Mechanistic Effect of Walnut Consumption on Sleep Quality

NCT06430086 | Recruiting

• 2 other identifiers: AAAV1362GRANT13949102
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Poor Sleep Quality

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Serum melatonin

  Serum melatonin will be measured via last testing of blood samples collected on day 4, in an inpatient setting. Repeated for each phase.

  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)

• Sleep quality index

  Sleep quality will be assessed daily using wrist actigraphy. Variables include sleep fragmentation index and sleep efficiency. Repeated for each phase.

  Night 1, Night 2, Night 3, Night 4

• Slow wave sleep index

  Slow wave sleep will be measured using electroencephalography, in the participant's home. Repeated for each phase.

  Night 3

Secondary Outcomes (3)

• 6-sulfatoxymelatonin level

  Night 4 to morning of Day 5 (Approximately up to 12 hours)

• Body temperature

  Day 4

• Sleep quality score

  Days 2, 3, 4, 5

Other Outcomes (1)

• NFkB level

  Day 4 (or Day 5)

Study Arms (2)

Walnut - washout - HCHS

EXPERIMENTAL

Participants will consume 3 servings/day of walnuts (3 oz/d) over 4 days and have a washout for 2-3 weeks then crossover to consume 3 equicaloric servings of a HCHS food over 4 days. Over each 4-day period, participants will sleep and eat at home for the first 3 days and will be admitted to the Inpatient Clinical Research Resource of the Irving Institute for Clinical and Translational Research of CUIMC on day 4 for in-depth profiling circadian physiology. Participants will be discharged on the morning of day 5.

Other: Walnut consumption; Other: HCHS consumption

HCHS - washout - Walnut

EXPERIMENTAL

Participants will consume 3 equicaloric servings of a HCHS food over 4 days and have a washout for 2-3 weeks then crossover to consume 3 servings/day of walnuts (3 oz/d) for 4 days. Over each 4-day period, participants will sleep and eat at home for the first 3 days and will be admitted to the Inpatient Clinical Research Resource of the Irving Institute for Clinical and Translational Research of CUIMC on day 4 for in-depth profiling circadian physiology. Participants will be discharged on the morning of day 5.

Other: Walnut consumption; Other: HCHS consumption

Interventions

Walnut consumption OTHER

Participants will add one serving (1 oz) of walnuts at their self-defined breakfast, lunch, and dinner for 4 days. The study will provide study foods at 3 main meals each day to evaluate a temporal effect of the food on melatonin concentrations throughout the day.

HCHS - washout - Walnut; Walnut - washout - HCHS

HCHS consumption OTHER

Participants will add one HCHS food (one PopTarts® pastry) to each of their 3 main meals of the day for 4 days. The study will provide study foods at 3 main meals each day to evaluate a temporal effect of the food on melatonin concentrations throughout the day. An energy-matched high-carbohydrate, high-sugar (HCHS) alternative, representative of a common US snack food, on sleep quality in adults with habitually poor sleep quality.

HCHS - washout - Walnut; Walnut - washout - HCHS

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• United States Department of Agriculture (USDA): collaborator
• California Walnut Commission: collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

Study Officials

• Marie-Pierre St-Onge, PhD

  Associate Professor of Nutritional Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseariel Romero

CONTACT

347-963-8845; jr4119@cumc.columbia.edu

Claudia Dreyer, BS

CONTACT

347-881-6008; cd3003@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Statistician will be masked to study condition. Participants cannot be masked. Other personnel involved in the study cannot be masked.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Nutritional Medicine

Model Details: Randomized crossover design

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: May 28, 2024
• Study Start: June 28, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Within 12 months of final study completion.

Locations

US (1)