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Time-restricted eating (TRE) is a dietary approach that aims to increase fasting time and decrease the eating window. Promising TRE effects on weight loss and improvements in some cardiometabolic risk factors have been reported in studies in animals and humans. However, the impacts of TRE combined with aerobic exercise training in individuals with overweight and obesity have been insufficiently investigated.
Additionally, aerobic training performed in a fasted state appears to promote physiological adaptations that may improve the metabolic health in individuals with overweight and obesity.
The present study investigates the effects of 8 weeks of TRE associated with aerobic training in a fasted state versus a fed state on body composition and cardiometabolic parameters in women with overweight and grade 1 obesity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Time-Restricted Eating and Aerobic Exercise Performed in Fasted State | Experimental | Participants will be prescribed a diet plan to promote weight loss, but no food will be provided to them. Diets will be formulated to contain 50% energy as carbohydrate, 20% as protein, and 30 % as fat. Participants will be instructed to divide their daily energy intake between three meals each day (lunch, afternoon snack, and dinner). Participants will be instructed to eat from 12.00 until 20.00 (8-hour window). Aerobic exercise sessions will be carried out during the morning shift with participants in a fasted state. |
|
| Time-Restricted Eating and Aerobic Exercise Performed in Fed State | Active Comparator | Participants will be prescribed a diet plan to promote weight loss, but no food will be provided to them. Diets will be formulated to contain 50% energy as carbohydrate, 20% as protein, and 30 % as fat. Participants will be instructed to divide their daily energy intake between three meals each day (lunch, afternoon snack, and dinner). Participants will be instructed to eat from 12.00 until 20.00 (8-hour window). Aerobic exercise sessions will be carried out during the afternoon shift with participants in a fed state. |
|
| Time-Restricted Eating | Other | Participants will be prescribed a diet plan to promote weight loss, but no food will be provided to them. Diets will be formulated to contain 50% energy as carbohydrate, 20% as protein, and 30 % as fat. Participants will be instructed to divide their daily energy intake between three meals each day (lunch, afternoon snack, and dinner). Participants will be instructed to eat from 12.00 until 20.00 (8-hour window). Participants in this arm will not perform aerobic exercise training. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary and Exercise Approaches | Behavioral | Intermittent fasting plus energy restriction combined with aerobic exercise performed in a fasted state. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Insulin sensitivity (indices) | Including but not limited to the Sensitivity Matsuda index | Change from baseline. Measured at baseline and after 8 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin resistance (indices) | Including but not limited to Homeostatic Model Assessment for Insulin Resistance (HOMA-IR). | Change from baseline. Measured at baseline and after 8 weeks. |
| Fasting insulin levels (µIU/mL) |
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Inclusion Criteria:
Exclusion Criteria:
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| Dietary and Exercise Approaches | Behavioral | Intermittent fasting plus energy restriction combined with aerobic exercise performed in a fed state. |
|
| Dietary Approach | Behavioral | Intermittent fasting plus energy restriction without aerobic exercise training. |
|
Measured by enzyme-Linked Immunosorbent Assay
| Change from baseline. Measured at baseline and after 8 weeks. |
| Fasting glucose levels (mg/dL) | Measured by colorimetric method | Change from baseline. Measured at baseline and after 8 weeks. |
| Glucose tolerance | Measured by oral glucose tolerance test (2-h OGTT) | Change from baseline. Measured at baseline and after 8 weeks. |
| Fasting lipid profile levels | Measured by colorimetric method | Change from baseline. Measured at baseline and after 8 weeks. |
| β cell function (indices) | Including but not limited to HOMA-β | Change from baseline. Measured at baseline and after 8 weeks. |
| Fat Mass (kg) | Measured by Dual-energy X-ray Absorptiometry under fasting condition. | Change from baseline. Measured at baseline and after 8 weeks. |
| Fat Percentage (%) | Measured by Dual-energy X-ray Absorptiometry under fasting condition. | Change from baseline. Measured at baseline and after 8 weeks. |
| Fat Free Mass (kg) | Measured by Dual-energy X-ray Absorptiometry under fasting condition. | Change from baseline. Measured at baseline and after 8 weeks. |
| Body Weight (kg) | Measured by Dual-energy X-ray Absorptiometry under fasting condition. | Change from baseline. Measured at baseline and after 8 weeks. |
| Body Weight (kg) | Measured on a digital scale. | Change from baseline. Measured at baseline and after 4, and 8 weeks. |
| Bone Mineral Content (kg) | Measured by Dual-energy X-ray Absorptiometry under fasting condition. | Change from baseline. Measured at baseline and after 8 weeks. |
| Body Mass Index (kg/m^2) | Calculated from weight in kilograms divided by height in meters squared. | Change from baseline. Measured at baseline and after 8 weeks. |
| Fasting ketones (β-hydroxybutyrate) levels (mmol/L) | Change from baseline. Measured at baseline and after 8 weeks. |
| Resting metabolic rate (Kcal/day) | Measured by indirect calorimetry under resting and fasting conditions. | Change from baseline. Measured at baseline and after 8 weeks. |
| Substrate Oxidation (respiratory exchange ratio) | Measured by indirect calorimetry under resting and fasting conditions. | Change from baseline. Measured at baseline and after 8 weeks. |
| Absolute Peak oxygen consumption | Measured by an open-circuit spirometry system. Absolute value expressed in litres of oxygen per minute (L/min). | Change from baseline. Measured at baseline and after 4, and 8 weeks. |
| Relative Peak oxygen consumption | Measured by an open-circuit spirometry system. Relative to body weight and expressed in milliliters of oxygen per minute (mL/kg/min). | Change from baseline. Measured at baseline and after 4, and 8 weeks. |
| Fasting Leptin Levels | Measured by enzyme-Linked Immunosorbent Assay | Change from baseline. Measured at baseline and after 8 weeks. |
| Fasting Adiponectin Levels | Measured by enzyme-Linked Immunosorbent Assay | Change from baseline. Measured at baseline and after 8 weeks. |
| Inflammatory Markers Levels | Including but not limited to TNF-α (tumor necrosis factor-alpha) and IL-10 (Interleukin-10); Measured by enzyme-Linked Immunosorbent Assay | Change from baseline. Measured at baseline and after 8 weeks. |
| LDL-cholesterol levels | Measured using the Friedewald equation. | Change from baseline. Measured at baseline and after 8 weeks. |
| Non-HDL-cholesterol levels | Calculated as total cholesterol minus HDL-cholesterol. | Change from baseline. Measured at baseline and after 8 weeks. |
| ID | Term |
|---|---|
| D000093763 | Intermittent Fasting |
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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