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Light Exposure + Meal Timing for Circadian Rhythm Management (LipidPRC Trial)

N/A
Recruiting
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged between 18-30 years
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6.5 hours during intervention
Awards & highlights

LipidPRC Trial Summary

This trial is testing whether light or meal times have a bigger impact on the body's natural sleep cycle and metabolism.

Who is the study for?
This trial is for healthy individuals aged 18-30 who don't smoke, use drugs, or have sleep disorders. They must maintain an 8-hour sleep schedule and avoid caffeine, alcohol, and most medications during the study. Participants should have a BMI between >18 and <30 kg/m2.Check my eligibility
What is being tested?
The study tests whether light exposure or meal timing has a greater effect on resetting circadian rhythms related to melatonin production and metabolism. It involves time-restricted eating within a 12-hour window and exposure to bright or dim light.See study design
What are the potential side effects?
Potential side effects may include changes in sleep patterns, mood variations due to altered circadian rhythms, eye strain from different lighting conditions, and hunger or digestive discomfort from the restricted eating schedule.

LipidPRC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 30 years old.

LipidPRC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6.5 hours during intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6.5 hours during intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Amplitude of Phase Response Curve of cholesterol
Amplitude of Phase Response Curve of melatonin
Amplitude of Phase Response Curve of triglyceride
Secondary outcome measures
Area under the curve (AUC) of cholesterol
Area under the curve (AUC) of melatonin
Area under the curve (AUC) of triglyceride

LipidPRC Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Time-restricted eatingExperimental Treatment2 Interventions
Participants will consume 4 identical meals, as in the other groups, except that the meal window will be restricted to 6.5 hours instead of 12 hours (meals at 4.75, 6.9, 9.1, 11.25 hours after waking) centered within the 16-hour wake episode. Participants will remain in dim light (<3 lux) throughout the 16-hour wake episode.
Group II: Bright lightExperimental Treatment2 Interventions
Participants will receive a 6.5-hour 10,000 lux light pulse (4100K fluorescent light) centered within the 16-hour wake episode (start 4.75 hour after wake and end 11.25 hour after wake). Participants will receive 4 identical meals (equal calories and macronutrient content), over a 12-hour interval (meals at 2, 6, 10, and 14 hours after waking) centered within the 16-hour wake episode.
Group III: ControlPlacebo Group2 Interventions
Participants will receive 4 identical meals (equal calories and macronutrient content), over a 12-hour interval (meals at 2, 6, 10, and 14 hours after waking) centered within the 16-hour wake episode. Participants will remain in dim light (<3 lux) throughout the 16-hour wake episode.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Time-restricted eating
2022
N/A
~520
Bright Light
2013
N/A
~120

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,602 Previous Clinical Trials
11,463,177 Total Patients Enrolled

Media Library

Time-restricted eating Clinical Trial Eligibility Overview. Trial Name: NCT05276739 — N/A
Photophobia Research Study Groups: Bright light, Time-restricted eating, Control
Photophobia Clinical Trial 2023: Time-restricted eating Highlights & Side Effects. Trial Name: NCT05276739 — N/A
Time-restricted eating 2023 Treatment Timeline for Medical Study. Trial Name: NCT05276739 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment for this clinical trial currently taking place?

"Affirmative, according to clinicaltrials.gov the trial is still seeking participants who were first invited on August 1st 2022 and most recently updated on July 11th 2022. 48 patients are needed from a single medical centre for this study."

Answered by AI

How many people have been enrolled in the research project thus far?

"Affirmative, the clinicaltrials.gov entry indicates that this study is presently seeking participants. It was initially published on August 1st 2022 and updated most recently on July 11th 2022. The trial needs 48 patients from one site in order to be completed."

Answered by AI

Does this research program accept participants of fifty-one years or older?

"Qualified participants for this medical trial are expected to be within the 18-30 age range."

Answered by AI

Who is qualified to take part in this research initiative?

"Eligible candidates for this trial must be exposed to light and between the age of 18 and 30. Approximately 48 people are needed to complete recruitment."

Answered by AI
~18 spots leftby Mar 2025