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In Spain, overweight and obesity prevalence is reaching 70% in men and 50% in women. Excess of triglycerides are usually stored in the subcutaneous adipose tissue (SAT), until a point where SAT is unable to expand further. Therefore, lipids are deposited in visceral and other peripheral organs and tissues that are not otherwise designed for adipose storage such as the liver, pancreas or the skeletal muscle, a process known as ectopic fat deposition. "Time-restricted eating" (TRE) is a recently emerged intermittent fasting approach which has the potential to maximize the beneficial metabolic effects extensively reported for energy intake restriction. Furthermore, exercise reduces hepatic steatosis and improves cardiometabolic health in humans. However, whether the effects of TRE combined with exercise on reducing hepatic steatosis are superior to TRE or exercise intervention alone remains unknown. The TEMPUS study will investigate the effects of a 12-week TRE combined with supervised exercise intervention, as compared with TRE or exercise alone, and usual-care control group, on hepatic fat (primary outcome) and cardiometabolic health (secondary outcomes) in adults with obesity; and to unveil the role of gut microbiota.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Time-restricted eating intervention | Experimental | Participants will be asked to reduce their daily eating time window to a maximum of 8 hours/day. They can choose when to begin their eating window but will be advised that the last meal should be completed before or at 20:00 hours. No calorie-containing food or beverage intake will be allowed outside the 8 hours eating window. |
|
| Supervised exercise intervention | Experimental | The exercise intervention will include 2 days/week of supervised moderate-high intensity resistance training (rating perceived exertion >7, circuit-training, upper and lower body exercises involving major muscle groups) and high-intensity interval training (4 sets of 4-minute intervals at >85% peak heat rate with 4-minute of active recovery at 50-65% peak heat rate, uphill treadmill walking). Moreover, participants will receive an individualized moderate-intensity goal-setting aerobic (walking) program consisting of increasing 15% daily steps per week. |
|
| Usual-care control group | No Intervention | Participants will receive standard recommendations on healthy lifestyle based on Mediterranean dietary pattern and physical activity recommendations for weight loss and health promotion. | |
| Time-restricted eating plus Supervised exercise | Experimental | Participants will be asked to reduce their daily eating time window to a maximum of 8 hours/day. They can choose when to begin their eating window but will be advised that the last meal should be completed before or at 20:00 hours. No calorie-containing food or beverage intake will be allowed outside the 8 hours eating window. The exercise intervention will include 2 days/week of supervised moderate-high intensity resistance training (rating perceived exertion >7, circuit-training, upper and lower body exercises involving major muscle groups) and high-intensity interval training (4 sets of 4-minute intervals at >85% peak heat rate with 4-minute of active recovery at 50-65% peak heat rate, uphill treadmill walking). Moreover, participants will receive an individualized moderate-intensity goal- |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Time-restricted eating intervention | Behavioral | Participants will be asked to reduce their daily eating time window to a maximum of 8 hours/day. They can choose when to begin their eating window but will be advised that the last meal should be completed before or at 20:00 hours. No calorie-containing food or beverage intake will be allowed outside the 8 hours eating window. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in hepatic fat content | Hepatic fat content will be assessed by Magnetic Resonance Imaging (MRI) | Change from baseline to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in liver stiffness | The quantification of stiffness will be assessed using attenuation imaging, shear wave elastography and shear wave dispersion with a Canon Aplio i800. | Change from baseline to 12 weeks |
| Change in values of alkaline phosphatase |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonatan R. Ruiz, PhD | Universidad de Granada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Granada - Instituto Mixto Universitario Deporte y Salud | Granada | Granada | 18011 | Spain | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38267239 | Derived | Camacho-Cardenosa A, Clavero-Jimeno A, Martin-Olmedo JJ, Amaro-Gahete F, Cupeiro R, Cejudo MTG, Garcia Perez PV, Hernandez-Martinez C, Sevilla-Lorente R, De-la-O A, Lopez-Vazquez A, Molina-Fernandez M, Carneiro-Barrera A, Garcia F, Rodriguez-Nogales A, Galvez Peralta JJ, Cabeza R, Martin-Rodriguez JL, Munoz-Garach A, Munoz-Torres M, Labayen I, Ruiz JR. Time-restricted eating and supervised exercise for improving hepatic steatosis and cardiometabolic health in adults with obesity: protocol for the TEMPUS randomised controlled trial. BMJ Open. 2024 Jan 24;14(1):e078472. doi: 10.1136/bmjopen-2023-078472. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 1, 2024 | Jul 31, 2025 |
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| Exercise intervention | Behavioral | The exercise intervention will include 2 days/week of supervised moderate-high intensity resistance training (rating perceived exertion >7, circuit-training, upper and lower body exercises involving major muscle groups) and high-intensity interval training (4 sets of 4-minute intervals at >85% peak heat rate with 4-minute of active recovery at 50-65% peak heat rate, uphill treadmill walking). This intervention has already been tested previously in our lab. Moreover, participants will receive an individualized moderate-intensity goal-setting aerobic (walking) program consisting of increasing 15% daily steps per week. |
|
| Time-restricted eating plus exercise intervention | Behavioral | Participants will be asked to reduce their daily eating time window to a maximum of 8 hours/day. They can choose when to begin their eating window but will be advised that the last meal should be completed before or at 20:00 hours. No calorie-containing food or beverage intake will be allowed outside the 8 hours eating window. The exercise intervention will include 2 days/week of supervised moderate-high intensity resistance training (rating perceived exertion >7, circuit-training, upper and lower body exercises involving major muscle groups) and high-intensity interval training (4 sets of 4-minute intervals at >85% peak heat rate with 4-minute of active recovery at 50-65% peak heat rate, uphill treadmill walking). This intervention has already been tested previously in our lab. Moreover, participants will receive an individualized moderate-intensity goal-setting aerobic (walking) program consisting of increasing 15% daily steps per week. |
|
Fasting blood samples will be used to asses alkaline phosphatase |
| Change from baseline to 12 weeks |
| Change in values of alanine transaminase | Fasting blood samples will be used to asses alanine transaminase | Change from baseline to 12 weeks |
| Change in values of gamma-glutamyl transferase | Fasting blood samples will be used to assess gamma-glutamyl transferase | Change from baseline to 12 weeks |
| Change in visceral adipose tissue | Visceral adipose tissue will be assessed by Magnetic Resonance Imaging (MRI) | Change from baseline to 12 weeks |
| Change in abdominal subcutaneous adipose tissue | Abdominal subcutaneous adipose tissue will be assessed by Magnetic Resonance Imaging (MRI) | Change from baseline to 12 weeks |
| Change in visceral adipose tissue | Visceral adipose tissue will be assessed by Magnetic Resonance Imaging (MRI) | Change from baseline to 12 months |
| Change in abdominal subcutaneous adipose tissue | Abdominal subcutaneous adipose tissue will be assessed by Magnetic Resonance Imaging (MRI) | Change from baseline to 12 months |
| Change in pancreatic fat content | Pancreatic fat content will be assessed by Magnetic Resonance Imaging (MRI) | Change from baseline to 12 weeks |
| Change in pancreatic fat content | Pancreatic fat content will be assessed by Magnetic Resonance Imaging (MRI) | Change from baseline to 12 months |
| Change in values of fasting glucose | Fasting blood samples will be used to assess glucose | Change from baseline to 12 weeks |
| Change in HOMA-IR index. | Fasting blood samples will be used to assess glucose and insulin and HOMA index will be computed | Change from baseline to 12 weeks |
| Change in values of HbA1c | Fasting blood samples will be used to assess HbA1c | Change from baseline to 12 weeks |
| Change in values of fasting triglycerides | Fasting blood samples will be used to assess levels of triglycerides | Change from baseline to 12 weeks |
| Change in values of fasting high-density lipoprotein cholesterol | Fasting blood samples will be used to assess levels of high-density lipoprotein cholesterol | Change from baseline to 12 weeks |
| Change in values of fasting low-density lipoprotein cholesterol | Fasting blood samples will be used to assess levels of low-density lipoprotein cholesterol | Change from baseline to 12 weeks |
| Change in values of fasting total cholesterol | Fasting blood samples will be used to assess levels of total cholesterol | Change from baseline to 12 weeks |
| Change in values of C-reactive protein | Fasting blood samples will be used to assess levels of C-reactive protein | Change from baseline to 12 weeks |
| Change in values of interleukin 6 | Fasting blood samples will be used to assess levels of interleukin 6 | Change from baseline to 12 weeks |
| Change in values of apolipoprotein A1 | Fasting blood samples will be used to assess levels of apolipoprotein A1 | Change from baseline to 12 weeks |
| Change in values of apolipoprotein B | Fasting blood samples will be used to assess levels of apolipoprotein B | Change from baseline to 12 weeks |
| Change in levels of mean glucose (Continuous Glucose Monitoring) | 24-hour, diurnal and nocturnal mean glucose over 14 days will be assessed by Continuous Glucose Monitoring during 2 weeks | Change from baseline to the last 2 weeks of intervention |
| Change in 2-hour plasma glucose | 2-hour plasma glucose will be assessed by oral glucose tolerance test. | Change in 2-hour plasma glucose baseline and 12 weeks |
| Change in Body weight | Body weight will be measured by a digital scale | Change from baseline to 12 weeks |
| Change in Body weight | Body weight will be measured by a digital scale | Change from baseline to 12 months |
| Change in Body height | Body height will be measured by a stadiometer | Change from baseline to 12 weeks |
| Change in Body height | Body height will be measured by a stadiometer | Change from baseline to 12 months |
| Change in waist circumference | Waist circumference will be assessed by measuring tape following the procedures outlined by the International Society for the Advancement of Kinanthropometry | Change from baseline to 12 weeks |
| Change in calf girth | Calf girth will be assessed by measuring tape following the procedures outlined by the International Society for the Advancement of Kinanthropometry | Change from baseline to 12 weeks |
| Change in waist circumference | Waist circumference will be assessed by measuring tape following the procedures outlined by the International Society for the Advancement of Kinanthropometry | Change from baseline to 12 months |
| Change in calf girth | Calf girth will be assessed by measuring tape following the procedures outlined by the International Society for the Advancement of Kinanthropometry | Change from baseline to 12 months |
| Change in hip circumference | Hip circumference will be assessed by measuring tape following the procedures outlined by the International Society for the Advancement of Kinanthropometry | Change from baseline to 12 weeks |
| Change in hip circumference | Hip circumference will be assessed by measuring tape following the procedures outlined by the International Society for the Advancement of Kinanthropometry | Change from baseline to 12 months |
| Change in neck circumference | Neck circumference will be assessed by measuring tape following the procedures outlined by the International Society for the Advancement of Kinanthropometry | Change from baseline to 12 weeks |
| Change in neck circumference | Neck circumference will be assessed by measuring tape following the procedures outlined by the International Society for the Advancement of Kinanthropometry | Change from baseline to 12 months |
| Change in systolic blood pressure | Systolic blood pressure will be assessed by blood pressure monitor | Change from baseline to 12 weeks |
| Change in systolic blood pressure | Systolic blood pressure will be assessed by blood pressure monitor | Change from baseline to 12 months |
| Change in diastolic blood pressure | Diastolic blood pressure will be assessed by blood pressure monitor | Change from baseline to 12 weeks |
| Change in diastolic blood pressure | Diastolic blood pressure will be assessed by blood pressure monitor | Change from baseline to 12 months |
| Change in energy intake | Energy intake (kcal/day) will be assessed by 24h recalls | Change from baseline to 12 weeks |
| Change in carbohydrates intake | Macronutrients intake (g/day and percentage of energy intake) will be assessed by 24h recalls | Change from baseline to 12 weeks |
| Change in fat intake | Fat intake (g/day and percentage of energy intake) will be assessed by 24h recalls | Change from baseline to 12 weeks |
| Change in protein intake | Protein intake (g/day and percentage of energy intake) will be assessed by 24h recalls | Change from baseline to 12 weeks |
| Change in dietary habits | Dietary habits will be assessed by food frequency questionnaire (FFQ). Minimum value is 1 (never) and maximum value is 9 (more than 6 times per day). Higher values mean a more frequency of a certain food consumption. | Change from baseline to 12 weeks |
| Change in Appetite traits | Appetite traits will be assessed by the Adult Eating Behavior Questionnaire (AEBQ). Minimum value is 1 (completely disagree) and maximum value is 5 (completely agree). Higher values mean a worse outcome. | Change from baseline to 12 weeks |
| Change in Subjective sleep quality | Subjective sleep quality will be assessed by the Pittsburgh Sleep Quality Index (PSQI). Minimum value is 0 (never) and maximum value is 3 (3 or more times per week). Higher values mean a worse outcome. | Change from baseline to 12 weeks |
| Change in Objectively sleep quality | Objectively sleep quality will be assessed by accelerometry | Change from baseline to 12 weeks |
| Change in Chronotype | Chronotype will be assessed by the Munich Chronotype Questionnaire (MCTQ). | Change from baseline to 12 weeks |
| Change in Morning-Evening type | Morning-Evening type will be assessed by the Morningness-Eveningness Questionnaire Self-Assessment Version. Define if a person is more morningness or eveningness based on daily times preferences. | Change from baseline to 12 weeks |
| Change Objectively moderate to vigorous physical activity levels | Objectively physical activity levels will be assessed by accelerometry | Change from baseline to 12 weeks |
| Change in Depression aspects | Depression aspects will be assessed by the Beck Depression Inventory Fast Screen (BDI-FS). Values ranged from 0 to 63. Higher values mean worse outcome. | Change from baseline to 12 weeks |
| Change in Stress aspects | Stress aspects will be assessed by the Perceived Stress Scale (PSS). Values ranged from 0 to 40. Higher values mean worse outcome. | Change from baseline to 12 weeks |
| Change in Anxiety aspects | Anxiety aspects will be assessed by the State-Trait Anxiety Inventory (STAI). Values ranged from 0 to 60. Higher values mean worse outcome. | Change from baseline to 12 weeks |
| Change in General health | General health will be assessed by the EuroQol 5 dimensions 5 levels (EQ-5D-5L). Values ranged from 0 to 100. Higher values mean better outcome. | Change from baseline to 12 weeks |
| Change in Quality of life | Quality of life will be assessed by the Rand Short Form 36 (SF-36). Values ranged from 0 to 100. Higher values mean better outcome. | Change from baseline to 12 weeks |
| Change in fecal microbiota composition | Shotgun metagenomic sequencing of DNA extracted from stool samples to determine taxonomic profiling (e.g., phylum, genera, species). | Change from baseline to 12 weeks |
| Change in fecal microbiota diversity | Shotgun metagenomic sequencing of DNA extracted from stool samples to determine fecal microbiota diversity (e.g., beta and alpha diversity metrics). | Change from baseline to 12 weeks |
| Change in Cardiorespiratory Fitness | Cardiorespiratory fitness measured by maximum treadmill test | Change from baseline to 12 weeks |
| Change in Lower muscular strength | Lower body muscular strength measured by chair stand test. | Change from baseline to 12 weeks |
| Change in Upper muscular strength | Upper body muscular strength measured by hand grip strength test. | Change from baseline to 12 weeks |
| Change in walking speed. | Walking speed measured by gait speed test. Higher values mean worse performance. | Change from baseline to 12 weeks |
| Adherence to the eating window | Adherence will be assessed by eating records through the mobile phone app. | During the 12 weeks |
| Attendance to the exercise intervention | Attendance will be assessed by number of completed exercise sessions. | During the 12 weeks |
| Change in hepatic fat content | Hepatic fat content will be assessed by Magnetic Resonance Imaging (MRI) | Change from baseline to 12 months |
| Change in abdominal intermuscular fat content | Abdominal intermuscular fat content will be assessed by Magnetic Resonance Imaging (MRI) | Change from baseline to 12 weeks |
| Change in abdominal intermuscular fat content | Abdominal intermuscular fat content will be assessed by Magnetic Resonance Imaging (MRI) | Change from baseline to 12 months |
| Change in abdominal skeletal muscle tissue | Abdominal skeletal muscle tissue will be assessed by Magnetic Resonance Imaging (MRI) | Change from baseline to 12 months |
| Change in abdominal skeletal muscle tissue | Abdominal skeletal muscle tissue will be assessed by Magnetic Resonance Imaging (MRI) | Change from baseline to 12 weeks |
| Change in mid-thigh subcutaneous adipose tissue | Mid-thigh subcutaneous adipose tissue will be assessed by Magnetic Resonance Imaging (MRI) | Change from baseline to 12 weeks |
| Change in mid-thigh subcutaneous adipose tissue | Mid-thigh subcutaneous adipose tissue will be assessed by Magnetic Resonance Imaging (MRI) | Change from baseline to 12 months |
| Change in mid-thigh intermuscular fat content | Mid-thigh intermuscular fat content will be assessed by Magnetic Resonance Imaging (MRI) | Change from baseline to 12 weeks |
| Change in mid-thigh intermuscular fat content | Mid-thigh intermuscular fat content will be assessed by Magnetic Resonance Imaging (MRI) | Change from baseline to 12 months |
| Change in mid-thigh intramuscular fat content | Mid-thigh intramuscular fat content will be assessed by Magnetic Resonance Imaging (MRI) | Change from baseline to 12 weeks |
| Change in mid-thigh intramuscular fat content | Mid-thigh intramuscular fat content will be assessed by Magnetic Resonance Imaging (MRI) | Change from baseline to 12 months |
| Change in mid-thigh skeletal muscle tissue | Mid-thigh skeletal muscle tissue will be assessed by Magnetic Resonance Imaging (MRI) | Change from baseline to 12 weeks |
| Change in mid-thigh skeletal muscle tissue | Mid-thigh skeletal muscle tissue will be assessed by Magnetic Resonance Imaging (MRI) | Change from baseline to 12 months |
| Change in liver stiffness | The quantification of stiffness will be assessed using attenuation imaging, shear wave elastography and shear wave dispersion with a Canon Aplio i800. | Change from baseline to 12 months |
| Change in liver steatosis | The quantification of steatosis will be assessed using attenuation imaging, shear wave elastography and shear wave dispersion with a Canon Aplio i800. | Change from baseline to 12 weeks |
| Change in liver steatosis | The quantification of steatosis will be assessed using attenuation imaging, shear wave elastography and shear wave dispersion with a Canon Aplio i800. | Change from baseline to 12 months |
| Change in liver viscosity | The quantification of viscosity will be assessed using attenuation imaging, shear wave elastography and shear wave dispersion with a Canon Aplio i800. | Change from baseline to 12 weeks |
| Change in liver viscosity | The quantification of viscosity will be assessed using attenuation imaging, shear wave elastography and shear wave dispersion with a Canon Aplio i800. | Change from baseline to 12 months |
| Change in Fat Mass | Fat mass will be assessed by assessed by bioelectrical impedance analysis (BIA). | Change from baseline to 12 weeks |
| Change in Fat Mass | Fat mass will be assessed by assessed by bioelectrical impedance analysis (BIA). | Change from baseline to 12 months |
| Change in Fat-free Mass | Fat-free mass will be assessed by assessed by bioelectrical impedance analysis (BIA). | Change from baseline to 12 weeks |
| Change in Fat-free Mass | Fat-free mass will be assessed by assessed by bioelectrical impedance analysis (BIA). | Change from baseline to 12 months |
| Change in Bone Mineral Density | Bone mineral density will be assessed by dual-energy X-ray absorptiometry scans (DXA). | Change from baseline to 12 months |
| Change in Bone Mineral Density | Bone mineral density will be assessed by dual-energy X-ray absorptiometry scans (DXA). | Change from baseline to 12 weeks |
| Change in values of alkaline phosphatase | Fasting blood samples will be used to asses alkaline phosphatase | Change from baseline to 12 months |
| Change in values of alanine transaminase | Fasting blood samples will be used to asses alanine transaminase | Change from baseline to 12 months |
| Change in values of aspartate aminotransferase | Fasting blood samples will be used to asses aspartate aminotransferase | Change from baseline to 12 weeks |
| Change in values of aspartate aminotransferase | Fasting blood samples will be used to asses aspartate aminotransferase | Change from baseline to 12 months |
| Change in values of gamma-glutamyl transferase | Fasting blood samples will be used to assess gamma-glutamyl transferase | Change from baseline to 12 months |
| Change in values of HbA1c | Fasting blood samples will be used to assess HbA1c | Change from baseline to 12 months |
| Change in values of fasting glucose | Fasting blood samples will be used to assess glucose | Change from baseline to 12 months |
| Change in values of fasting insulin | Fasting blood samples will be used to assess insulin | Change from baseline to 12 weeks |
| Change in values of fasting insulin | Fasting blood samples will be used to assess insulin | Change from baseline to 12 months |
| Change in HOMA-IR index. | Fasting blood samples will be used to assess glucose and insulin and HOMA index will be computed | Change from baseline to 12 months |
| Change in values of fasting triglycerides | Fasting blood samples will be used to assess levels of triglycerides | Change from baseline to 12 months |
| Change in values of fasting high-density lipoprotein cholesterol | Fasting blood samples will be used to assess levels of high-density lipoprotein cholesterol | Change from baseline to 12 months |
| Change in values of fasting low-density lipoprotein cholesterol | Fasting blood samples will be used to assess levels of low-density lipoprotein cholesterol | Change from baseline to 12 months |
| Change in values of fasting total cholesterol | Fasting blood samples will be used to assess levels of total cholesterol | Change from baseline to 12 months |
| Change in values of apolipoprotein A1 | Fasting blood samples will be used to assess levels of apolipoprotein A1 | Change from baseline to 12 months |
| Change in values of apolipoprotein B | Fasting blood samples will be used to assess levels of apolipoprotein B | Change from baseline to 12 months |
| Change in values of C-reactive protein | Fasting blood samples will be used to assess levels of C-reactive protein | Change from baseline to 12 months |
| Change in values of interleukin 6 | Fasting blood samples will be used to assess levels of interleukin 6 | Change from baseline to 12 months |
| Change in values of essential amino acids | Fasting urine samples will be used to assess levels of essential amino acids. | Change from baseline to 12 weeks |
| Change in values of non-essential amino acids | Fasting urine samples will be used to assess levels of essential amino acids. | Change from baseline to 12 weeks |
| Change in fiber intake | Fiber intake (g/day and percentage of energy intake) will be assessed by 24h recalls | Change from baseline to 12 weeks |
| Change in rest-activity rhythms | Rest-activity rhythms will be assessed by accelerometry | Change from baseline to the last 2 weeks of intervention |
| Change in steps counts | Steps counts will be assessed by activity band | Change from baseline to the last 2 weeks of intervention |
| Change in Fat Mass | Fat mass will be assessed by assessed by bioelectrical impedance analysis (BIA). | Change from baseline to 6 weeks |
| Change in Fat-free Mass | Fat-free mass will be assessed by assessed by bioelectrical impedance analysis (BIA). | Change from baseline to 6 weeks |
| Change in Body weight | Body weight will be measured by a digital scale | Change from baseline to 6 weeks |
| Change in waist circumference | Waist circumference will be assessed by measuring tape following the procedures outlined by the International Society for the Advancement of Kinanthropometry | Change from baseline to 6 weeks |
| Change in hip circumference | Hip circumference will be assessed by measuring tape following the procedures outlined by the International Society for the Advancement of Kinanthropometry | Change from baseline to 6 weeks |
| Change in neck circumference | Neck circumference will be assessed by measuring tape following the procedures outlined by the International Society for the Advancement of Kinanthropometry | Change from baseline to 6 weeks |
| Change in calf girth | Calf girth will be assessed by measuring tape following the procedures outlined by the International Society for the Advancement of Kinanthropometry | Change from baseline to 6 weeks |
| Change in Bone Mineral Density | Bone mineral density will be assessed by dual-energy X-ray absorptiometry scans (DXA). | Change from baseline to 6 weeks |
| Change in fecal microbiota functionality | Shotgun metagenomic sequencing of DNA extracted from stool samples to determine microbial functional capacity through the analysis of metabolic pathways. | Change from baseline to 12 weeks |
| Change in fiber intake | Fiber intake (g/day and percentage of energy intake) will be assessed by 24h recalls | Change from baseline to 6 weeks |
| Change in carbohydrates intake | Macronutrients intake (g/day and percentage of energy intake) will be assessed by 24h recalls | Change from baseline to 6 weeks |
| Change in protein intake | Protein intake (g/day and percentage of energy intake) will be assessed by 24h recalls | Change from baseline to 6 weeks |
| Change in energy intake | Energy intake (kcal/day) will be assessed by 24h recalls | Change from baseline to 6 weeks |
| Change in fat intake | Fat intake (g/day and percentage of energy intake) will be assessed by 24h recalls | Change from baseline to 6 weeks |
| Change in adherence to Mediterranean diet | Adherence to the Mediterranean dietary pattern will be assessed using validated questionnaires such as the PREDIMED questionnaire. The minimum value is 0 and the maximum value is 14. Higher values indicate better adherence to the Mediterranean diet and represent a better outcome. | Change from baseline to 6 weeks |
| Change in adherence to Mediterranean diet | Adherence to the Mediterranean dietary pattern will be assessed using validated questionnaires such as the PREDIMED questionnaire. The minimum value is 0 and the maximum value is 14. Higher values indicate better adherence to the Mediterranean diet and represent a better outcome. | Change from baseline to 12 weeks |
| Change in adherence to Mediterranean diet | Adherence to the Mediterranean dietary pattern will be assessed using validated questionnaires such as the PREDIMED questionnaire. The minimum value is 0 and the maximum value is 14. Higher values indicate better adherence to the Mediterranean diet and represent a better outcome. | Change from baseline to 12 months |
| University of Granada |
| Granada |
| Granada |
| 18011 |
| Spain |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 1, 2024 | Jul 31, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000093763 | Intermittent Fasting |
| D009043 | Motor Activity |
| D005234 | Fatty Liver |
| D024821 | Metabolic Syndrome |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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