The Influence of Time-Restricted Eating in Patients With Metabolic Syndrome (TIMET)
Metabolic Syndrome, Pre-Diabetes
About this trial
This is an interventional treatment trial for Metabolic Syndrome focused on measuring Time Restricted Eating, Circadian Rhythm, Glucose Homeostasis, Mitochondrial Function, Fasting
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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).
Sites / Locations
- Altman Clinical and Translational Research Institute
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
SOC (Standard of Care)
TRE + SOC
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.
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.