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| Name | Class |
|---|---|
| American Pistachio Growers | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pistachio | Active Comparator | 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. |
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| Control | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pistachio | Dietary Supplement | 2 servings/day for 4 weeks (56 g total/day) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported sleep quality | 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. | 4 weeks |
| Objective sleep quality | 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. | 4 weeks |
| Overnight melatonin production | Amount of 6-sulfatoxymelatonin present in urine collected overnight, reported as ng/mg creatinine (corrected for creatinine content). | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep efficiency | Percent of time in bed spent asleep from wrist actigraphy | 4 weeks |
| Sleep depth | Time spent in deep sleep from home sleep test |
| Measure | Description | Time Frame |
|---|---|---|
| Gut microbial diversity | Shannon index of alpha-diversity | 4 weeks |
| Polyphenols | Total amount of polyphenols present in urine collected overnight |
Inclusion Criteria:
Exclusion Criteria:
Premenopausal women
Medical or living conditions that could affect sleep:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Diane Hawkins | Contact | 347-963-8845 | dh3078@cumc.columbia.edu | |
| Joseariel Romero | Contact | jr4119@cumc.columbia.edu |
| Name | Affiliation | Role |
|---|---|---|
| Marie-Pierre St-Onge | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Irving Medical Center | Recruiting | New York | New York | 10032 | United States |
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| ID | Term |
|---|---|
| D064088 | Hazard Analysis and Critical Control Points |
| ID | Term |
|---|---|
| D059022 | Food Safety |
| D063427 | Food Quality |
| D005524 | Food Technology |
| D019649 | Food Industry |
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Randomized, placebo-controlled, dietary intervention with two intervention periods of 4 weeks each, separated by 2-4 week washout period.
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| Control food |
| Dietary Supplement |
Muffins and cookies (no nuts), at an equivalent number of calories as the pistachio intervention, daily |
|
| 4 weeks |
| Sleepiness | 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. | 4 weeks |
| Insomnia symptoms | 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. | 4 weeks |
| 4 weeks |
| Polyphenol subtypes | Amount of each polyphenol subtype detected in urine collected overnight | 4 weeks |
| D007221 |
| Industry |
| D013676 | Technology, Industry, and Agriculture |
| D012449 | Safety |
| D000056 | Accident Prevention |
| D000059 | Accidents |
| D011634 | Public Health |
| D004778 | Environment and Public Health |