Poor Quality SleepNCT07218822
Impact of Pistachio Consumption on Sleep
A study testing Pistachio in people with Poor Quality Sleep, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Poor Quality Sleep
- What is being tested?
- Pistachio
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2025to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Premenopausal women
- Medical or living conditions that could affect sleep:
- Smoking
- Excessive caffeine intake (>300 mg/day)
- Non-day shift work
- Chronic pain
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Joseariel Romero contact
United States1 site, 1 recruiting
- Recruiting
Columbia University Irving Medical Center
New York, New York, 10032
Marie-Pierre St-Onge, PhD, ms2554@cumc.columbia.edu
Marie-Pierre St-Onge
About this study
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.
- Conditions
- Poor Quality Sleep
- Being tested
- Pistachio, Control food
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PistachioDietary supplement
2 servings/day for 4 weeks (56 g total/day)
Control foodDietary supplement
Muffins and cookies (no nuts), at an equivalent number of calories as the pistachio intervention, daily
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Pistachio |
| 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. Receives: Dietary Supplement: Control food |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 weeks
Overnight melatonin production
Amount of 6-sulfatoxymelatonin present in urine collected overnight, reported as ng/mg creatinine (corrected for creatinine content).
Measured: 4 weeks
Secondary outcomes (4)
Sleep efficiency
Percent of time in bed spent asleep from wrist actigraphy
Measured: 4 weeks
Sleep depth
Time spent in deep sleep from home sleep test
Measured: 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.
Measured: 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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2025
- Study start12 Dec 2025
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Poor Quality SleepStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, placebo-controlled, dietary intervention with two intervention periods of 4 weeks each, separated by 2-4 week washout period.
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- American Pistachio Growers
- Responsible party
- Principal investigator, Marie-Pierre St-Onge, Columbia University
- Investigators
- Marie-Pierre St-Onge, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07218822
- Sponsor's protocol ID
- AAAV9510
- Status last verified
- Feb 2026
- First submitted
- 16 Oct 2025
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pistachio Consumption on Sleep
- ClinicalTrials.gov ID
- NCT07218822
- Acronym / sponsor ID
- AAAV9510
- Conditions
- Poor Quality Sleep
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- American Pistachio Growers
- Study start
- 12 Dec 2025 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 20 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, placebo-controlled, dietary intervention with two intervention periods of 4 weeks each, separated by 2-4 week washout period.
| Arm | Type | Receives |
|---|---|---|
| Pistachio | Active comparator | Dietary Supplement: PistachioDuring 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. |
| Control | Placebo comparator | Dietary Supplement: Control foodDuring 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. |
Who may qualify
- Ages
- 45 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pistachio2 servings/day for 4 weeks (56 g total/day) | Dietary supplement | Pistachio |
| Control foodMuffins and cookies (no nuts), at an equivalent number of calories as the pistachio intervention, daily | Dietary supplement | Control |
Primary outcome
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).
4 secondary outcomes
Sleep efficiency
Time frame: 4 weeks
Sleep depth
Time frame: 4 weeks
Sleepiness
Time frame: 4 weeks
Insomnia symptoms
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joseariel Romero contact
Marie-Pierre St-Onge principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pistachio in people with Poor Quality Sleep, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diane Hawkins (347-963-8845, dh3078@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported sleep quality (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.