Impact of Pistachio Consumption on Sleep
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Columbia University
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Self-reported sleep quality
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 45 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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:
- •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
Arms & Interventions
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.
Intervention: Pistachio (Dietary Supplement)
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.
Intervention: Control food (Dietary Supplement)
Outcomes
Primary Outcomes
Self-reported sleep quality
Time Frame: 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
Time Frame: 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
Time Frame: 4 weeks
Amount of 6-sulfatoxymelatonin present in urine collected overnight, reported as ng/mg creatinine (corrected for creatinine content).
Secondary Outcomes
- Insomnia symptoms(4 weeks)
- Sleep efficiency(4 weeks)
- Sleep depth(4 weeks)
- Sleepiness(4 weeks)
Investigators
Marie-Pierre St-Onge
Professor of Nutritional Medicine
Columbia University