Actively Recruiting

Phase Not Applicable
Age: 45Years - 65Years
All Genders
Healthy Volunteers
NCT06430086

Mechanistic Effect of Walnut Consumption on Sleep Quality

Led by Columbia University · Updated on 2025-07-31

24

Participants Needed

1

Research Sites

130 weeks

Total Duration

On this page

Sponsors

C

Columbia University

Lead Sponsor

U

United States Department of Agriculture (USDA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Mechanistic Effect of Walnut Consumption on Sleep Quality

Who Can Participate

Age: 45Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Equal numbers of men and post-menopausal women (12 males and 12 females)
  • Equal numbers of individuals with normal weight (BMI 18.5-24.9) and overweight (BMI 25-29.9)
  • Participants must self-report poor sleep quality with a Pittsburgh Sleep Quality Index score greater than 5
Not Eligible

You will not qualify if you...

  • Diagnosed sleep disorder
  • Smoking or excessive caffeine intake (over 300 mg/day)
  • Shift work
  • Chronic pain
  • Diagnosis of chronic diseases such as uncontrolled hypertension, pre-diabetes, type 2 diabetes, chronic kidney disease, chronic obstructive pulmonary disease
  • Autoimmune diseases
  • Cardiovascular event or cancer within the past 24 months
  • Psychiatric or neurologic disease or disorder
  • High risk or diagnosis of sleep apnea, chronic insomnia, restless leg syndrome, or narcolepsy
  • Use of medications that affect CYP1A2 enzymes
  • Allergy or intolerance to nuts or unwillingness to eat study foods

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Columbia University Irving Medical Center

New York, New York, United States, 10032

Actively Recruiting

Loading map...

Research Team

J

Joseariel Romero

CONTACT

C

Claudia Dreyer, BS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here