Impact of Pistachio Consumption on Sleep

Overview

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.

Interventions

• Dietary supplement Pistachio
  2 servings/day for 4 weeks (56 g total/day)
• Dietary supplement Control food
  Muffins and cookies (no nuts), at an equivalent number of calories as the pistachio intervention, daily

Primary outcome measures

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

Secondary outcome measures (4)

• Sleep efficiency [Time frame: 4 weeks]
• Sleep depth [Time frame: 4 weeks]
• Sleepiness [Time frame: 4 weeks]
• Insomnia symptoms [Time frame: 4 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Columbia University Irving Medical Center — New York

Identifiers

NCT: NCT07218822 · AAAV9510

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗