None listed
Conditions
Brief summary
The early time-restricted eating (eTRE) is a regimen that reduces the eating window and facilitates a longer overnight fast which may contribute to improve metabolic control. However, there is not a consensus about this topic and the implicated mechanism in this process is unknown. Therefore, we aimed to evaluate the effect of eTRE on metabolic control and circadian rhythm markers in subjects with obesity. Every participant will undergo two phases of treatment for 4 weeks each. Each phase will be separated by a 6-week washout period. The meal tolerance test, the evaluation of appetite and the circadian rhythm gene expression analyses will be carried out one day before and one day after the interventions. The control intervention will consist of a period of 12 hours of feeding and 12 hours of fasting, while the eTRE intervention will consist of 8 hours of food intake and 16 hours of fasting. We hypothesised that eTRE will improve metabolic control and circadian rhythm markers in subjects with obesity.
Interventions
In a randomised, controlled, and crossover design, thirty participants will be randomised into one of the two intervention phases: control arm or early time-restricted eating (eTRE) arm for four weeks. Each phase will be separated by six weeks washout period. The eTRE arm will consist of an 8-hour feeding window (07:00 to 15:00) and 16-hour of fasting period. Meanwhile, the control arm will consist of a 12-hour feeding window (07:00 to 19:00) and 12-hour of fasting period. Participants will log
In a randomised, controlled, and crossover design, thirty participants will be randomised into one of the two intervention phases: control arm or early time-restricted eating (eTRE) arm for four weeks. Each phase will be separated by six weeks washout period. The eTRE arm will consist of an 8-hour feeding window (07:00 to 15:00) and 16-hour of fasting period. Meanwhile, the control arm will consist of a 12-hour feeding window (07:00 to 19:00) and 12-hour of fasting period. Participants will log in a food diary the food and the start and stop time of every meal eaten two weeks before the first phase of intervention and during each intervention phase. Before and after each intervention phase and during a 4-hour visit to the study clinic, the following parameters will be determined: body weight, waist/hip circumference, biochemical parameters, and blood pressure by a healthcare provider. Meal Tolerance Test (MTT) will be performed for glycaemic and insulinemic response and subjective appetite. The standardized breakfast for the MTT, will consist of a commercial standardized liquid meal and a Kellog’s® Rice Krispies® bar both providing 210 calories, 79% carbohydrates, 14% protein and 7% fat. To assess patient's adherence subjects will be regularly monitored by WhatsApp and phone calls..
Sponsors
Universidad Juárez Autónoma de Tabasco
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 59 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 18-59. Both men and women. 2. Body Mass Index (BMI) >30 kg/m2. 3. Have maintained stable weight during three months prior to intervention. 4. Regular menstrual cycle (for women). 5. Independently provide informed consent .
Exclusion criteria
1. Diagnosis of diabetes, cardiovascular, kidney, liver, gastrointestinal, psychiatric or endocrine disease. 2. Pregnant or breast-feeding females. 3. Have diagnostic of sleeping disorders. 4. History of gastrointestinal surgery. 5. Nightshift work more than once a week. 6. Consumption of corticosterois and ß-blockers. 7. Fasting regularly more than 15 hours/day. 8. Nicotine or tobacco consumption. 9. Alcohol consumption. 10. Regular participation in sports training or intense physical activity.
Outcome results
None listed