Time Restricted EatingEarly Phase 1TERESANCT06047496
Time Restricted Eating in Sleep Apnea
A Early Phase 1 study testing Time restricted eating in people with Time Restricted Eating and Obstructive Sleep Apnea, run by University of California, San Diego at 1 site in United States.
Trial summary
Obstructive sleep apnea (OSA) is a highly prevalent disorder that is associated with both cardiovascular and metabolic dysfunction, such as hypertension, increased blood glucose levels and diabetes, obesity, and nonalcoholic fatty liver. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Time Restricted Eating, Obstructive Sleep Apnea
- What is being tested?
- Time restricted eating
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2024to Dec 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form;
- Stated willingness to comply with all study procedures and availability for the duration of the study;
- Be of appropriate age (18-70);
- Own a smartphone (Apple iOS or Android OS);
- Have a baseline eating period ≥12 hours/day and sufficient logging on the myCircadianClock app;
- If participants are on cardiovascular medications (HMG CoA reductase inhibitors (statins), other lipid-modifying drugs, anti-hypertensives) no dose adjustments will be allowed during the study period;
- Have untreated moderate to severe obstructive sleep apnea (OSA, apnea-hypopnea index ≥15 events/hr); and
- Agree to adhere to Lifestyle Considerations (see section 5.3) throughout study duration]
Who cannot join
- Participants with type 1 or type 2 diabetes mellitus who are taking insulin or sulfonylureas, or any participant with a history of hypoglycemia unawareness
- OSA with evidence of significant sleepiness, as defined by either a) Epworth Sleepiness Score ≥15, or b) motor vehicle accident due to excessive sleepiness within the past year
- BMI >40 kg/m2
- Uncontrolled hypertension
- Active tobacco or illicit drug use
- Pregnant or breastfeeding women
Show all 21Show fewer
- Currently enrolled in a weight-loss or weight-management program
- Currently on a special or prescribed diet for other reasons (e.g., Celiac disease)
- Currently taking any medication that is meant for weight loss, or has known effect on appetite suppression
- History of eating disorder(s)
- History of surgical intervention for weight management
- Chronic kidney disease
- Treatment for active inflammatory and/or rheumatologic disease and cancer
- Unrevascularized cardiovascular disease
- Liver cirrhosis and/or significant alterations in liver function
- History of (a) thyroid disease requiring dose titration of thyroid replacement medication(s) within the past 3 months (i.e., hypothyroidism on a stable dose of thyroid replacement therapy is not an exclusion)
- Shift workers with variable (e.g., occasionally nocturnal) hours
- Traveling outside the US
- History of HIV/AIDS
- Uncontrolled psychiatric disorder
- Other safety concern based on MD judgement
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California San Diego (ACTRI)
La Jolla, California, 92037
Omar Mesarwi, MD, 858-822-1783, omesarwi@health.ucsd.edu
About this study
Official title: The Time Restricted Eating in Sleep Apnea Study
Obstructive sleep apnea (OSA) is a highly prevalent disorder that is associated with both cardiovascular and metabolic dysfunction, such as hypertension, increased blood glucose levels and diabetes, obesity, and nonalcoholic fatty liver. While continuous positive airway pressure (CPAP), the best available OSA treatment, has been shown to improve blood pressure in OSA, it does not appear to improve metabolic consequences of OSA, and other therapies for OSA-induced dysmetabolism are needed. Animal models of time restricted eating (TRE) demonstrate an improvement in glucose and lipid metabolism, even in the absence of a reduction of caloric intake. Some human studies have shown an improvement in metabolic dysfunction with TRE, though further well-designed studies are needed. The effects of TRE on metabolic dysfunction in patients with OSA, a population with a high predisposition to metabolic disorder, has never been examined. In this study, we will conduct a randomized clinical trial to assess the feasibility and efficacy of 12 weeks of TRE, versus standard eating (SE), to improve glucose regulation and cardiovascular health of participants with OSA.
Read the detailed description
This study involves several visits:
- Those participants who fulfill inclusion criteria and are not excluded by virtue of any of the exclusion criteria will be asked to come to the University of California San Diego for visit 1. At this visit, participants will fill out consent form, will have a fasting blood draw, will have vitals checked, will fill out a quality-of-life questionnaire (SF-36), will have a continuous glucose monitor (CGM) applied, and will be given an Actiwatch to wear during the baseline/screening period. Participants will also download the myCircadianClock (mCC) app, be provided a unique access code to log in, and be trained on how to use the mCC app to document food and beverages. Study coordinators will help participants download the app. This will be the beginning of the 2-week baseline/screening period.
1a. During the 2-week baseline/screening period, all participants will be asked to maintain their current lifestyle, and record all of their dietary intake (by taking photos and/or annotating all of the food/beverages they consume) with the mCC app. These data will be used to determine the participants' baseline eating window. Participants will also receive regular nudges from the mCC app (reminders and tips) and educational blogs. During baseline, participants will also continue to wear the CGM and Actiwatch. Participants are asked not to significantly change their diet (e.g., start a new diet program) at any point during the study.
- At the end of the screening period, participants will go to ACTRI Visit 2. There, participants will have their CGM removed and will return their Actiwatch. Participants with an eating window of ≥12 h, have sufficient logging, and pass all inclusion/exclusion criteria will be randomized to SE or TRE for intervention. All participants will meet with a dietician for a 24-hour dietary recall, will receive instruction and written information on how to follow the intervention they were assigned and to what to expect throughout the study, and will schedule future visits when possible. The TRE group will be asked to limit their food intake to a consistent, self-selected, 10 hour period daily, during which they will consume all caloric intake. Water and medications will be allowed outside this window. Otherwise, these participants will be asked to continue their normal daily routine. The SE group will be asked to continue their routine as they were.
2a. During the 12 weeks of monitored/guided intervention, all participants will continue to log all of their food and beverages into the mCC app. Every two weeks they will have a phone call or video visit with a member of the research team. At these virtual visits, participants will discuss their experience with the study intervention, including any barriers to adherence or points of clarification.
- At week 10 of the intervention period, participants will return for ACTRI Visit 3. At this visit, they will have a CGM applied and be provided an Actiwatch to wear for the following two weeks. They will also discuss their experience with the study. Finally, participants will be provided with a home sleep apnea test device, in order to determine OSA severity at the end of the study period.
- At week 12 of the intervention period, participants will return for ACTRI visit 4. At this visit, participants will repeat all assays at baseline (fasting blood draw, vitals, questionnaires, 24-h dietary recall), have their CGM removed, and return the Actiwatch. They will also provide feedback on their experience in the study, and home sleep apnea test equipment will be collected and downloaded. If participants wish, study coordinators will help them delete the mCC app from their smartphones.
- Conditions
- Time Restricted Eating, Obstructive Sleep Apnea
- Being tested
- Time restricted eating
- Keywords
- hyperglycemia, intermittent fasting, sleep apnea, weight loss, hyperlipidemia, metabolic syndrome
- Medical subject headings
- Intermittent Fasting, Sleep Apnea, Obstructive, Hyperglycemia, Sleep Apnea Syndromes, Weight Loss, Hyperlipidemias, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time restricted eatingBehavioural
Caloric intake restricted to a self-defined 8-10 hour window in each 24-hour period.
| Study group | Role | What they receive |
|---|---|---|
| Time restricted eating | Experimental | Caloric intake restricted to a self-defined 8-10 hour window in each 24-hour period, for 12 weeks. Receives: Behavioral: Time restricted eating |
| Standard eating | No intervention | Normal eating schedule. Participants are expected to maintain their normal eating and dietary habits. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of TRE vs SE on change in mean daily glucose level
Change in mean daily glucose level over the study duration (measured in mg/dL), derived from continuous glucose monitoring (CGM), is the primary outcome.
Measured: 12 weeks
Effect of TRE vs SE on change in serum LDL cholesterol
Change in serum LDL (mg/dL), based on fasting blood draws, will be compared between TRE and SE groups.
Measured: 12 weeks
Effect of TRE vs SE on change in OSA severity
Change in OSA severity (apnea-hypopnea index, number of events per hour) will be compared versus pre-enrollment data.
Measured: 12 weeks
Effect of TRE on quality of life
Change in quality of life, based on the Short Form (36) Health Survey, will be compared in TRE and SE groups. This survey is a patient-reported scale measuring overall health. It features eight scaled scores, where the scores are the weighted sums in each section (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health). Scores range from 0-100 where lower scores mean more disability, and higher scores mean higher disability.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start5 Jan 2024
- Primary completionJul 2027 (estimated)
- Study completionDec 2028 (estimated)
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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a parallel study design of TRE vs SE on the outcomes listed. 80 participants will be recruited (40 per group) with an interim analysis performed after 34 participants are recruited (17 per group).
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Mesarwi, University of California, San Diego
- Investigators
- Omar Mesarwi, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06047496
- Sponsor's protocol ID
- 807206
- Acronym
- TERESA
- Status last verified
- Jan 2024
- First submitted
- 25 Aug 2023
- Last updated
- 16 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Time Restricted Eating in Sleep Apnea Study
- ClinicalTrials.gov ID
- NCT06047496
- Acronym / sponsor ID
- TERESA / 807206
- Conditions
- Time Restricted Eating, Obstructive Sleep Apnea
- Keywords
- hyperglycemia, intermittent fasting, sleep apnea, weight loss, hyperlipidemia, metabolic syndrome
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 5 Jan 2024 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 21 Sep 2023 (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.
Obstructive sleep apnea (OSA) is a highly prevalent disorder that is associated with both cardiovascular and metabolic dysfunction, such as hypertension, increased blood glucose levels and diabetes, obesity, and nonalcoholic fatty liver. While continuous positive airway pressure (CPAP), the best available OSA treatment, has been shown to improve blood pressure in OSA, it does not appear to improve metabolic consequences of OSA, and other therapies for OSA-induced dysmetabolism are needed. Animal models of time restricted eating (TRE) demonstrate an improvement in glucose and lipid metabolism, even in the absence of a reduction of caloric intake. Some human studies have shown an improvement in metabolic dysfunction with TRE, though further well-designed studies are needed. The effects of TRE on metabolic dysfunction in patients with OSA, a population with a high predisposition to metabolic disorder, has never been examined. In this study, we will conduct a randomized clinical trial to assess the feasibility and efficacy of 12 weeks of TRE, versus standard eating (SE), to improve glucose regulation and cardiovascular health of participants with OSA.
Detailed description
This study involves several visits:
- Those participants who fulfill inclusion criteria and are not excluded by virtue of any of the exclusion criteria will be asked to come to the University of California San Diego for visit 1. At this visit, participants will fill out consent form, will have a fasting blood draw, will have vitals checked, will fill out a quality-of-life questionnaire (SF-36), will have a continuous glucose monitor (CGM) applied, and will be given an Actiwatch to wear during the baseline/screening period. Participants will also download the myCircadianClock (mCC) app, be provided a unique access code to log in, and be trained on how to use the mCC app to document food and beverages. Study coordinators will help participants download the app. This will be the beginning of the 2-week baseline/screening period.
1a. During the 2-week baseline/screening period, all participants will be asked to maintain their current lifestyle, and record all of their dietary intake (by taking photos and/or annotating all of the food/beverages they consume) with the mCC app. These data will be used to determine the participants' baseline eating window. Participants will also receive regular nudges from the mCC app (reminders and tips) and educational blogs. During baseline, participants will also continue to wear the CGM and Actiwatch. Participants are asked not to significantly change their diet (e.g., start a new diet program) at any point during the study.
- At the end of the screening period, participants will go to ACTRI Visit 2. There, participants will have their CGM removed and will return their Actiwatch. Participants with an eating window of ≥12 h, have sufficient logging, and pass all inclusion/exclusion criteria will be randomized to SE or TRE for intervention. All participants will meet with a dietician for a 24-hour dietary recall, will receive instruction and written information on how to follow the intervention they were assigned and to what to expect throughout the study, and will schedule future visits when possible. The TRE group will be asked to limit their food intake to a consistent, self-selected, 10 hour period daily, during which they will consume all caloric intake. Water and medications will be allowed outside this window. Otherwise, these participants will be asked to continue their normal daily routine. The SE group will be asked to continue their routine as they were.
2a. During the 12 weeks of monitored/guided intervention, all participants will continue to log all of their food and beverages into the mCC app. Every two weeks they will have a phone call or video visit with a member of the research team. At these virtual visits, participants will discuss their experience with the study intervention, including any barriers to adherence or points of clarification.
- At week 10 of the intervention period, participants will return for ACTRI Visit 3. At this visit, they will have a CGM applied and be provided an Actiwatch to wear for the following two weeks. They will also discuss their experience with the study. Finally, participants will be provided with a home sleep apnea test device, in order to determine OSA severity at the end of the study period.
- At week 12 of the intervention period, participants will return for ACTRI visit 4. At this visit, participants will repeat all assays at baseline (fasting blood draw, vitals, questionnaires, 24-h dietary recall), have their CGM removed, and return the Actiwatch. They will also provide feedback on their experience in the study, and home sleep apnea test equipment will be collected and downloaded. If participants wish, study coordinators will help them delete the mCC app from their smartphones.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a parallel study design of TRE vs SE on the outcomes listed. 80 participants will be recruited (40 per group) with an interim analysis performed after 34 participants are recruited (17 per group).
| Arm | Type | Receives |
|---|---|---|
| Time restricted eating | Experimental | Behavioral: Time restricted eatingCaloric intake restricted to a self-defined 8-10 hour window in each 24-hour period, for 12 weeks. |
| Standard eating | No intervention | –Normal eating schedule. Participants are expected to maintain their normal eating and dietary habits. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Provision of signed and dated informed consent form;
- Stated willingness to comply with all study procedures and availability for the duration of the study;
- Be of appropriate age (18-70);
- Own a smartphone (Apple iOS or Android OS);
- Have a baseline eating period ≥12 hours/day and sufficient logging on the myCircadianClock app;
Key exclusion criteria (21 listed)
- Participants with type 1 or type 2 diabetes mellitus who are taking insulin or sulfonylureas, or any participant with a history of hypoglycemia unawareness
- OSA with evidence of significant sleepiness, as defined by either a) Epworth Sleepiness Score ≥15, or b) motor vehicle accident due to excessive sleepiness within the past year
- BMI >40 kg/m2
- Uncontrolled hypertension
- Active tobacco or illicit drug use
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 eatingCaloric intake restricted to a self-defined 8-10 hour window in each 24-hour period. | Behavioural | Time restricted eating |
Primary outcome
Effect of TRE vs SE on change in mean daily glucose level
Time frame: 12 weeks
Change in mean daily glucose level over the study duration (measured in mg/dL), derived from continuous glucose monitoring (CGM), is the primary outcome.
Effect of TRE vs SE on change in serum LDL cholesterol
Time frame: 12 weeks
Change in serum LDL (mg/dL), based on fasting blood draws, will be compared between TRE and SE groups.
Effect of TRE vs SE on change in OSA severity
Time frame: 12 weeks
Change in OSA severity (apnea-hypopnea index, number of events per hour) will be compared versus pre-enrollment data.
Effect of TRE on quality of life
Time frame: 12 weeks
Change in quality of life, based on the Short Form (36) Health Survey, will be compared in TRE and SE groups. This survey is a patient-reported scale measuring overall health. It features eight scaled scores, where the scores are the weighted sums in each section (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health). Scores range from 0-100 where lower scores mean more disability, and higher scores mean higher disability.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Omar Mesarwi, MD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Time restricted eating in people with Time Restricted Eating and Obstructive Sleep Apnea, run by University of California, San Diego 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 8 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 16 Jan 2024. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pamela DeYoung, RPSGT ((858) 246-2154, pdeyoung@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of TRE vs SE on change in mean daily glucose level (time frame: 12 weeks). The study lists 4 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 16 Jan 2024; AzTrials last refreshed its copy on 26 Oct 2026.