An interventional study of Time Restricted Eating + Standard of Care and Standard of Care in Metabolic Syndrome and Pre-Diabetes, sponsored by University of California, San Diego. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by University of California, San Diego · Not applicable, Interventional, and Treatment
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).
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.
2,116 studies on the registry are indexed under Metabolic Syndrome; 347 are open to participants now.
This study's enrollment of 122 is above the median of 60 across 1,572 interventional studies indexed under Metabolic Syndrome.
Browse Metabolic Syndrome studies →University of California, San Diego is the lead sponsor of 980 studies on the registry; 195 are open to participants now.
Of its 113 completed or terminated interventional studies of FDA-regulated products, 71 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Metabolic syndrome, as defined as presence of 3 or more of the following criteria:
Elevated fasting plasma glucose ≥ 100 mg/dL and/or ≥ 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
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Standard of Care
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.
Behavioral: Time Restricted Eating + Standard of Care
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.
Also known as: Time Restricted Eating
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.
Change in Glucose Levels Assessed Via HbA1c
HbA1c (%)
Time frame: Baseline and 14 weeks
Change in Glycemic Parameters Assessed Via Fasting Glucose
Glycemic parameters assessed via fasting glucose (mg/dL)
Time frame: 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.
Time frame: Baseline and 14 weeks
Glycemic Parameters Assessed Via Fasting Insulin
Glycemic parameters assessed via fasting insulin (μIU/mL)
Time frame: Baseline and 14 weeks
Glycemic Parameters Assessed Via CGM Mean Glucose
Glycemic parameters assessed via CGM mean glucose (mg/dL).
Time frame: Baseline and 14 weeks
Glycemic Parameters Assessed Via CGM CONGA
Glycemic parameters assessed via CGM CONGA (Continuous Overall Net Glycemic Action)
Time frame: Baseline and 14 weeks
Glycemic Parameters Assessed Via CGM MODD
Glycemic parameters assessed via CGM MODD (mg/dL)
Time frame: Baseline and 14 weeks
Change in LDL Particle Number
LDL particle number (nmol/L) via NMR lipoprofile
Time frame: Baseline and 14 weeks
Change in LDL Cholesterol
LDL cholesterol (mg/dl)
Time frame: Baseline and 14 weeks
Change in HDL Cholesterol
HDL cholesterol (mg/dl)
Time frame: Baseline and 14 weeks
Change in Triglycerides
Triglycerides (mg/dl)
Time frame: Baseline and 14 weeks
Change in Body Composition by DXA
Lower abdominal fat mass as assessed by dual-energy X-ray absorptiometry (DXA).
Time frame: Baseline and 14 weeks
Change in Hs-CRP
High sensitivity C-reactive protein (mg/L)
Time frame: Baseline and 14 weeks
Change in Mitochondrial Structure and Gene Expression in Skeletal Muscle
Mitochondrial structure and gene expression in skeletal muscle as assessed by skeletal muscle biopsies.
Time frame: Baseline and 14 weeks
| Milestone | SOC (Standard of Care) | TRE + SOC |
|---|---|---|
| Started | 61 | 61 |
| Completed | 54 | 54 |
| Not completed | 7 | 7 |
HbA1c (%)
| percentage of HbA1c | TRE + SOC | SOC (Standard of Care) |
|---|---|---|
| Change in Glucose Levels Assessed Via HbA1c | -0.12 (-0.19 to -0.05) | -0.02 (-0.09 to 0.04) |
Glycemic parameters assessed via fasting glucose (mg/dL)
| mg/dL | TRE + SOC | SOC (Standard of Care) |
|---|---|---|
| Change in Glycemic Parameters Assessed Via Fasting Glucose | -4.83 (-7.48 to -2.19) | -1.50 (-4.54 to 1.54) |
LDL particle number (nmol/L) via NMR lipoprofile
| nmol/L | TRE + SOC | SOC (Standard of Care) |
|---|---|---|
| Change in LDL Particle Number | -125.46 (-191.90 to -59.03) | -48.00 (-104.64 to 8.64) |
LDL cholesterol (mg/dl)
| mg/dl | TRE + SOC | SOC (Standard of Care) |
|---|---|---|
| Change in LDL Cholesterol | -10.48 (-15.83 to -5.13) | -1.37 (-6.38 to 3.64) |
HDL cholesterol (mg/dl)
| mg/dl | TRE + SOC | SOC (Standard of Care) |
|---|---|---|
| Change in HDL Cholesterol | -1.37 (-2.90 to 0.15) | -0.37 (-1.98 to 1.24) |
Triglycerides (mg/dl)
| mg/dl | TRE + SOC | SOC (Standard of Care) |
|---|---|---|
| Change in Triglycerides | -7.78 (-19.78 to 4.23) | -13.94 (-26.17 to -1.82) |
Lower abdominal fat mass as assessed by dual-energy X-ray absorptiometry (DXA).
| percentage of fat | TRE + SOC | SOC (Standard of Care) |
|---|---|---|
| Change in Body Composition by DXA | -1.55 (-7.87 to -0.90) | -0.15 (-0.83 to 0.53) |
High sensitivity C-reactive protein (mg/L)
| mg/L | TRE + SOC | SOC (Standard of Care) |
|---|---|---|
| Change in Hs-CRP | -0.19 (-0.66 to 0.28) | -0.09 (-0.89 to 0.71) |
Mitochondrial structure and gene expression in skeletal muscle as assessed by skeletal muscle biopsies.
Results for this outcome have not been posted.
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.
| Index | TRE + SOC | SOC (Standard of Care) |
|---|---|---|
| Change in Glycemic Parameters Assessed Via HOMA-IR | -0.89 (-1.93 to 0.05) | -0.38 (-1.07 to 0.31) |
Glycemic parameters assessed via fasting insulin (μIU/mL)
| μIU/mL | TRE + SOC | SOC (Standard of Care) |
|---|---|---|
| Glycemic Parameters Assessed Via Fasting Insulin | -2.88 (-6.39 to 0.64) | -1.21 (-3.47 to 1.06) |
Glycemic parameters assessed via CGM mean glucose (mg/dL).
| mg/dL | TRE + SOC | SOC (Standard of Care) |
|---|---|---|
| Glycemic Parameters Assessed Via CGM Mean Glucose | -2.26 (-5.27 to 0.75) | 1.98 (-1.33 to 5.30) |
Glycemic parameters assessed via CGM CONGA (Continuous Overall Net Glycemic Action)
| mg/dL | TRE + SOC | SOC (Standard of Care) |
|---|---|---|
| Glycemic Parameters Assessed Via CGM CONGA | -1.47 (-2.53 to -0.41) | 0.06 (-0.99 to 1.11) |
Glycemic parameters assessed via CGM MODD (mg/dL)
| mg/dL | TRE + SOC | SOC (Standard of Care) |
|---|---|---|
| Glycemic Parameters Assessed Via CGM MODD | -1.89 (-2.89 to 0.88) | 0.53 (-0.58 to 1.64) |
Collected over 14 weeks. Non-serious events are listed at a 1.6% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SOC (Standard of Care) | 0/61 (0%) | 0/61 (0%) | 0/61 (0%) |
| TRE + SOC | 0/61 (0%) | 0/61 (0%) | 1/61 (1.6%) |
| Event | SOC (Standard of Care) | TRE + SOC |
|---|---|---|
| Irritability and FatigueGeneral disorders | 0/61 | 1/61 |
| Age, Continuous(years) | SOC (Standard of Care) | TRE + SOC | Total |
|---|---|---|---|
| Mean | 61.43 ± 9.17 | 56.78 ± 11.34 | 58.74 ± 10.94 |
| Sex: Female, Male(Participants) | SOC (Standard of Care) | TRE + SOC | Total |
|---|---|---|---|
| Female | 31 | 31 | 62 |
| Male | 30 | 30 | 60 |
| Ethnicity (NIH/OMB)(Participants) | SOC (Standard of Care) | TRE + SOC | Total |
|---|---|---|---|
| Hispanic or Latino | 5 | 3 | 8 |
| Not Hispanic or Latino | 56 | 56 | 112 |
| Unknown or Not Reported | 0 | 2 | 2 |
| Race (NIH/OMB)(Participants) | SOC (Standard of Care) | TRE + SOC | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 16 | 10 | 26 |
| Native Hawaiian or Other Pacific Islander | 0 | 2 | 2 |
| Black or African American | 2 | 7 | 9 |
| White | 38 | 36 | 74 |
| More than one race | 5 | 4 | 9 |
| Unknown or Not Reported | 0 | 2 | 2 |
| Region of Enrollment(Participants) | SOC (Standard of Care) | TRE + SOC | Total |
|---|---|---|---|
| United States | 61 | 61 | 122 |
| Medications for treatment of metabolic syndrome(participants) | SOC (Standard of Care) | TRE + SOC | Total |
|---|---|---|---|
| Metformin | 3 | 4 | 7 |
| Statins | 31 | 29 | 60 |
| Antihypertensives and diuretics | 31 | 28 | 59 |
| Nonstatin lipid-lowering drugs | 2 | 2 | 4 |
| 1 or more medication listed | 38 | 46 | 84 |
| Metabolic syndrome classification(participants) | SOC (Standard of Care) | TRE + SOC | Total |
|---|---|---|---|
| HbA1c≥5.7 %, fasting glucose ≥5.55 mmol/L (100 mg/dL), or drug treatment | 61 | 61 | 122 |
| HDL cholesterol: M <40 mg/dL or F < 50 mg/dL (F), or drug treatment of reduced HDL cholesterol | 42 | 44 | 86 |
| Triglycerides ≥1.69 mmol/L (150 mg/dL), or drug treatment of elevated triglycerides | 25 | 25 | 50 |
| SBP ≥130 mm Hg and/or DBP ≥85 mm Hg, or drug treatment of hypertension | 44 | 48 | 92 |
| Waist circumference: Asian: ≥90 cm (M) or ≥80 cm (F); all other races: ≥102 cm (M) or ≥88 cm (F) | 55 | 52 | 107 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Study protocol and statistical analysis plan were published along with the initial publication.
Access criteria: Information on all IPD can be accessed through the initial publication.
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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