Active, not recruitingNot applicableInterventional
What this study is about
In a randomized controlled trial, the investigators intend to measure the health impact of time-restricted eating (TRE) in obese patients (body mass index (BMI) ≥ 30 kg/m2), who habitually eat for more than 14 hours every day. Patients will be randomly assigned to a control group of behavioral nutritional counseling (standard of care) or the intervention group of behavioral nutrition counseling with the addition of adopting a 10-hour eating window for 12 weeks (TRE).
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionObesity
Full registry criteria
Inclusion Criteria: 1. Age: ≥ 18 years old 2. BMI 30-50 kg/m2 3. Own a smartphone with Apple iOS or Android OS 4. Baseline eating window ≥ 14 hours/day 5. 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 drugs, no dose adjustments will be allowed during the study period. Exclusion Criteria: 1. Taking insulin or anti-diabetic medications within the last 6 months. 2. Manifest diabetes, defined as fasting glucose ≥ 126 mg/dL, HbA1c ≥ 6.5%, or diagnosis of diabetes. 3. Currently taking any medication that is meant for, or has known effect on, appetite or body weight 4. Pregnant or breast-feeding women. 5. Caregiver for a dependent requiring frequent nocturnal care/sleep interruptions. Shift workers with variable (e.g. nocturnal) hours. 6. Planned international travel (time zone changes) during study period. 7. Taking therapeutic anticoagulation which might increase risk of bleeding from adipose tissue biopsy 8. History of surgical intervention for weight loss. 9. History of eating disorder 10. Currently enrolled in a weight-loss or weight-management program 11. On a special or prescribed diet for other reasons (e.g. Celiac disease) 12. Known inflammatory and/or rheumatologic disease 13. Active tobacco abuse or illicit drug use or history of treatment for alcohol abuse 14. History of bone marrow or solid organ transplant 15. History of heart failure 16. History of major adverse cardiovascular events (acute coronary syndrome (ACS), percutaneous coronary intervention, coronary artery bypass graft surgery, stroke/transient ischemic attack (TIA)). 17. History of atrial fibrillation or atrial flutter 18. History of malignancy, other than non-melanoma skin cancer, that is currently being treated, or that has not been treated with definitive therapy and considered to be in remission. 19. History of hypo- or hyperthyroidism 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) 20. History of adrenal disease 21. History of cirrhosis 22. History of stage 4 or 5 chronic kidney disease or requiring dialysis 23. History of HIV/AIDS 24. Uncontrolled psychiatric disorder (including history of hospitalization for psychiatric illness). 25. History of obstructive sleep apnea (not on stable positive pressure therapy or other treatment for at least 3 months prior to enrollment) 26. Abnormal screening labs: renal dysfunction (eGFR \< 30 ml/min/1.73 m2), anemia, hypo- or hyperthyroidism, coagulopathy, abnormal liver function (AST, ALT \> 3x upper limit of normal)
