The Influence of Time-Restricted Eating in Patients With Metabolic Syndrome (TIMET)

This is an interventional treatment trial for Metabolic Syndrome focused on measuring Time Restricted Eating, Circadian Rhythm, Glucose Homeostasis, Mitochondrial Function, Fasting Read More

Inclusion Criteria:

1. Age 18-75 years
2. 41 ≥ BMI ≥ 25 AND

3. 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

4. Own a smartphone (Apple iOS or Android OS)
5. Baseline eating period ≥ 12 hour window
6. 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.

Exclusion Criteria:

1. Taking insulin within the last 6 months.
2. Manifest diabetes, defined as HbA1c > 7.0% given a 0.3% margin of error in lab readings, or diagnosis of diabetes.
3. Known inflammatory and/or rheumatologic disease.
4. Active tobacco abuse or illicit drug use or history of treatment for alcohol abuse.
5. Pregnant or breast-feeding women.
6. Shift workers with variable (e.g. nocturnal) hours.
7. Caregivers for dependent requiring frequent nocturnal care/sleep interruptions.
8. Planned travel to a time zone with greater than a 3-hour difference during study period.
9. 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)).
10. Uncontrolled arrhythmia (i.e. rate-controlled atrial fibrillation/atrial flutter are not exclusion criteria).
11. 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).
12. History of adrenal disease.
13. History of malignancy undergoing active treatment, except non-melanoma skin cancer.
14. Known history of type I diabetes.
15. History of eating disorder(s).
16. History of cirrhosis.
17. History of stage 4 or 5 chronic kidney disease or requiring dialysis.
18. History of HIV/AIDS.
19. Currently enrolled in a weight-loss or weight-management program.
20. On a special or prescribed diet for other reasons (e.g. Celiac disease).
21. Currently taking any medication that is meant for, or has known effect on, appetite.
22. Any history of surgical intervention for weight management.
23. Uncontrolled psychiatric disorder (including history of hospitalization for psychiatric illness).
24. A score of >16 on the Epworth Sleepiness Scale (ESS).
25. Depression determined by the Beck Depression Inventory (BDI) (unless previously diagnosed and well-controlled).
26. Failure to use the smartphone app for documentation (defined as <2 meals/day for ≥3 days during baseline).