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| Name | Class |
|---|---|
| Hospital Clinico Universitario San Cecilio | OTHER |
| University Hospital Virgen de las Nieves | OTHER |
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While body weight reduction can be achieved through various interventions in people living with obesity, most patients regain a substantial proportion of the lost weight within the following months. There is a lack of effective interventions to prevent this regain, making weight regain one of the most pressing challenges in obesity management. The goal of this clinical trial is to determine whether adhering to time-restricted eating (TRE; a form of intermittent fasting) during and after a dietary weight loss intervention, promotes weight maintenance to a greater extent than consuming all daily meals within 11 hours or more. Additionally, the study will address other questions, such as whether TRE improves body composition, insulin sensitivity, and cardiometabolic risk factors; whether the TRE intervention produces effects on different components of energy balance or related behaviors; and whether prior exposure to the TRE intervention influences eating window duration and weight change over the subsequent 24 months.
The study will compare participants who concentrate all their food intake within 8 hours or less with those who consume all their daily meals within 11 hours or more. All participants will follow a calorie-restricted diet designed to induce an 8-10% weight loss over 12-16 weeks and will be followed for several months after the weight loss intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Time-restricted eating (eating within 8 hours/day or less) | Experimental | Participants in the time-restricted eating group will be instructed to concentrate all daily meals to 8 hours or less |
|
| Regular eating window (eating within 11 hours/day or more) | Sham Comparator | Participants in the regular eating group will be instructed to spread all daily meals within a of 11 hours or more. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calorie restriction (Dietary intervention) | Behavioral | Calorie restriction intervention consisting on a meal plan designed to induce an 8-10% weight loss over a 12-16 week period. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in weight (Kg) during the 6 months following the end of the calorie restriction intervention | 6 after the end of the dietary intervention - End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss). |
| Measure | Description | Time Frame |
|---|---|---|
| Weight (Kg) | Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention | |
| Waist circumference (cm) | Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guillermo Sanchez-Delgado | Contact | +34 958241574 | gsanchezdelgado@ugr.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Physiology, Faculty of Medicine, University of Granada. | Recruiting | Granada | Granada | 18007 | Spain |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D000093763 | Intermittent Fasting |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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| Regular eating window | Behavioral | Receiving instructions to maintain their regular eating window (11h/d or more) both during the 12-16 weeks of calorie restriction and the 12 months following its completion. |
|
| Time-restricted eating | Behavioral | Receiving instructions to confine all daily meals to a period of 8 hours or less (at least 6 days a week) both during the 12-16 weeks of calorie restriction and the 12 months following its completion. |
|
| Hip Circumference (cm) | Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention. |
| Fat mass (kg) by DXA | Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention. |
| Fat free mass (kg) by DXA | Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention. |
| Fat mass (kg) by Bioimpendaciometry | Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention. |
| Fat free mass (kg) by Bioimpendaciometry | Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention. |
| Body Mass Index (kg/m2) | Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention. |
| Resting Energy Expenditure (kcal/day) measured by indirect calorimetry | Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention. |
| Posprandial Energy Expenditure (kcal/day) measured by indirect calorimetry | Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 6 months after the end of dietary intervention. |
| Fasting nutrient utilization rates (g/min) measured by indirect calorimetry and protein excretion | Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention. |
| Postprandial nutrient utilization rates (g/min) measured by indirect calorimetry and protein excretion | Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 6 months after the end of dietary intervention. |
| Energy Intake (kcal) in an Ad-Libitum Meal Test | Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 6 months after the end of dietary intervention. |
| Energy efficiency (W/KJ) while cycling, assessed by indirect calorimetry | Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 6 months after the end of dietary intervention. |
| Maximal fat oxidation (g/min) by indirect calorimetry | Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention. |
| Physical activity (counts/day) measured by accelerometry | Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 6 after the end of dietary intervention. |
| Sedentary time (min/day) measured by accelerometry | Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 6 months after the end of dietary intervention |
| Habitual food consumption collected by a food frecuency questionnaire | Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 6 months after the end of dietary intervention. |
| Serum Total Cholesterol (mg/dl) | Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention. |
| Serum LDL cholesterol (mg/dl) | Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention. |
| Serum HDL cholesterol (mg/dl) | Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention. |
| Serum triglycerides (mg/dl) | Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention. |
| Serum glucose (mg/dl) | Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention. |
| Serum insulin (U/ml) | Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention. |
| Serum hemoglobin A1c (mmol/mol) | Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention. |
| Serum thyrotropin (µU/mL) | Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention. |
| Serum Alanine Transaminase (U/L) | Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention |
| Serum Aspartate Transaminase (U/L) | Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention. |
| Serum gamma-glutamyl transferase (U/L) | Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention. |
| Serum C-reactive protein (mg/dL) | Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention. |
| Craving Control measured using the Control of Eating Weekly Questionnaire (CoEQ) | Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention. |
| Positive Mood measured using the Control of Eating Weekly Questionnaire (CoEQ) | Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention. |
| Craving for Sweet Foods measured using the Control of Eating Weekly Questionnaire (CoEQ) | Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention. |
| Craving for Savory Foods measured using the Control of Eating Weekly Questionnaire (CoEQ) | Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention. |
| Fasting appetite-related sensations measured using "Visual Analogue Scales (VAS)" | Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention. |
| Meal-induced changes in appetite-related sensations measured using "Visual Analogue Scales (VAS)" in response to a meal | Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 6 months after the end of dietary intervention. |
| Fasting Liking and Wanting measured using Leeds Food Preference Questionnaire | Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention. |
| Liking and Wanting in response to a meal measured using Leeds Food Preference Questionnaire | Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 6 months after the end of dietary intervention. |
| Meal-induced changes in serum glucose concentration (mg/dL) in response to a standardized meal | Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 6 months after the end of dietary intervention. |
| Meal-induced changes in serum insulin concentration (U/ml) in response to a standardized meal | Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 6 months after the end of dietary intervention. |
| Cognitive restriction of food intake measured using the "Three-Factor Eating Questionnaire" | Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 6 months after the end of dietary intervention. |
| Food disinhibition measured using the "Three-Factor Eating Questionnaire" | Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 6 months after the end of dietary intervention. |
| Subjective hunger measured using the "Three-Factor Eating Questionnaire" | Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention. |
| Binge eating behavior measured using the "Binge Eating Questionnaire" | Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 6 months after the end of dietary intervention. |
| Sleep time (min) measured by accelerometry | Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 6 months after the end of dietary intervention. |
| Handgrip strength (kg) measured using a dynamometer | Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 6 months after the end of dietary intervention. |
| Functional mobility measured by "Timed Up and Go (TUG)" test | Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 6 months after the end of dietary intervention. |
| Walking speed (m/s) measured by a gait speed test | Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 6 months after the end of dietary intervention. |
| Independence in activities of daily living (ADL) measured by "Barthel Index" | Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 6 months after the end of dietary intervention |
| Food cravings measured using the "Food Craving Inventory" questionnaire | Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 6 months after the end of dietary intervention |
| Carbohydrate intake (g/day) collected through three 24-hour recalls | Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention. |
| Fat intake (g/day) collected through three 24-hour recalls | Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention. |
| Protein intake (g/day) collected through three 24-hour recalls | Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention. |
| Fiber intake (g/day) collected through three 24-hour recalls | Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention. |
| Changes in appetite-related sensations measured using "Visual Analogue Scales (VAS)" in response to a submaximal stress test | Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 6 months after the end of dietary intervention. |
| Resting heart rate variability | Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention. |
| Resting Systolic blood pressure (mmHg) | Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention. |
| Resting Diastolic blood pressure (mmHg) | Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D001836 | Body Weight Changes |