RECRUITING

Mechanistic Effect of Walnut Consumption on Sleep Quality

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Mechanistic Effect of Walnut Consumption on Sleep Quality

Quick Facts

Study Start:2024-06-28
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06430086

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Equal numbers of men and women (12 male and 12 post-menopausal female)
  2. * Equal number of individuals with normal weight (18.5-24.9 kg/m2) and overweight (25-29.9 kg/m2)
  3. * Participants will self-report poor sleep quality, reflected by a global score \>5 on Pittsburgh Sleep Quality Index
  1. * Diagnosed sleep disorder
  2. * Participants with conditions that could affect sleep will be excluded:
  3. * smoking, excessive caffeine intake (\>300 mg/day)
  4. * shift work
  5. * chronic pain
  6. * diagnosis of a chronic disease (e.g., uncontrolled hypertension, pre-diabetes, type 2 diabetes, chronic kidney disease, chronic obstructive pulmonary disease),
  7. * autoimmune diseases
  8. * cardiovascular event or cancer in the past 24 months
  9. * psychiatric/neurologic disease or disorder, or sleep disorder (diagnosed or high risk for sleep apnea, chronic insomnia, restless leg syndrome, narcolepsy)
  10. * use of medications that influence CYP1A2 enzymes
  11. * Allergy/intolerance to nuts, tree nuts, or unwilling to eat study foods

Contacts and Locations

Study Contact

Lena Navarro, BS
CONTACT
347-963-8845
lrn2116@cumc.columbia.edu
Claudia Dreyer, BS
CONTACT
347-881-6008
cd3003@cumc.columbia.edu

Principal Investigator

Marie-Pierre St-Onge, PhD
PRINCIPAL_INVESTIGATOR
Associate Professor of Nutritional Medicine

Study Locations (Sites)

Columbia University Irving Medical Center
New York, New York, 10032
United States

Collaborators and Investigators

Sponsor: Columbia University

  • Marie-Pierre St-Onge, PhD, PRINCIPAL_INVESTIGATOR, Associate Professor of Nutritional Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-28
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2024-06-28
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Poor Sleep Quality