcome measure

  • Self-reported sleep quality [ Time Frame: 4 weeks ]
  • Objective sleep quality [ Time Frame: 4 weeks ]
  • Overnight melatonin production [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Locations

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Marie-Pierre St-Onge, PhD

ms2554@cumc.columbia.edu

Principal Investigator:

Marie-Pierre St-Onge

More Information

Sponsor

Columbia University

Last update posted

Feb 13, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2026-02-13.