NCT07218822 Impact of Pistachio Consumption on Sleep
| NCT ID | NCT07218822 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Columbia University |
| Condition | Poor Quality Sleep |
| Study Type | INTERVENTIONAL |
| Enrollment | 28 participants |
| Start Date | 2025-12-12 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 28 participants in total. It began in 2025-12-12 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Marie-Pierre St-Onge
PRINCIPAL INVESTIGATOR
Columbia University
Frequently Asked Questions
Who can join the NCT07218822 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 64 Years, studying Poor Quality Sleep. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07218822 currently recruiting?
Yes, NCT07218822 is actively recruiting participants. Contact the research team at dh3078@cumc.columbia.edu for enrollment information.
Where is the NCT07218822 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT07218822 clinical trial?
NCT07218822 is sponsored by Columbia University. The principal investigator is Marie-Pierre St-Onge at Columbia University. The trial plans to enroll 28 participants.