Metabolic SyndromeTIMETNCT04057339
The Influence of Time-Restricted Eating in Patients With Metabolic Syndrome
A study of Metabolic Syndrome and Pre-Diabetes, run by University of California, San Diego at 1 site in United States.
Trial summary
In a randomized controlled trial, the investigators intend to measure the health impact of TRE in patients with metabolic syndrome (with three or more of the following criteria: increased waist circumference, abnormal cholesterol levels, elevated blood pressure, or elevated blood sugar), who habitually eat for more… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metabolic Syndrome, Pre-Diabetes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2019to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years
- 41 ≥ BMI ≥ 25 AND
- Metabolic syndrome, as defined as presence of 3 or more of the following criteria:
- Elevated fasting plasma glucose ≥ 100 mg/dL and/or HbA1c ≥ 5.7% < 7.1% Elevated waist circumference: In Asians: ≥ 90 cm in men, ≥ 80 cm in women, all other races: ≥ 102 cm in men, ≥ 88 cm in women Fasting plasma triglycerides ≥ 150 mg/dL, or on drug treatment for elevated triglycerides Reduced High-density lipoprotein (HDL)-cholesterol < 40 mg/dL in males or < 50 mg/dL in females, or drug treatment for reduced HDL-cholesterol Elevated blood pressure, Systolic blood pressure ≥ 135 mm Hg and/or diastolic blood pressure ≥ 85 mm Hg or drug treatment for hypertension
- Own a smartphone (Apple iOS or Android OS)
- Baseline eating period ≥ 12 hour window
- If patients are on cardiovascular medications (HMG CoA reductase inhibitors (statins), other lipid modifying drugs (including over the counter drugs such as red yeast rice and fish oil), anti-hypertensive, anti-diabetes drugs), no dose adjustments will be allowed during the study period.
Who cannot join
- Taking insulin within the last 6 months.
- Manifest diabetes, defined as HbA1c > 7.0% given a 0.3% margin of error in lab readings, or diagnosis of diabetes.
- Known inflammatory and/or rheumatologic disease.
- Active tobacco abuse or illicit drug use or history of treatment for alcohol abuse.
- Pregnant or breast-feeding women.
- Shift workers with variable (e.g. nocturnal) hours.
Show all 26Show fewer
- Caregivers for dependent requiring frequent nocturnal care/sleep interruptions.
- Planned travel to a time zone with greater than a 3-hour difference during study period.
- History of major adverse cardiovascular event within the past 1 year (acute coronary syndrome (ACS), percutaneous coronary intervention, coronary artery bypass graft surgery, hospitalization for congestive heart failure, stroke/transient ischemic attack (TIA)).
- Uncontrolled arrhythmia (i.e. rate-controlled atrial fibrillation/atrial flutter are not exclusion criteria).
- History of 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).
- History of adrenal disease.
- History of malignancy undergoing active treatment, except non-melanoma skin cancer.
- Known history of type I diabetes.
- History of eating disorder(s).
- History of cirrhosis.
- History of stage 4 or 5 chronic kidney disease or requiring dialysis.
- History of HIV/AIDS.
- Currently enrolled in a weight-loss or weight-management program.
- On a special or prescribed diet for other reasons (e.g. Celiac disease).
- Currently taking any medication that is meant for, or has known effect on, appetite.
- Any history of surgical intervention for weight management.
- Uncontrolled psychiatric disorder (including history of hospitalization for psychiatric illness).
- A score of >16 on the Epworth Sleepiness Scale (ESS).
- Depression determined by the Beck Depression Inventory (BDI) (unless previously diagnosed and well-controlled).
- Failure to use the smartphone app for documentation (defined as <2 meals/day for ≥3 days during baseline).
Trial locations and contacts
1 site in 1 country.
United States1 site
Altman Clinical and Translational Research Institute
La Jolla, California, 92093
About this study
Official title: Influence of Time-restricted Eating (TRE) on Circadian Regulation of Glucose Homeostasis and Mitochondrial Function - The TIMET Study
In a randomized controlled trial, the investigators intend to measure the health impact of TRE in patients with metabolic syndrome (with three or more of the following criteria: increased waist circumference, abnormal cholesterol levels, elevated blood pressure, or elevated blood sugar), who habitually eat for more than 14 hours every day. Patients will be randomly assigned to a control group of behavioral nutrition counseling (standard of care) or the intervention group of behavioral nutrition counseling with the addition of adopting a 8-10 hour eating window for 12 weeks (TRE).
Read the detailed description
Circadian rhythms optimize nutrient homeostasis by orchestrating catabolic and anabolic metabolism to appropriate times of the 24 hour day. Chronic circadian rhythm disruption predisposes individuals to metabolic diseases including obesity and type 2 diabetes. Conversely, maintaining a daily rhythm of feeding and fasting cycles sustains a robust circadian rhythm which improves cellular bioenergetics and results in improved metabolism. Time-restricted eating (TRE) is a specific feeding-fasting pattern in which feeding is restricted to 8-12 hours a day.
At the beginning and end of the study (which will be three months in duration), the following parameters will be measured: height, weight, body mass index, percent body fat, waist/hip circumference and blood pressure. Blood sugar levels will be monitored continuously for 2 weeks at a time at the beginning and end of the study using a continuous glucose monitor. Additionally, a dual energy X-ray absorptiometry (DXA) scan will be used to collect information about body composition. Information will be collected about the mitochondria with a muscle biopsy. Participants will use a smartphone application (called myCircadianClock (mCC), developed by the Salk Institute) to keep track of food/beverage intake and will wear a wrist-worn actigraphy device to monitor physical activity levels and sleep.
- Conditions
- Metabolic Syndrome, Pre-Diabetes
- Being tested
- Time Restricted Eating + Standard of Care, Standard of Care
- Keywords
- Time Restricted Eating, Circadian Rhythm, Glucose Homeostasis, Mitochondrial Function, Fasting
- Medical subject headings
- Metabolic Syndrome, Glucose Intolerance, Intermittent Fasting, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time Restricted Eating + Standard of CareBehavioural
Also called Time Restricted Eating
Participants in this arm will adhere to a daily, consistent 8-10-hr eating window for the course of the study as well as receive nutritional counseling from the study dietitian.
Standard of CareBehavioural
Participants in this arm will receive nutritional counseling from the study dietician, but will not be required to adopt a 8-10-hr eating window.
| Study group | Role | What they receive |
|---|---|---|
| SOC (Standard of Care) | Placebo comparator | Everyone in this arm will receive standard of care nutritional behavioral counseling and will be required to log their caloric intake through the use of a smartphone app. Receives: Behavioral: Standard of Care |
| TRE + SOC | Experimental | Everyone in this arm will receive standard of care nutritional behavioral counseling and will implement a daily 8-10-hour window within which they must consume their calories. They will also be required to log their caloric intake through the use of a smartphone app. Receives: Behavioral: Time Restricted Eating + Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Glucose Levels Assessed Via HbA1c
HbA1c (%)
Measured: Baseline and 14 weeks
Change in Glycemic Parameters Assessed Via Fasting Glucose
Glycemic parameters assessed via fasting glucose (mg/dL)
Measured: Baseline and 14 weeks
Change in Glycemic Parameters Assessed Via HOMA-IR
Glycemic parameters assessed via HOMA-IR (Homeostatic Model Assessment of Insulin Resistance) - a calculated index estimating insulin resistance from fasting blood glucose and insulin levels, using the formula (fasting glucose × fasting insulin) ÷ 405. Lower scores indicate healthier insulin sensitivity, while higher scores indicate greater insulin resistance.
Measured: Baseline and 14 weeks
Glycemic Parameters Assessed Via Fasting Insulin
Glycemic parameters assessed via fasting insulin (μIU/mL)
Measured: Baseline and 14 weeks
Glycemic Parameters Assessed Via CGM Mean Glucose
Glycemic parameters assessed via CGM mean glucose (mg/dL).
Measured: Baseline and 14 weeks
Glycemic Parameters Assessed Via CGM CONGA
Glycemic parameters assessed via CGM CONGA (Continuous Overall Net Glycemic Action)
Measured: Baseline and 14 weeks
Glycemic Parameters Assessed Via CGM MODD
Glycemic parameters assessed via CGM MODD (mg/dL)
Measured: Baseline and 14 weeks
Secondary outcomes (6)
Change in LDL Particle Number
LDL particle number (nmol/L) via NMR lipoprofile
Measured: Baseline and 14 weeks
Change in LDL Cholesterol
LDL cholesterol (mg/dl)
Measured: Baseline and 14 weeks
Change in HDL Cholesterol
HDL cholesterol (mg/dl)
Measured: Baseline and 14 weeks
Change in Triglycerides
Triglycerides (mg/dl)
Measured: Baseline and 14 weeks
Change in Body Composition by DXA
Lower abdominal fat mass as assessed by dual-energy X-ray absorptiometry (DXA).
Measured: Baseline and 14 weeks
Change in Hs-CRP
High sensitivity C-reactive protein (mg/L)
Measured: Baseline and 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start8 Apr 2019
- Primary completion19 Jan 2023
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Salk Institute for Biological Studies
- Responsible party
- Principal investigator, Pam Taub, MD, University of California, San Diego
- Investigators
- Pam Taub, MD, Principal investigator, Associate Professor of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04057339
- Sponsor's protocol ID
- 181088
- Other IDs
- 1R01DK118278-01
- Acronym
- TIMET
- Status last verified
- May 2026
- First submitted
- 2 Apr 2019
- Last updated
- 30 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified participant data used for findings in publication are available at https://data.mendeley.com. Any other data or material requests will be fulfilled at the discretion of Dr. Panda and Dr. Taub.
Publications
Manoogian ENC, Wilkinson MJ, O'Neal M, Laing K, Nguyen J, Van D, Rosander A, Pazargadi A, Gutierrez NR, Fleischer JG, Golshan S, Panda S, Taub PR. Time-Restricted Eating in Adults With Metabolic Syndrome : A Randomized Controlled Trial. Ann Intern Med. 2024 Nov;177(11):1462-1470. doi: 10.7326/M24-0859. Epub 2024 Oct 1.
PubMed 39348690Taub PR, Panda S. Time for better time-restricted eating trials to lessen the burden of metabolic diseases. Cell Rep Med. 2022 Jun 21;3(6):100665. doi: 10.1016/j.xcrm.2022.100665.
PubMed 35732151
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Time-restricted Eating (TRE) on Circadian Regulation of Glucose Homeostasis and Mitochondrial Function - The TIMET Study
- ClinicalTrials.gov ID
- NCT04057339
- Acronym / sponsor ID
- TIMET / 181088
- Conditions
- Metabolic Syndrome, Pre-Diabetes
- Keywords
- Time Restricted Eating, Circadian Rhythm, Glucose Homeostasis, Mitochondrial Function, Fasting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Salk Institute for Biological Studies
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- 19 Jan 2023 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 15 Aug 2019 (actual)
- Results
- Posted 30 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In a randomized controlled trial, the investigators intend to measure the health impact of TRE in patients with metabolic syndrome (with three or more of the following criteria: increased waist circumference, abnormal cholesterol levels, elevated blood pressure, or elevated blood sugar), who habitually eat for more than 14 hours every day. Patients will be randomly assigned to a control group of behavioral nutrition counseling (standard of care) or the intervention group of behavioral nutrition counseling with the addition of adopting a 8-10 hour eating window for 12 weeks (TRE).
Detailed description
Circadian rhythms optimize nutrient homeostasis by orchestrating catabolic and anabolic metabolism to appropriate times of the 24 hour day. Chronic circadian rhythm disruption predisposes individuals to metabolic diseases including obesity and type 2 diabetes. Conversely, maintaining a daily rhythm of feeding and fasting cycles sustains a robust circadian rhythm which improves cellular bioenergetics and results in improved metabolism. Time-restricted eating (TRE) is a specific feeding-fasting pattern in which feeding is restricted to 8-12 hours a day.
At the beginning and end of the study (which will be three months in duration), the following parameters will be measured: height, weight, body mass index, percent body fat, waist/hip circumference and blood pressure. Blood sugar levels will be monitored continuously for 2 weeks at a time at the beginning and end of the study using a continuous glucose monitor. Additionally, a dual energy X-ray absorptiometry (DXA) scan will be used to collect information about body composition. Information will be collected about the mitochondria with a muscle biopsy. Participants will use a smartphone application (called myCircadianClock (mCC), developed by the Salk Institute) to keep track of food/beverage intake and will wear a wrist-worn actigraphy device to monitor physical activity levels and sleep.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SOC (Standard of Care) | Placebo comparator | Behavioral: Standard of CareEveryone in this arm will receive standard of care nutritional behavioral counseling and will be required to log their caloric intake through the use of a smartphone app. |
| TRE + SOC | Experimental | Behavioral: Time Restricted Eating + Standard of CareEveryone in this arm will receive standard of care nutritional behavioral counseling and will implement a daily 8-10-hour window within which they must consume their calories. They will also be required to log their caloric intake through the use of a smartphone app. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18-75 years
- 41 ≥ BMI ≥ 25 AND
- Metabolic syndrome, as defined as presence of 3 or more of the following criteria:
- Elevated fasting plasma glucose ≥ 100 mg/dL and/or HbA1c ≥ 5.7% < 7.1% Elevated waist circumference: In Asians: ≥ 90 cm in men, ≥ 80 cm in women, all other races: ≥ 102 cm in men, ≥ 88 cm in women Fasting plasma triglycerides ≥ 150 mg/dL, or on drug treatment for elevated triglycerides Reduced High-density lipoprotein (HDL)-cholesterol < 40 mg/dL in males or < 50 mg/dL in females, or drug treatment for reduced HDL-cholesterol Elevated blood pressure, Systolic blood pressure ≥ 135 mm Hg and/or diastolic blood pressure ≥ 85 mm Hg or drug treatment for hypertension
- Own a smartphone (Apple iOS or Android OS)
Key exclusion criteria (26 listed)
- Taking insulin within the last 6 months.
- Manifest diabetes, defined as HbA1c > 7.0% given a 0.3% margin of error in lab readings, or diagnosis of diabetes.
- Known inflammatory and/or rheumatologic disease.
- Active tobacco abuse or illicit drug use or history of treatment for alcohol abuse.
- Pregnant or breast-feeding women.
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 Eating + Standard of CareAlso: Time Restricted EatingParticipants in this arm will adhere to a daily, consistent 8-10-hr eating window for the course of the study as well as receive nutritional counseling from the study dietitian. | Behavioural | TRE + SOC |
| Standard of CareParticipants in this arm will receive nutritional counseling from the study dietician, but will not be required to adopt a 8-10-hr eating window. | Behavioural | SOC (Standard of Care) |
Primary outcome
Change in Glucose Levels Assessed Via HbA1c
Time frame: Baseline and 14 weeks
HbA1c (%)
Change in Glycemic Parameters Assessed Via Fasting Glucose
Time frame: Baseline and 14 weeks
Glycemic parameters assessed via fasting glucose (mg/dL)
Change in Glycemic Parameters Assessed Via HOMA-IR
Time frame: Baseline and 14 weeks
Glycemic parameters assessed via HOMA-IR (Homeostatic Model Assessment of Insulin Resistance) - a calculated index estimating insulin resistance from fasting blood glucose and insulin levels, using the formula (fasting glucose × fasting insulin) ÷ 405. Lower scores indicate healthier insulin sensitivity, while higher scores indicate greater insulin resistance.
Glycemic Parameters Assessed Via Fasting Insulin
Time frame: Baseline and 14 weeks
Glycemic parameters assessed via fasting insulin (μIU/mL)
Glycemic Parameters Assessed Via CGM Mean Glucose
Time frame: Baseline and 14 weeks
Glycemic parameters assessed via CGM mean glucose (mg/dL).
Glycemic Parameters Assessed Via CGM CONGA
Time frame: Baseline and 14 weeks
Glycemic parameters assessed via CGM CONGA (Continuous Overall Net Glycemic Action)
Glycemic Parameters Assessed Via CGM MODD
Time frame: Baseline and 14 weeks
Glycemic parameters assessed via CGM MODD (mg/dL)
6 secondary outcomes
Change in LDL Particle Number
Time frame: Baseline and 14 weeks
Change in LDL Cholesterol
Time frame: Baseline and 14 weeks
Change in HDL Cholesterol
Time frame: Baseline and 14 weeks
Change in Triglycerides
Time frame: Baseline and 14 weeks
Change in Body Composition by DXA
Time frame: Baseline and 14 weeks
Change in Hs-CRP
Time frame: Baseline and 14 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39348690Manoogian ENC, Wilkinson MJ, O'Neal M, Laing K, Nguyen J, Van D, Rosander A, Pazargadi A, Gutierrez NR, Fleischer JG, Golshan S, Panda S, Taub PR. Time-Restricted Eating in Adults With Metabolic Syndrome : A Randomized Controlled Trial. Ann Intern Med. 2024 Nov;177(11):1462-1470. doi: 10.7326/M24-0859. Epub 2024 Oct 1.
- Derived from this study: PubMed 35732151Taub PR, Panda S. Time for better time-restricted eating trials to lessen the burden of metabolic diseases. Cell Rep Med. 2022 Jun 21;3(6):100665. doi: 10.1016/j.xcrm.2022.100665.
- Individual participant dataSharing planned: Yes. Deidentified participant data used for findings in publication are available at https://data.mendeley.com. Any other data or material requests will be fulfilled at the discretion of Dr. Panda and Dr. Taub.
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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.
Pam Taub, MD principal investigator
Associate Professor of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Metabolic Syndrome and Pre-Diabetes, 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 7 inclusion and 26 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 30 Jul 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 30 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Glucose Levels Assessed Via HbA1c (time frame: Baseline and 14 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04057339, which also lists 2 linked publications.
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 30 Jul 2026.