Time Restricted EatingNCT07444671
Impact of Time-restricted Eating on Sleep, Glucose and Insulin Sensitivity
A study testing Time restricted eating in people with Time Restricted Eating, run by Colorado State University at 1 site in United States.
Trial summary
The purpose of this research study is to see how the timing of eating impacts participants sleep and how the body responds to sugar. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Time Restricted Eating
- What is being tested?
- Time restricted eating
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2018to 25 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult men and women ages 18-65
- habitual sleep duration between 7-9.25 hours
- lived at altitude for at least 3 months.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sleep and Metabolism Laboratory
Fort Collins, Colorado, 80523
About this study
The purpose of this research study is to see how the timing of eating impacts participants sleep and how the body responds to sugar.
Read the 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.
- Conditions
- Time Restricted Eating
- Being tested
- Time restricted eating, Control eating
- Medical subject headings
- Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time restricted eatingOther
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.
Control eatingOther
Participants consume a normal eating schedule across the day.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | 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. Receives: Other: Control eating |
| Time restricted eating | Experimental | 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. Receives: Other: Time restricted eating |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 hour Continuous Glucose Monitoring (Average glucose)
Participants will wear a continuous glucose monitor for 2 weeks. Week 1 will be compared to week 2.
Measured: 2 weeks
Oral glucose tolerance test (2 hour glucose)
Participants will complete an oral glucose tolerance test on 2 occasions (end of week 1 and end of week 2)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start7 Dec 2018
- Primary completion25 May 2021
- Study completion25 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Time Restricted EatingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07444671
- Sponsor's protocol ID
- Protocol # 18-8249H
- Status last verified
- Mar 2026
- First submitted
- 26 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be shared upon reasonable request to the PI, Dr. Josiane Broussard
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Time-restricted Eating on Sleep, Glucose and Insulin Sensitivity
- ClinicalTrials.gov ID
- NCT07444671
- Acronym / sponsor ID
- Protocol # 18-8249H
- Conditions
- Time Restricted Eating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Study start
- 7 Dec 2018 (actual)
- Primary completion
- 25 May 2021 (actual)
- Study completion
- 25 May 2021 (actual)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to see how the timing of eating impacts participants sleep and how the body responds to sugar.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Control eatingFor 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. |
| Time restricted eating | Experimental | Other: Time restricted eatingFor 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy adult men and women ages 18-65
- habitual sleep duration between 7-9.25 hours
- lived at altitude for at least 3 months.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time restricted eatingFor 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. | Other | Time restricted eating |
| Control eatingParticipants consume a normal eating schedule across the day. | Other | Control |
Primary outcome
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.
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: No. IPD will be shared upon reasonable request to the PI, Dr. Josiane Broussard
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time restricted eating in people with Time Restricted Eating, run by Colorado State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24 hour Continuous Glucose Monitoring (Average glucose) (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.