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This study investigates the effect and feasibility of time-restricted eating (eating within a set window of hours) on cardiometabolic health in adults who are overweight or obese. It enrolled sedentary adults aged 30-60 with a body mass index between 25 and 40. This is a study without a phase and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria:
* Aged 30-60 years.
* Body mass index ≥25.0 and \<40 kg/m2
* Weight stability (within 3% of screening weight) for \>3 months prior to study entry.
* Sedentary lifestyle (\<150 min/week of moderate-vigorous intensity exercise) for \>3 months prior to study entry.
* Habitual eating window ≥12 hours.
* At least one of the following metabolic impairments:
* High-density lipoprotein (HDL) cholesterol concentration \<50 mg/dL for females and \<40 mg/dL for males.
* Low-density lipoprotein (LDL) cholesterol levels \>100 mg/dL (or on medication to treat elevated LDL cholesterol levels).
* Serum triglycerides concentration ≥150 mg/dL or on medication to treat elevated triglycerides.
* Systolic blood pressure \>130 mm Hg and/or diastolic blood pressure \>85 mm Hg or already being treated with anti-hypertension medications.
* Impaired glucose tolerance is defined as at least one of the following:
* Fasting plasma glucose (PG) \>100 mg/dL and \<125 mg/dL.
* Hemoglobin A1c between ≥5.7% and \<6.5%.
* Insulin resistance as measured by the Homeostatic Model Assessment of Insulin Resistance (HOMA2-IR) \>1.8.
Exclusion Criteria:
* History of a major adverse cardiovascular event, clinically significant kidney, endocrine, or neurological disease, bariatric surgery, HIV/AIDS, known inflammatory and/or rheumatologic disease, cancer, or other medical condition in which fasting or exercise is contraindicated.
* Type 1 or Type 2 diabetes.
* Major psychiatric disorders, eating disorders, sleep disorders, or alcohol abuse.
Regular use of medication or compounds that may affect study outcomes (e.g., antidiabetic, steroids, beta-blockers, antibiotics, prebiotics, probiotics and symbiotics).
* Participating in a weight loss or a weight-management program.
* Pregnancy and lactation or planned pregnancy (within the study period).
* Caregiver for a dependent requiring frequent nocturnal care/sleep interruptions. Shift workers with variable hours (e.g., nocturnal). Frequent travel over time zones during the study period.
* Fear of needles and claustrophobia to magnetic resonance imaging (MRI).
* Being unable to understand and to accept the instructions or the study objectives and protocol.