Impact of Pistachio Consumption on Sleep

NCT07218822 | Recruiting

• 1 other identifier: AAAV9510
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Sleep efficiency

  4 weeks

• Sleep depth

  4 weeks

• Sleepiness

  4 weeks

• Insomnia symptoms

  4 weeks

Other Outcomes (3)

• Gut microbial diversity

  4 weeks

• Polyphenols

  4 weeks

• Polyphenol subtypes

  4 weeks

Study Arms (2)

Pistachio

ACTIVE COMPARATOR

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

Control

PLACEBO COMPARATOR

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

Interventions

Pistachio DIETARY_SUPPLEMENT

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

Pistachio

Control food DIETARY_SUPPLEMENT

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

Control

Eligibility Criteria

• Age: 45 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• American Pistachio Growers: collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

MeSH Terms

Interventions

Hazard Analysis and Critical Control Points

Intervention Hierarchy (Ancestors)

Food Safety; Food Quality; Food Technology; Food Industry; Industry; Technology, Industry, and Agriculture; Safety; Accident Prevention; Accidents; Public Health; Environment and Public Health

Study Officials

• Marie-Pierre St-Onge

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diane Hawkins

CONTACT

347-963-8845; dh3078@cumc.columbia.edu

Joseariel Romero

CONTACT

jr4119@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Nutritional Medicine

Model Details: Randomized, placebo-controlled, dietary intervention with two intervention periods of 4 weeks each, separated by 2-4 week washout period.

Study Record Dates

• First Submitted: October 16, 2025
• First Posted: October 20, 2025
• Study Start: December 12, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

US (1)