Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06430086
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-05-21
Brief Title:
Mechanistic Effect of Walnut Consumption on Sleep Quality
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
Mechanistic Effect of Walnut Consumption on Sleep Quality
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 servingsday 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GRANT13949102 | OTHER_GRANT | USDANIFA | None |