- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07444671
Impact of Time-restricted Eating on Sleep, Glucose and Insulin Sensitivity
March 2, 2026 updated by: Colorado State University
The purpose of this research study is to see how the timing of eating impacts participants sleep and how the body responds to sugar.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This research study is aimed to answer how the timing of eating impacts participants sleep and how the body responds to sugar.
Participants must be healthy and between the ages of 18-65 to join .
This research study will take 2 weeks of outpatient monitoring, and 2 different nights staying in the Sleep and Metabolism Lab.
There are some risks to participating in this study, like hunger, skin irritation, discomfort with blood draws, and uncomfortableness while being observed.
The investigators hope that this research will benefit the knowledge learned about circadian rhythms and metabolic disease and how the timing of eating affects these things.
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Colorado
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Fort Collins, Colorado, United States, 80523
- Sleep and Metabolism Laboratory
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Healthy adult men and women ages 18-65
- habitual sleep duration between 7-9.25 hours
- lived at altitude for at least 3 months.
Exclusion Criteria:
- Diagnosed acute or chronic physical or psychiatric disorders;
- diagnosed sleep disorders;
- not participating in another research study concurrently which could increase risks, such as those involving medication or blood sampling;
- shiftwork in the 6 months before the study; travel more then one time zone three weeks prior to the study;
- blood donation 30 days prior to the first study visit;
- illicit drug use, prescribed medication use (excluding over the counter products) 30 days prior to the study visit;
- everyday nicotine use;
- regular consumption of over 400mg caffeine per day in the past month; and consumption of over 14 alcoholic beverages a week, or more than 4 alcoholic beverages in a single day over the past month for men and consumption of over 7 alcoholic beverages a week, or more than 3 alcoholic beverages in a single day over the past month for women.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control
For the week between equipment pickup and the first overnight stay participants will maintain normal eating habits and eat across the day based on timing discussed with study staff.
During this time study staff will ask participants to record meals by taking pictures and texting them to the Lab.
|
Participants consume a normal eating schedule across the day.
|
|
Experimental: Time restricted eating
For the week between the first and second overnight stay participants will be scheduled to eat a normal food quantity, but in a shorter period of time based on timing discussed with study staff.
Typically, this will mean they will stop eating sometime in the afternoon and not eat again until breakfast the following day.
During this time study staff will ask participants to record your meals by taking pictures and texting them to the Lab.
|
For the week between the first and second overnight stay participants will be scheduled to eat a normal food quantity, but in a shorter period of time based on timing discussed with study staff.
Typically, this will mean they will stop eating sometime in the afternoon and not eat again until breakfast the following day.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
24 hour Continuous Glucose Monitoring (Average glucose)
Time Frame: 2 weeks
|
Participants will wear a continuous glucose monitor for 2 weeks.
Week 1 will be compared to week 2.
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2 weeks
|
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Oral glucose tolerance test (2 hour glucose)
Time Frame: 2 weeks
|
Participants will complete an oral glucose tolerance test on 2 occasions (end of week 1 and end of week 2)
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2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 7, 2018
Primary Completion (Actual)
May 25, 2021
Study Completion (Actual)
May 25, 2021
Study Registration Dates
First Submitted
February 26, 2026
First Submitted That Met QC Criteria
February 26, 2026
First Posted (Actual)
March 3, 2026
Study Record Updates
Last Update Posted (Actual)
March 4, 2026
Last Update Submitted That Met QC Criteria
March 2, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Protocol # 18-8249H
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
IPD will be shared upon reasonable request to the PI, Dr. Josiane Broussard
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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