Impact of Pistachio Consumption on Sleep.

Not Applicable

Recruiting

• Conditions: Poor Quality Sleep

• Registration Number: NCT07218822
• Lead Sponsor: Columbia University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-16
• Study First Submitted QC: 2025-10-16
• Last Update Submitted: 2025-10-16
• Study First Posted: 2025-10-20
• Last Update Posted: 2025-10-20
• Study Start: 2025-10-31
• Primary Completion: 2027-08-31
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 28

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Self-reported sleep quality	4 weeks	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.
Objective sleep quality	4 weeks	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.
Overnight melatonin production	4 weeks	Amount of 6-sulfatoxymelatonin present in urine collected overnight, reported as ng/mg creatinine (corrected for creatinine content).

Secondary Outcome Measures

Name	Time	Method
Insomnia symptoms	4 weeks	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.
Sleep efficiency	4 weeks	Percent of time in bed spent asleep from wrist actigraphy
Sleep depth	4 weeks	Time spent in deep sleep from home sleep test
Sleepiness	4 weeks	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.

Trial Locations

Locations (1)

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States