Impact of Pistachio Consumption on Sleep

NCT ID: NCT07218822

Last Updated: 2026-02-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-12
• Study Completion Date: 2027-08-31

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Pistachio

Intervention Type: DIETARY_SUPPLEMENT

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

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.

Group Type: PLACEBO_COMPARATOR

Control food

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Pistachio

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

Intervention Type: DIETARY_SUPPLEMENT

Control food

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American Pistachio Growers

OTHER

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Marie-Pierre St-Onge

Professor of Nutritional Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marie-Pierre St-Onge

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Irving Medical Center

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Diane Hawkins

Role: CONTACT

dh3078@cumc.columbia.edu

347-963-8845

Joseariel Romero

Role: CONTACT

jr4119@cumc.columbia.edu

Facility Contacts

Marie-Pierre St-Onge, PhD

Role: primary

ms2554@cumc.columbia.edu

Other Identifiers

AAAV9510

Identifier Type: -

Identifier Source: org_study_id