NCT06430086 Mechanistic Effect of Walnut Consumption on Sleep Quality
| NCT ID | NCT06430086 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Columbia University |
| Condition | Poor Sleep Quality |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2024-06-28 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2024-06-28 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Poor sleep quality is very common in modern society. Walnuts contain many nutrients that may be helpful for sleep, including melatonin and polyphenols. Some studies show that eating foods high in melatonin and polyphenols improves sleep quality, but walnuts have not been studied specifically. This study proposes to test if eating walnuts improves sleep compared to a food that lacks these sleep-promoting factors. The investigators expect that walnut consumption for 4 days will increase melatonin levels and lead to better sleep quality compared to a high-carbohydrate, high-sugar food. The study will enroll middle-aged and older adults with sleep complaints to participate in this study. Each person will eat the two different foods for 4 days each in random order. The 4-day periods will be separated by at least 2-3 weeks. Sleep quality will be measured by questionnaire and with a wrist monitor every day. The investigators will also do a sleep study using electroencephalography (EEG) on night 3 and take measures of circadian physiology (natural body rhythms) in the laboratory on day 4 (including overnight) by measuring body temperature and blood and urine melatonin. The study findings may provide new options to improve sleep health from increased walnut consumption.
Eligibility Criteria
Inclusion Criteria: * Equal numbers of men and women (12 male and 12 post-menopausal female) * Equal number of individuals with normal weight (18.5-24.9 kg/m2) and overweight (25-29.9 kg/m2) * Participants will self-report poor sleep quality, reflected by a global score \>5 on Pittsburgh Sleep Quality Index Exclusion Criteria: * Diagnosed sleep disorder * Participants with conditions that could affect sleep will be excluded: * smoking, excessive caffeine intake (\>300 mg/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) * use of medications that influence CYP1A2 enzymes * Allergy/intolerance to nuts, tree nuts, or unwilling to eat study foods
Contact & Investigator
Marie-Pierre St-Onge, PhD
PRINCIPAL INVESTIGATOR
Associate Professor of Nutritional Medicine
Frequently Asked Questions
Who can join the NCT06430086 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 65 Years, studying Poor Sleep Quality. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06430086 currently recruiting?
Yes, NCT06430086 is actively recruiting participants. Contact the research team at jr4119@cumc.columbia.edu for enrollment information.
Where is the NCT06430086 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06430086 clinical trial?
NCT06430086 is sponsored by Columbia University. The principal investigator is Marie-Pierre St-Onge, PhD at Associate Professor of Nutritional Medicine. The trial plans to enroll 24 participants.