Impact of Time-Restricted Eating on Metabolic and Neuroendocrine Homeostasis, Inflammation and Oxidative Stress in Metabolic Syndrome (TREMNIOS)
Metabolic Syndrome, Overweight or Obesity, PreDiabetes
About this trial
This is an interventional prevention trial for Metabolic Syndrome focused on measuring Time-Restricted Eating, Circadian Rhythm, Glucose Homeostasis, Fasting, Metabolic Syndrome, Overweight, Obesity, PreDiabetes, Weight Loss, Metabolic Homeostasis, Neuroendocrine Biomarkers, Inflammation, Oxidative Stress
Eligibility Criteria
Inclusion Criteria:
Metabolic syndrome, defined as the presence of elevated fasting plasma glucose ≥ 100 mg/dL and two or more of the following criteria:
Elevated waist circumference: ≥ 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 men, < 50 mg/dL in women (or drug treatment for reduced HDL-cholesterol); Elevated blood pressure, Systolic blood pressure ≥ 130 mm Hg and/or diastolic blood pressure ≥ 85 mm Hg (or drug treatment for hypertension).
- BMI > 25
- Duration of eating period ≥ 14 hours/day.
- Own a Smartphone with Apple Operating System (OS) or Android OS.
Exclusion Criteria:
- Diagnosis of diabetes.
- Pregnant or lactating women.
- Active smoking or illicit drug use or history of treatment for alcohol abuse.
- Shift work.
- Caregivers for dependent requiring nocturnal care.
- Planned travel over time zones during the study period.
- History of major adverse cardiovascular event within the past 1 year (acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass graft surgery, hospitalization for congestive heart failure, stroke/transient ischemic attack) or current uncontrolled arrhythmia.
- Uncontrolled medical conditions due to rheumatologic, hematologic, oncologic, infectious, gastrointestinal, psychiatric, nephrological, or endocrine diseases.
- Known history of an eating disorder.
- Currently enrolled in a weight-loss or weight-management program.
- Special or prescribed diet for other reasons (e.g. Celiac disease).
- Current treatment with antidepressants, medications affecting appetite, or immunosuppression.
- History of bariatric surgery.
- A score of > 16 on the Epworth Sleepiness Scale.
- Depression determined by the Beck Depression Inventory.
- Failure to use the smartphone app for documentation during a 2-week baseline period.
Sites / Locations
- Nicolaus Copernicus University, Collegium Medicum BydgoszczRecruiting
Arms of the Study
Arm 1
Experimental
Time-Restricted Eating