Clinical trial NCT06430086: Mechanistic Effect of Walnut Consumption on Sleep Quality
Official title: Mechanistic Effect of Walnut Consumption on Sleep Quality
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Poor Sleep Quality
Keywords: Randomized crossover study
Controlled feeding
Dietary intervention
Inpatient visit
Outpatient monitoring
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: United States Department of Agriculture (USDA)
name: California Walnut Commission
First posted: 2024-05-28
Enrollment: 24
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized crossover design
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Serum melatonin
timeFrame: Baseline (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)
measure: Sleep quality index
timeFrame: Night 1, Night 2, Night 3, Night 4
measure: Slow wave sleep index
timeFrame: Night 3
Secondary outcomes:
measure: 6-sulfatoxymelatonin level
timeFrame: Night 4 to morning of Day 5 (Approximately up to 12 hours)
measure: Body temperature
timeFrame: Day 4
measure: Sleep quality score
timeFrame: Days 2, 3, 4, 5
Other outcomes:
measure: NFkB level
timeFrame: Day 4 (or Day 5)
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Associate Professor of Nutritional Medicine
name: Marie-Pierre St-Onge, PhD
role: PRINCIPAL_INVESTIGATOR
References: