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| ID | Type | Description | Link |
|---|---|---|---|
| PID2021-127582OA-I00 | Other Identifier | University of Granada |
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| Name | Class |
|---|---|
| Hospital Clinico Universitario San Cecilio | OTHER |
| University Hospital Virgen de las Nieves | OTHER |
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The BATON study investigates how human brown adipose tissue (BAT) adapts to a controlled caloric restriction diet in young adults with obesity. A weight maintenance diet group will be compared to a group following a diet designed to induce an 8-10% weight loss over a 12-16 week period. Outcome assessments will include advanced technologies such as PET-CT and molecular analyses of BAT. The overarching goal is to gain a deeper understanding of the role of human BAT on the regulation of body weight.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Weight loss group | Experimental |
| |
| Control group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caloric restriction diet | Behavioral | Dietary intervention consisting on a meal plan designed to induce an 8-10% weight loss over a 12-16 week period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| BAT volume | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss). | |
| BAT 18F-FDG uptake upon cold exposure | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss). | |
| BAT UCP-1 protein content | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss). | |
| Mean adipocyte size | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss). |
| Measure | Description | Time Frame |
|---|---|---|
| BAT transcriptomics (RNA sequencing) | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss). | |
| Weight (kg) | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss); 6 months after the end of dietary intervention; 12 months after the end of dietary intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guillermo Sanchez Delgado, Ramon y Cajal Researcher | Universidad de Granada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Physiology, Faculty of Medicine, University of Granada. | Granada | Granada | 18007 | Spain |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D031204 | Caloric Restriction |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D002149 | Energy Intake |
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| Weight maintenance diet | Behavioral | Dietary intervention consisting on a meal plan designed to maintain a stable body weight for up to 16 weeks. |
|
| Waist circumference (cm) | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss); 6 months after the end of dietary intervention; 12 months after the end of dietary intervention |
| Hip circumference (cm) | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss); 6 months after the end of dietary intervention; 12 months after the end of dietary intervention |
| Resting Systolic blood pressure (mmHg) | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss); 6 months after the end of dietary intervention; 12 months after the end of dietary intervention |
| Resting Diastolic blood pressure (mmHg) | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss); 6 months after the end of dietary intervention; 12 months after the end of dietary intervention |
| Fat mass (kg) by DXA | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss); 6 months after the end of dietary intervention; 12 months after the end of dietary intervention |
| Fat free mass (kg) by DXA | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss); 6 months after the end of dietary intervention; 12 months after the end of dietary intervention |
| Fat mass (kg) by Bioimpedanciometry | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss); 6 months after the end of dietary intervention; 12 months after the end of dietary intervention |
| Fat free mass (kg) by Bioimpedanciometry | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss); 6 months after the end of dietary intervention; 12 months after the end of dietary intervention |
| Body Mass Index (kg/m2) | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss); 6 months after the end of dietary intervention; 12 months after the end of dietary intervention |
| Resting Energy Expenditure (kcal/day) measured by indirect calorimetry | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss); 6 months after the end of dietary intervention; 12 months after the end of dietary intervention |
| Ad libitum energy intake (kcal) measured in a test meal | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss). |
| Meal-induced thermogenesis (% of resting energy expenditure) measured by indirect calorimetry | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss). |
| Resting heart rate variability | RMSSD, SDNN | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss). |
| Maximal fat oxidation (g/min) by indirect calorimetry | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss). |
| Physical activity (counts) measured by accelerometry | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss). |
| Sedentary time (min) measured by accelerometry | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss). |
| Habitual food consumption collected by a food frequency questionnaire | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss); 6 months after the end of dietary intervention; 12 months after the end of dietary intervention |
| Serum total cholesterol (mg/dl) | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss). |
| Serum C-reactive protein (mg/l) | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss). |
| Serum thyrotropin (µU/mL) | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss). |
| Serum alanine aminotransferase (U/L) | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss). |
| Serum aspartate aminotransferase (U/L) | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss). |
| Serum gamma-glutamyl transferase (U/L) | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss). |
| Serum triglycerides (mg/dl) | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss). |
| Serum LDL cholesterol (mg/dL) | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss). |
| Serum HDL cholesterol (mg/dl) | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss). |
| Serum glucose (mg/dl) | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss). |
| Serum insulin (U/ml) | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss). |
| Serum hemoglobin A1c (mmol/mol) | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss). |
| Serum triiodothyronine (ng/dL) | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss). |
| Serum thyroxine (ng/dL) | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss). |
| Sleep time (min) measured by accelerometry | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss). |
| Handgrip strength (kg) measured using a dynamometer | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss). |
| Meal-induced changes in insulin concentration (U/ml) in response to a standardized meal | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss). |
| Meal-induced changes in glucose concentration (mmol/L) in response to a standardized meal | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss). |
| Meal-induced changes in lactate concentrations (mmol/l) in response to a standardized meal | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss). |
| Meal-induced changes in triglycerides concentrations (mg/dl) in response to a standardized meal | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss). |
| Meal-induced changes in total cholesterol concentrations (mg/dL) in response to a standardized meal | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss). |
| Meal-induced changes in free fatty acids (mmol/L) in response to a standardized meal | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss). |
| Meal-induced changes in glycerol concentrations (mmol/l) in response to a standardized meal | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss). |
| Meal-induced changes in 3-hydroxybutyrate concentrations (mmol/L) in response to a standardized meal | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss). |
| Functional mobility measured by "Timed Up and Go (TUG)" test | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss). |
| Walking speed (m/s) measured by a gait speed test | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss). |
| Independence in activities of daily living (ADL) measured by "Barthel Index" | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss). |
| Food cravings measured using the "Food Craving Inventory" questionnaire | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss); 6 months after the end of dietary intervention; 12 months after the end of dietary intervention |
| Control of eating behavior measured using the "Control of Eating Weekly Questionnaire" | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss); 6 months after the end of dietary intervention; 12 months after the end of dietary intervention |
| Cognitive restriction of food intake measured using the "Three-Factor Eating Questionnaire" | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss); 6 months after the end of dietary intervention; 12 months after the end of dietary intervention |
| Food disinhibition measured using the "Three-Factor Eating Questionnaire" | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss); 6 months after the end of dietary intervention; 12 months after the end of dietary intervention |
| Subjective hunger measured using the "Three-Factor Eating Questionnaire" | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss); 6 months after the end of dietary intervention; 12 months after the end of dietary intervention |
| Binge eating behavior measured using the "Binge Eating Questionnaire" | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss); 6 months after the end of dietary intervention; 12 months after the end of dietary intervention |
| Fasting appetite-related sensations measured using "Visual Analogue Scales (VAS)" | The scales range from 0 to 100 | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss); 6 months after the end of dietary intervention; 12 months after the end of dietary intervention |
| Meal-induced changes in appetite-related sensations measured using "Visual Analogue Scales (VAS)" in response to a standardized meal | The scales range from 0 to 100 | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss). |
| Energy efficiency (W/Kcal) while cycling, assessed by indirect calorimetry | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss). |
| Vastus lateralis thickness (cm) measured by ultrasound | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss). |
| Subcutaneous fat thickness (cm) measured by ultrasound | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss). |
| Superficial fat thickness (cm) measured by ultrasound | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss). |
| Preperitoneal fat thickness (cm) measured by ultrasound | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss). |
| Carbohydrate intake (g/day) collected through three 24-hour recalls | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss); 6 months after the end of dietary intervention; 12 months after the end of dietary intervention |
| Fat intake (g/day) collected through three 24-hour recalls | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss); 6 months after the end of dietary intervention; 12 months after the end of dietary intervention |
| Protein intake (g/day) collected through three 24-hour recalls | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss); 6 months after the end of dietary intervention; 12 months after the end of dietary intervention |
| Fiber intake (g/day) collected through three 24-hour recalls | Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss); 6 months after the end of dietary intervention; 12 months after the end of dietary intervention |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |