Efficacy and Feasibility of Time-restricted Eating on Cardiometabolic Health in Adults With Overweight/Obesity (EXTREME)
Time Restricted Feeding, Obesity, Abdominal, Cardiometabolic Syndrome
About this trial
This is an interventional treatment trial for Time Restricted Feeding
Eligibility Criteria
Inclusion Criteria:
- Aged 30-65 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.
- 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.
Sites / Locations
- Universidad Pública de Navarra
- University of Granada
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
No Intervention
Early time-restricted eating
Late time-restricted eating
Self-selected time-restricted eating
Usual-care group
Participants will eat ad libitum within an 8-hour early eating window. The first meal will be before 10 am (last meal before 18h). No calorie-containing food or beverage intake will be allowed outside the 8-hour eating window. Participants will also receive standard recommendations on healthy lifestyle based on Mediterranean dietary pattern and physical activity recommendations for weight loss and health promotion
Participants will eat ad libitum within an 8-hour late eating window. The first meal will be at 13h or later (last meal not before 21h). No calorie-containing food or beverage intake will be allowed outside the 8-hour eating window. Participants will also receive standard recommendations on healthy lifestyle based on Mediterranean dietary pattern and physical activity recommendations for weight loss and health promotion
Participants will self-selecte an 8-hour eating window to eat ad libitum. No calorie-containing food or beverage intake will be allowed outside the 8-hour eating window. Participants will also receive standard recommendations on healthy lifestyle based on Mediterranean dietary pattern and physical activity recommendations for weight loss and health promotion
Participants will receive standard recommendations on healthy lifestyle based on Mediterranean dietary pattern and physical activity recommendations for weight loss and health promotion