← Back to Search

Behavioral Intervention

Time-Restricted Eating for Shift Work Sleep Disorder (SHINE Trial)

N/A
Recruiting
Led By Josiane L Broussard, PhD
Research Sponsored by Colorado State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18-65 years old
Be older than 18 years old
Must not have
Existing diagnosed sleep or eating disorder (e.g. obstructive sleep apnea [OSA], periodic limb movements of sleep [PLMS], narcolepsy, travel more than 1 time zone in 3 weeks before the study; anorexia nervosa, more than one food allergy to maintain flexibility in diet planning)
Diagnosed diabetes or cardiovascular disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up collected during inpatient laboratory visit after 4 weeks of control and tre
Awards & highlights

Summary

This trial aims to understand how working irregular hours, like shift workers, increases the risk of heart disease and Type 2 diabetes. The study will investigate if high levels of fats in the blood play a

Who is the study for?
This trial is for chronic night shift workers who may have sleep and circadian rhythm disorders, insulin sensitivity or resistance issues, metabolic diseases, high blood pressure but not severe allergies.
What is being tested?
The study investigates if eating within a set time frame (time-restricted eating) versus regular eating patterns (control eating) affects heart health and sugar metabolism in people with disrupted body clocks due to shift work.
What are the potential side effects?
Since the interventions involve dietary changes rather than medication, side effects might include hunger at unusual times or discomfort adjusting to new meal schedules.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a diagnosed sleep or eating disorder.
Select...
I have been diagnosed with diabetes or heart disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~collected during inpatient laboratory visit after 4 weeks of control and tre
This trial's timeline: 3 weeks for screening, Varies for treatment, and collected during inpatient laboratory visit after 4 weeks of control and tre for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Blood pressure via 24-hour assessments
Insulin sensitivity via clamp
Secondary outcome measures
Cerebrovascular reactivity via transcranial doppler
Muscle lipid accumulation via lipidomics
Other outcome measures
24-hour blood sampling for lipids, glucose, insulin, and vascular markers

Trial Design

2Treatment groups
Experimental Treatment
Group I: Time-restricted eating during overnight work shiftExperimental Treatment1 Intervention
For 4 weeks, participants will refrain from eating during the biological night while maintaining the same sleep opportunity and daily energy intake and macronutrient distribution without changing 24h energy intake.
Group II: Control eating during overnight work shiftExperimental Treatment1 Intervention
For 4 weeks, participants will eat during the biological night as is typically done in night shift workers.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Time-restricted eating
2022
N/A
~800

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,889 Previous Clinical Trials
47,834,157 Total Patients Enrolled
4 Trials studying Insulin Sensitivity
280 Patients Enrolled for Insulin Sensitivity
Colorado State UniversityLead Sponsor
131 Previous Clinical Trials
38,168 Total Patients Enrolled
3 Trials studying Insulin Sensitivity
269 Patients Enrolled for Insulin Sensitivity
University of Colorado, DenverOTHER
1,786 Previous Clinical Trials
2,787,558 Total Patients Enrolled
9 Trials studying Insulin Sensitivity
638 Patients Enrolled for Insulin Sensitivity
~33 spots leftby Jun 2028
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top