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Search / Trial NCT06430086

Mechanistic Effect of Walnut Consumption on Sleep Quality

Launched by COLUMBIA UNIVERSITY · May 21, 2024

Trial Information

Current as of July 01, 2025

Recruiting

Keywords

Randomized Crossover Study Controlled Feeding Dietary Intervention Inpatient Visit Outpatient Monitoring

ClinConnect Summary

This clinical trial is studying whether eating walnuts can improve sleep quality in people who have trouble sleeping. Walnuts are thought to have nutrients that might help, such as melatonin, which is a natural hormone that helps regulate sleep. In this study, participants will eat walnuts for four days and then a different food that is high in carbohydrates and sugar for another four days. Researchers will measure sleep quality using questionnaires and a wrist monitor, and they will conduct a sleep study to gather more detailed information about sleep patterns.

To participate, you must be a middle-aged or older adult who often struggles with sleep, scoring above 5 on a sleep quality scale. The study is looking for equal numbers of men and women, as well as individuals with normal weight and those who are overweight. However, those with diagnosed sleep disorders or certain health conditions, like chronic pain or recent serious illnesses, won’t be eligible. If you join, you can expect to contribute to important research that may offer new ways to improve sleep by simply adding walnuts to your diet!

Gender

ALL

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

About Columbia University

Columbia University, a prestigious Ivy League institution located in New York City, is a leading sponsor of clinical trials dedicated to advancing medical research and improving patient care. With a robust network of research facilities and a commitment to innovation, Columbia University collaborates with a diverse range of healthcare professionals and researchers to explore groundbreaking therapies and treatment methodologies. The university's clinical trials encompass various fields, including oncology, neurology, and public health, aiming to translate scientific discoveries into effective clinical applications. Columbia University is dedicated to maintaining the highest ethical standards and regulatory compliance, ensuring the safety and well-being of trial participants while contributing to the global body of medical knowledge.

Locations

New York, New York, United States

Patients applied

0 patients applied

Trial Officials

Marie-Pierre St-Onge, PhD

Principal Investigator

Associate Professor of Nutritional Medicine

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported