Night Shift WorkSHIFTNCT06891352
Optimization of Chrononutrition to Reduce the Risk of Disease in Shift Workers
A study testing Dietary Monitoring, Time-Restricted Eating (TRE) and Time-Restricted Eating with a Low-Glycemic Snack (TRE-LGS) in people with Night Shift Work and Time Restricted Eating, run by Salk Institute for Biological Studies at 1 site in United States.
Trial summary
In this randomized controlled trial, the investigators will assess the health impacts of optimizing the timing of dietary consumption in nurses and nursing assistants who work night shifts, have a habitual eating window of 14 hours or more, and elevated weight. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Night Shift Work, Time Restricted Eating, Overweight
- What is being tested?
- Dietary Monitoring, Time-Restricted Eating (TRE) and Time-Restricted Eating with a Low-Glycemic Snack (TRE-LGS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2025to 3 Mar 2029
- Phase
- Interventional
- 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
- Age: 18-70 years
- BMI ≥ 25 kg/m2 (or ≥ 23 kg/m2 for Asian adults)
- Own a smartphone (Apple iOS or Android OS)
- Baseline eating window ≥ 14 h/day
- Night shift nurses and nursing assistants who are working a 12-hour night shift at least 3 days/week.
- Have been doing night shift work for at least 3 months.
- Patients on cardiovascular medications (HMG CoA reductase inhibitors (statins), metformin, lipid-modifying drugs (including over-the-counter drugs such as red yeast rice and fish oil), anti-hypertensive, drugs), are allowed
- If patients have Type 2 Diabetes, they will be included in the study if A1c is less than 9 and they are not on insulin.
Who cannot join
- Insufficient dietary logging on the mCC app is defined as less than 7 of 14 days of baseline of dietary logging with a minimum of 2 items a day, at least 5 hours apart.
- Type 1 Diabetes or Insulin-dependent Type 2 Diabetes.
- Use of sulfonylurea or insulin within the last 3 months (due to unknown safety with TRE)
- Use of medications that are known to cause weight loss such as SGLT2 inhibitors and GLP1 receptor agonists)
- BMI > 50 kg/m2
- Change in medications that could impact study outcomes within the past 3 months
Show all 27Show fewer
- Change in weight of >4kg in the past 3 months
- Women who are pregnant, breastfeeding, or are trying to become pregnant during the study period. If a participant becomes pregnant during the study, they will be excluded from continuing the study.
- Systolic BP greater than 160 mmHg and/or diastolic BP greater than 110 mmHg at rest
- Fasting LDL cholesterol greater than 250 mg/dL
- Fasting triglycerides greater than 500g/dL
- Active tobacco abuse or illicit drug use or history of treatment for alcohol abuse in the past 5 years.
- Frequent (more than 4) travel involving a time zone change of more than 3 hours over the 1-year study period
- Prolonged leave from work (a continuous month or longer) during the study
- Active treatment for inflammatory and/or rheumatologic disease
- History of a major adverse cardiovascular event within the past year (acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass graft surgery, hospitalization for congestive heart failure, stroke/transient ischemic attack)
- Uncontrolled arrhythmia (i.e. rate-controlled atrial fibrillation/atrial flutter are acceptable)
- History of thyroid disease requiring dose titration of thyroid replacement medication(s) within the past 3 months (hypothyroidism on a stable dose of thyroid replacement therapy is allowed).
- History of adrenal disease in the past 5 years
- History of malignancy undergoing active treatment, except non-melanoma skin cancer, in the past 5 years
- History of an eating disorder in the past 5 years
- History of cirrhosis in the past 5 years
- History of stage 4 or 5 chronic kidney disease or dialysis in the past 5 years
- History of HIV/AIDs
- Currently enrolled in weight-loss or weight-management program
- History of surgical intervention for weight management within the past 2 years, or longer if deemed unsafe following review by medical investigators
- Uncontrolled psychiatric disorder including prior hospitalization
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 Altman Clinical and Translational Research Institute
La Jolla, California, 92037
UCSD Study Coordinator, 858-246-2342, research@mycircadianclock.org
Salk Clinical Researcher, 858-453-4100 ext. 1077, research@mycircadianclock.org
About this study
Official title: Optimization of Chrononutrition to Reduce the Risk of Disease in Shift Workers - The SHIFT Study
In this randomized controlled trial, the investigators will assess the health impacts of optimizing the timing of dietary consumption in nurses and nursing assistants who work night shifts, have a habitual eating window of 14 hours or more, and elevated weight. Participants will be randomized to one of three groups: (1) dietary monitoring, (2) dietary monitoring plus 10-hour daytime time-restricted eating (TRE), or (3) TRE with a low-glycemic snack during night shifts. The study includes a 2-week screening/baseline health assessment, with follow-up health assessments at 3-, 6- (primary outcome), and 12 months.
Read the detailed description
The purpose of this study is to assess if reducing the number of hours during which participants eat each day, and consolidating dietary intake to the daytime, (with or without a low glycemic snack during night shifts) will help decrease weight and abdominal fat, improve glucose (sugar) regulation, and improve other markers of metabolic and cardiovascular health (i.e. lipid levels, inflammation markers, etc.).
Circadian clocks ("circa" means approximately and "dian" means day) are daily rhythms in physiology and behavior (activity, sleep, eating pattern) that help our body to anticipate and adapt to predictable events in the environment. These rhythms are generated and maintained by biological clocks that are present in the brain and almost every organ of our body. Remarkably, even in the absence of any timing information from a device, our body can keep track of time and thereby help us go to sleep and eat at optimum times. However, our lifestyle and work schedules can lead us to eat, exercise, and sleep at times that the clocks in our body are not prepared for. When these abnormal daily patterns continue for several weeks or years, it can affect our health in many ways including increased body weight, poor sleep, and elevated risk for various chronic diseases. Time-restricted eating (TRE), which restricts all dietary intake to a personalized consistent daily eating window to support circadian rhythms, has been shown to improve cardiometabolic health. However, TRE has not yet been assessed in people who work night shifts.
In this study, the investigators are interested in evaluating the effects of modifying eating patterns on the health of nurses and nursing assistants who work night shifts. Participants will be randomized to (1) dietary monitoring alone, or in combination with, (2) personalized 10-hour TRE (TRE), or (3) personalized 10-hour TRE with a low-glycemic snack provided to consume during night shifts (TRE-LGS). The TRE group will only be allowed water, black coffee, and tea (without any additives such as cream, sweetener including artificial sweeteners), during night shifts. The TRE+LGS group will be provided a low glycemic snack during night shifts.
The study is a year-long including a 2-week screening/baseline assessment, a 6-month guided intervention, and a 6-month self-guided intervention. Health assessments will be taken at screening/baseline, 3 months, 6 months (primary outcome), and 1 year (follow-up). Assessments will include weight (in clinic and at home), blood pressure (in clinic and at home), dietary recall (ASA24), body mass index, blood tests (biomarkers of cardiometabolic health parameters), glycemic regulation (Continuous Glucose Monitors), body composition ( duel energy x-ray absorptiometry, DXA), dietary intake (logged on the myCircadianClock smartphone app), sleep and quality of life questionnaires, and activity, sleep, and wrist temperature (actigraphy watch).
- Conditions
- Night Shift Work, Time Restricted Eating, Overweight, Obesity
- Being tested
- Dietary Monitoring, Time-Restricted Eating (TRE), Time-Restricted Eating with a Low-Glycemic Snack (TRE-LGS)
- Keywords
- Time-Restricted Eating, Night Shift work, Nurses, Nursing Assistants
- Medical subject headings
- Intermittent Fasting, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary MonitoringBehavioural
Participants in the group will receive standard advice for a healthy lifestyle, log all food and beverage intake on the myCircadianClock app, and continue their habitual eating patterns.
Time-Restricted Eating (TRE)Behavioural
Participants in the group will receive standard advice for a healthy lifestyle, log all food and beverage intake on the myCircadianClock app, and adhere to a personalized consistent 10-hour time-restricted eating window.
Time-Restricted Eating with a Low-Glycemic Snack (TRE-LGS)Behavioural
Participants in the group will receive standard advice for a healthy lifestyle, log all food and beverage intake on the myCircadianClock app, and adhere to a personalized consistent 10-hour time-restricted eating window. On nights that participants work night shifts, they will consume a low-glycemic snack provided by the research team.
| Study group | Role | What they receive |
|---|---|---|
| Dietary Monitoring | Active comparator | Log all dietary intake and continue habitual eating patterns. Receives: Behavioral: Dietary Monitoring |
| Time-Restricted Eating (TRE) | Experimental | Dietary Monitoring and adherence to a personalized consistent 10-hour time-restricted eating window Receives: Behavioral: Time-Restricted Eating (TRE) |
| Time-Restricted Eating with Low-Glycemic Snack (TRE-LGS) | Experimental | Dietary Monitoring and adherence to a modified personalized consistent 10-hour time-restricted eating window a low-glycemic snack provided by the research team to consume during night shifts. Receives: Behavioral: Time-Restricted Eating with a Low-Glycemic Snack (TRE-LGS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Body Fat Mass (kg)
Total Body Fat Mass (kg) assessed by DXA
Measured: Baseline, 3 month, 6 month (primary), and 12 month (follow-up)
Secondary outcomes (13)
Body weight (kg) in clinic
Body weight (kg) measured in clinic while participants are wearing a gown that has been weighed.
Measured: Baseline, 3 month, 6 month (primary), and 12 month (follow-up)
Body Mass Index
Body Mass Index (BMI) (kg/m2)
Measured: Baseline, 3 month, 6 month (primary), and 12 month (follow-up)
HbA1c (%)
Hemoglobin A1c (%) from fasted blood draw
Measured: Baseline, 3 month, 6 month (primary), and 12 month (follow-up)
Intra-Daily Glycemic Variability: CONGA (A.U.)
Continuous Overall Net Glycemic Action (CONGA) assessed via continuous glucose monitor
Measured: Baseline, 3 month, 6 month (primary), and 12 month (follow-up)
Inter-Daily Glycemic Variability: MODD (mg/dL)
Mean of Daily Differences (MODD) assessed via continuous glucose monitor
Measured: Baseline, 3 month, 6 month (primary), and 12 month (follow-up)
Glycemic Variability: MAGE (mg/dL)
Mean Amplitude of Glycemic Excursions (MAGE) assessed by continuous glucose monitor
Measured: Baseline, 3 month, 6 month (primary), and 12 month (follow-up)
Mean Glucose (mg/dL)
Mean Glucose assessed by continuous glucose monitor
Measured: Baseline, 3 month, 6 month (primary), and 12 month (follow-up)
Fasting Glucose (mg/dL)
Blood glucose assessed from a fasted blood draw
Measured: Baseline, 3 month, 6 month (primary), and 12 month (follow-up)
Fasting Insulin (uIU/mL)
Blood insulin assessed from a fasted blood draw
Measured: Baseline, 3 month, 6 month (primary), and 12 month (follow-up)
Blood Pressure (mmHg)
Systolic and Diastolic Blood Pressure taken in clinic.
Measured: Baseline, 3 month, 6 month (primary), and 12 month (follow-up)
Blood Pressure (mmHg)_at home measurements
Systolic and Diastolic blood pressure taken at home. Measurements are taken twice (one measurement on a work day and one on an off day) during the 2 week assessment periods. Each day measurements will be taken 3 times throughout the day. Averages for work days and off days will be reported for each time point. Averages at each time point will be reported.
Measured: Baseline, 3 month, 6 month (primary), and 12 month (follow-up)
Direct LDL Cholesterol (mg/dL)
Direct LDL cholesterol from fasted blood draw
Measured: Baseline, 3 month, 6 month (primary), and 12 month (follow-up)
Non-HDL Cholesterol (mg/dL)
Non-HDL cholesterol from fasted blood draw
Measured: Baseline, 3 month, 6 month (primary), and 12 month (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start2 Jun 2025
- Primary completion31 Aug 2028 (estimated)
- Study completion3 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Night Shift WorkStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Salk Institute for Biological Studies
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of San Diego
- Responsible party
- Principal investigator, Emily N.C. Manoogian, Salk Institute for Biological Studies
- Investigators
- Emily Manoogian, Ph.D., Principal investigator, Salk Institute for Biological Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06891352
- Sponsor's protocol ID
- 24-0002
- Other IDs
- 1R01DK139356-01
- Acronym
- SHIFT
- Status last verified
- Dec 2025
- First submitted
- 12 Mar 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will report deidentified individual participant data for outcomes that are reported in scientific publications (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Chrononutrition to Reduce the Risk of Disease in Shift Workers - The SHIFT Study
- ClinicalTrials.gov ID
- NCT06891352
- Acronym / sponsor ID
- SHIFT / 24-0002
- Conditions
- Night Shift Work, Time Restricted Eating, Overweight, Obesity
- Keywords
- Time-Restricted Eating, Night Shift work, Nurses, Nursing Assistants
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Salk Institute for Biological StudiesUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of San Diego
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 3 Mar 2029 (estimated)
- First posted
- 24 Mar 2025 (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.
In this randomized controlled trial, the investigators will assess the health impacts of optimizing the timing of dietary consumption in nurses and nursing assistants who work night shifts, have a habitual eating window of 14 hours or more, and elevated weight. Participants will be randomized to one of three groups: (1) dietary monitoring, (2) dietary monitoring plus 10-hour daytime time-restricted eating (TRE), or (3) TRE with a low-glycemic snack during night shifts. The study includes a 2-week screening/baseline health assessment, with follow-up health assessments at 3-, 6- (primary outcome), and 12 months.
Detailed description
The purpose of this study is to assess if reducing the number of hours during which participants eat each day, and consolidating dietary intake to the daytime, (with or without a low glycemic snack during night shifts) will help decrease weight and abdominal fat, improve glucose (sugar) regulation, and improve other markers of metabolic and cardiovascular health (i.e. lipid levels, inflammation markers, etc.).
Circadian clocks ("circa" means approximately and "dian" means day) are daily rhythms in physiology and behavior (activity, sleep, eating pattern) that help our body to anticipate and adapt to predictable events in the environment. These rhythms are generated and maintained by biological clocks that are present in the brain and almost every organ of our body. Remarkably, even in the absence of any timing information from a device, our body can keep track of time and thereby help us go to sleep and eat at optimum times. However, our lifestyle and work schedules can lead us to eat, exercise, and sleep at times that the clocks in our body are not prepared for. When these abnormal daily patterns continue for several weeks or years, it can affect our health in many ways including increased body weight, poor sleep, and elevated risk for various chronic diseases. Time-restricted eating (TRE), which restricts all dietary intake to a personalized consistent daily eating window to support circadian rhythms, has been shown to improve cardiometabolic health. However, TRE has not yet been assessed in people who work night shifts.
In this study, the investigators are interested in evaluating the effects of modifying eating patterns on the health of nurses and nursing assistants who work night shifts. Participants will be randomized to (1) dietary monitoring alone, or in combination with, (2) personalized 10-hour TRE (TRE), or (3) personalized 10-hour TRE with a low-glycemic snack provided to consume during night shifts (TRE-LGS). The TRE group will only be allowed water, black coffee, and tea (without any additives such as cream, sweetener including artificial sweeteners), during night shifts. The TRE+LGS group will be provided a low glycemic snack during night shifts.
The study is a year-long including a 2-week screening/baseline assessment, a 6-month guided intervention, and a 6-month self-guided intervention. Health assessments will be taken at screening/baseline, 3 months, 6 months (primary outcome), and 1 year (follow-up). Assessments will include weight (in clinic and at home), blood pressure (in clinic and at home), dietary recall (ASA24), body mass index, blood tests (biomarkers of cardiometabolic health parameters), glycemic regulation (Continuous Glucose Monitors), body composition ( duel energy x-ray absorptiometry, DXA), dietary intake (logged on the myCircadianClock smartphone app), sleep and quality of life questionnaires, and activity, sleep, and wrist temperature (actigraphy watch).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dietary Monitoring | Active comparator | Behavioral: Dietary MonitoringLog all dietary intake and continue habitual eating patterns. |
| Time-Restricted Eating (TRE) | Experimental | Behavioral: Time-Restricted Eating (TRE)Dietary Monitoring and adherence to a personalized consistent 10-hour time-restricted eating window |
| Time-Restricted Eating with Low-Glycemic Snack (TRE-LGS) | Experimental | Behavioral: Time-Restricted Eating with a Low-Glycemic Snack (TRE-LGS)Dietary Monitoring and adherence to a modified personalized consistent 10-hour time-restricted eating window a low-glycemic snack provided by the research team to consume during night shifts. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age: 18-70 years
- BMI ≥ 25 kg/m2 (or ≥ 23 kg/m2 for Asian adults)
- Own a smartphone (Apple iOS or Android OS)
- Baseline eating window ≥ 14 h/day
- Night shift nurses and nursing assistants who are working a 12-hour night shift at least 3 days/week.
Key exclusion criteria (27 listed)
- Insufficient dietary logging on the mCC app is defined as less than 7 of 14 days of baseline of dietary logging with a minimum of 2 items a day, at least 5 hours apart.
- Type 1 Diabetes or Insulin-dependent Type 2 Diabetes.
- Use of sulfonylurea or insulin within the last 3 months (due to unknown safety with TRE)
- Use of medications that are known to cause weight loss such as SGLT2 inhibitors and GLP1 receptor agonists)
- BMI > 50 kg/m2
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 |
|---|---|---|
| Dietary MonitoringParticipants in the group will receive standard advice for a healthy lifestyle, log all food and beverage intake on the myCircadianClock app, and continue their habitual eating patterns. | Behavioural | Dietary Monitoring |
| Time-Restricted Eating (TRE)Participants in the group will receive standard advice for a healthy lifestyle, log all food and beverage intake on the myCircadianClock app, and adhere to a personalized consistent 10-hour time-restricted eating window. | Behavioural | Time-Restricted Eating (TRE) |
| Time-Restricted Eating with a Low-Glycemic Snack (TRE-LGS)Participants in the group will receive standard advice for a healthy lifestyle, log all food and beverage intake on the myCircadianClock app, and adhere to a personalized consistent 10-hour time-restricted eating window. On nights that participants work night shifts, they will consume a low-glycemic snack provided by the research team. | Behavioural | Time-Restricted Eating with Low-Glycemic Snack (TRE-LGS) |
Primary outcome
Total Body Fat Mass (kg)
Time frame: Baseline, 3 month, 6 month (primary), and 12 month (follow-up)
Total Body Fat Mass (kg) assessed by DXA
13 secondary outcomes
Body weight (kg) in clinic
Time frame: Baseline, 3 month, 6 month (primary), and 12 month (follow-up)
Body Mass Index
Time frame: Baseline, 3 month, 6 month (primary), and 12 month (follow-up)
HbA1c (%)
Time frame: Baseline, 3 month, 6 month (primary), and 12 month (follow-up)
Intra-Daily Glycemic Variability: CONGA (A.U.)
Time frame: Baseline, 3 month, 6 month (primary), and 12 month (follow-up)
Inter-Daily Glycemic Variability: MODD (mg/dL)
Time frame: Baseline, 3 month, 6 month (primary), and 12 month (follow-up)
Glycemic Variability: MAGE (mg/dL)
Time frame: Baseline, 3 month, 6 month (primary), and 12 month (follow-up)
Mean Glucose (mg/dL)
Time frame: Baseline, 3 month, 6 month (primary), and 12 month (follow-up)
Fasting Glucose (mg/dL)
Time frame: Baseline, 3 month, 6 month (primary), and 12 month (follow-up)
Fasting Insulin (uIU/mL)
Time frame: Baseline, 3 month, 6 month (primary), and 12 month (follow-up)
Blood Pressure (mmHg)
Time frame: Baseline, 3 month, 6 month (primary), and 12 month (follow-up)
Blood Pressure (mmHg)_at home measurements
Time frame: Baseline, 3 month, 6 month (primary), and 12 month (follow-up)
Direct LDL Cholesterol (mg/dL)
Time frame: Baseline, 3 month, 6 month (primary), and 12 month (follow-up)
Non-HDL Cholesterol (mg/dL)
Time frame: Baseline, 3 month, 6 month (primary), and 12 month (follow-up)
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 17 Dec 2025.
- Individual participant dataSharing planned: Yes. We will report deidentified individual participant data for outcomes that are reported in scientific publications (text, tables, figures, and appendices).
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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.
Emily Manoogian, Ph.D. principal investigator
Salk Institute for Biological Studies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Monitoring, Time-Restricted Eating (TRE) and Time-Restricted Eating with a Low-Glycemic Snack (TRE-LGS) in people with Night Shift Work and Time Restricted Eating, run by Salk Institute for Biological Studies 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 27 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 17 Dec 2025. 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?
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 UCSD Study Coordinator (858-246-2342, research@mycircadianclock.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Body Fat Mass (kg) (time frame: Baseline, 3 month, 6 month (primary), and 12 month (follow-up)). 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 17 Dec 2025.