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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

No Placebo-Only Group

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

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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a diagnosed sleep or eating disorder.

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I have been diagnosed with diabetes or heart disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ collected during inpatient laboratory visit after 4 weeks of control and tre

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Blood pressure via 24-hour assessments

Insulin sensitivity via clamp

Secondary study objectives

Cerebrovascular reactivity via transcranial doppler

Muscle lipid accumulation via lipidomics

Other study objectives

24-hour blood sampling for lipids, glucose, insulin, and vascular markers

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~850

0 / 3Eligibility criteria met