Status:
COMPLETED
Efficacy and Feasibility of Time-restricted Eating on Cardiometabolic Health in Adults With Overweight/Obesity
Lead Sponsor:
Universidad de Granada
Collaborating Sponsors:
Universidad Pública de Navarra
Conditions:
Time Restricted Feeding
Obesity, Abdominal
Eligibility:
All Genders
30-60 years
Phase:
NA
Brief Summary
In Spain, obesity epidemic is one of the leading contributors of chronic disease and disability. Obesity is associated with higher morbidity and all-cause mortality risk especially when fat is stored ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 6 2023
Estimated Enrollment :
197 Patients enrolled
Trial Details
Trial ID
NCT05310721
Start Date
April 11 2022
End Date
March 6 2023
Last Update
November 29 2023
Active Locations (2)
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1
Universidad Pública de Navarra
Pamplona, Navarre, Spain, 31006
2
University of Granada
Granada, Spain, 18011