Impact of Pistachio Consumption on Sleep

Columbia University

Status: Enrolling

Conditions: Poor Quality Sleep

Treatments: Dietary Supplement: Pistachio; Dietary Supplement: Control food

Study type: Interventional

Funder types: Other

Identifiers

NCT07218822

AAAV9510

Details and patient eligibility

About

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.

Enrollment: 28 estimated patients

Sex: All

Ages: 45 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 2 patient groups, including a placebo group

Pistachio

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Pistachio

Control

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Control food