Clinical trial for Poor Sleep Quality
Official title Mechanistic Effect of Walnut Consumption on Sleep Quality
ClinicalTrials.gov ID: NCT06430086
What this study is testing
- What it's testing
- The study aims to see if a short period of walnut consumption raises melatonin levels and improves sleep quality more than a high‑carbohydrate, high‑sugar food.
- Who it's for
- Middle‑aged or older adults who report poor sleep quality.
- What's involved
- Participants will eat walnuts for 4 days and a control snack for 4 days in random order, with a 2‑3‑week break between periods. Each day they will complete a sleep questionnaire, wear a wrist‑monitor, and on day 3 they will have an overnight EEG sleep study. On day 4 they will have body‑temperature, blood and urine tests for melatonin.
- Time commitment
- About 8 days of eating the study foods plus several clinic visits for monitoring, with a 2‑3‑week washout between the two 4‑day periods.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 65. Healthy volunteers may be eligible.
You may be able to join 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 likely can't join if
- Diagnosed sleep disorder
- 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...
- autoimmune diseases
See the full eligibility 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
- Diagnosed sleep disorder
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at New York, New York, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.