Impact of Pistachio Consumption on Sleep

ConditionPoor Quality Sleep

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age45-64

SponsorColumbia University

About this trial

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

This trial accepts healthy volunteers

Qualifiers

Poor sleep quality, Pittsburgh Sleep Quality Index score >5

BMI 20 - 29.9 kg/m²

Ability to abstain from travel across time zones

Willingness to eat study foods

Disqualifiers

Premenopausal women

Smoking

Excessive caffeine intake (>300 mg/day)

Non-day shift work

Trial design

Design model

Crossover

Treatments tested in this trial

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

Treatment groups

28 Participants

are divided into 2 treatment groups

Group A: PistachioActive comparator 1 intervention

Group B: ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

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.

Time frame

4 weeks

Overnight melatonin production

Amount of 6-sulfatoxymelatonin present in urine collected overnight, reported as ng/mg creatinine (corrected for creatinine content).

Time frame

4 weeks

Secondary outcomes

Sleep efficiency

Percent of time in bed spent asleep from wrist actigraphy

Time frame

4 weeks

Sleep depth

Time spent in deep sleep from home sleep test

Time frame

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.

Time frame

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.

Time frame

4 weeks

Other outcomes

Gut microbial diversity

Shannon index of alpha-diversity

Time frame

4 weeks

Polyphenols

Total amount of polyphenols present in urine collected overnight

Time frame

4 weeks

Polyphenol subtypes

Amount of each polyphenol subtype detected in urine collected overnight

Time frame

4 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Columbia University

Lead sponsor

American Pistachio Growers

Collaborator

Source ClinicalTrials.gov

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