Skip to content

Mechanistic Effect of Walnut Consumption on Sleep Quality

Mechanistic Effect of Walnut Consumption on Sleep Quality

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06430086
Enrollment
24
Registered
2024-05-28
Start date
2024-06-28
Completion date
2026-12-31
Last updated
2026-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Poor Sleep Quality

Keywords

Randomized crossover study, Controlled feeding, Dietary intervention, Inpatient visit, Outpatient monitoring

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.

Detailed description

Walnuts are a nutrient-rich food which provides melatonin and polyphenols. While there is evidence that dietary intakes of foods high in melatonin and polyphenols positively influence sleep quality, the effect of walnuts has not been investigated. The investigators propose to fill this knowledge gap by testing the effects of walnut consumption on serum melatonin and resulting sleep and circadian biology. The study hypotheses are that walnut consumption for 4 days will increase melatonin levels, suggestive of more robust circadian rhythms, and lead to better sleep quality compared to a high-carbohydrate high-sugar (HCHS) equivalent. Using a randomized controlled crossover trial, the study aims to: 1) determine the effect of walnut vs HCHS consumption on melatonin levels; and 2) determine the effect of walnut vs HCHS consumption on sleep and circadian physiology. Adult males and females with poor sleep quality will consume three servings/day of walnuts or an equicaloric HCHS food for 4 days. Sleep quality will be measured nightly using the Karolinska Sleep Diary and wrist actigraphy; sleep architecture from polysomnography will be measured on night 3. Circadian physiology will be assessed on day 4 using body temperature and hourly serum melatonin and on the morning of day 5 from overnight urinary 6-sulfatoxymelatonin. Given the extent of poor sleep, our findings may open new avenues to improve sleep health from increased walnut consumption.

Interventions

Participants will add one serving (1 oz) of walnuts at their self-defined breakfast, lunch, and dinner for 4 days. The study will provide study foods at 3 main meals each day to evaluate a temporal effect of the food on melatonin concentrations throughout the day.

OTHERHCHS consumption

Participants will add one HCHS food (one PopTarts® pastry) to each of their 3 main meals of the day for 4 days. The study will provide study foods at 3 main meals each day to evaluate a temporal effect of the food on melatonin concentrations throughout the day. An energy-matched high-carbohydrate, high-sugar (HCHS) alternative, representative of a common US snack food, on sleep quality in adults with habitually poor sleep quality.

Sponsors

Columbia University
Lead SponsorOTHER
United States Department of Agriculture (USDA)
CollaboratorFED
California Walnut Commission
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Masking description

Statistician will be masked to study condition. Participants cannot be masked. Other personnel involved in the study cannot be masked.

Intervention model description

Randomized crossover design

Eligibility

Sex/Gender
ALL
Age
45 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Serum melatoninBaseline (9AM; Hour 0), Hour 1, Hour 2, Hour 3, Hour 4, Hour 5, Hour 6, Hour 7, Hour 8, Hour 9, Hour 10, Hour 11, Hour 12, Hour 13, Hour 14, Hour 15 (Midnight)Serum melatonin will be measured via last testing of blood samples collected on day 4, in an inpatient setting. Repeated for each phase.
Sleep quality indexNight 1, Night 2, Night 3, Night 4Sleep quality will be assessed daily using wrist actigraphy. Variables include sleep fragmentation index and sleep efficiency. Repeated for each phase.
Slow wave sleep indexNight 3Slow wave sleep will be measured using electroencephalography, in the participant's home. Repeated for each phase.

Secondary

MeasureTime frameDescription
6-sulfatoxymelatonin levelNight 4 to morning of Day 5 (Approximately up to 12 hours)This is to measure Melatonin production in urine samples. Repeated for each phase.
Body temperatureDay 4Proximal to distal body temperature gradient measured using thermochron devices (iButtons). Repeated for each phase. In patient. Over 24 hours.
Sleep quality scoreDays 2, 3, 4, 5Self-reported sleep quality assessed using the Karolinska Sleep Diary (higher score represents better sleep). Repeated for each phase.

Countries

United States

Contacts

CONTACTJoseariel Romero
jr4119@cumc.columbia.edu347-963-8845
PRINCIPAL_INVESTIGATORMarie-Pierre St-Onge, PhD

Associate Professor of Nutritional Medicine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 1, 2026