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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
187
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.
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.
University of Granada - Instituto Mixto Universitario Deporte y Salud
Granada, Granada, Spain
University of Granada
Granada, Granada, Spain
Change in hepatic fat content
Hepatic fat content will be assessed by Magnetic Resonance Imaging (MRI)
Time frame: Change from baseline to 12 weeks
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.
Time frame: Change from baseline to 12 weeks
Change in values of alkaline phosphatase
Fasting blood samples will be used to asses alkaline phosphatase
Time frame: Change from baseline to 12 weeks
Change in values of alanine transaminase
Fasting blood samples will be used to asses alanine transaminase
Time frame: Change from baseline to 12 weeks
Change in values of gamma-glutamyl transferase
Fasting blood samples will be used to assess gamma-glutamyl transferase
Time frame: Change from baseline to 12 weeks
Change in visceral adipose tissue
Visceral adipose tissue will be assessed by Magnetic Resonance Imaging (MRI)
Time frame: Change from baseline to 12 weeks
Change in abdominal subcutaneous adipose tissue
Abdominal subcutaneous adipose tissue will be assessed by Magnetic Resonance Imaging (MRI)
Time frame: Change from baseline to 12 weeks
Change in visceral adipose tissue
Visceral adipose tissue will be assessed by Magnetic Resonance Imaging (MRI)
Time frame: Change from baseline to 12 months
Change in abdominal subcutaneous adipose tissue
Abdominal subcutaneous adipose tissue will be assessed by Magnetic Resonance Imaging (MRI)
Time frame: Change from baseline to 12 months
Change in pancreatic fat content
Pancreatic fat content will be assessed by Magnetic Resonance Imaging (MRI)
Time frame: Change from baseline to 12 weeks
Change in pancreatic fat content
Pancreatic fat content will be assessed by Magnetic Resonance Imaging (MRI)
Time frame: Change from baseline to 12 months
Change in values of fasting glucose
Fasting blood samples will be used to assess glucose
Time frame: 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
Time frame: Change from baseline to 12 weeks
Change in values of HbA1c
Fasting blood samples will be used to assess HbA1c
Time frame: Change from baseline to 12 weeks
Change in values of fasting triglycerides
Fasting blood samples will be used to assess levels of triglycerides
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Change from baseline to 12 weeks
Change in values of interleukin 6
Fasting blood samples will be used to assess levels of interleukin 6
Time frame: Change from baseline to 12 weeks
Change in values of apolipoprotein A1
Fasting blood samples will be used to assess levels of apolipoprotein A1
Time frame: Change from baseline to 12 weeks
Change in values of apolipoprotein B
Fasting blood samples will be used to assess levels of apolipoprotein B
Time frame: 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
Time frame: 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.
Time frame: Change in 2-hour plasma glucose baseline and 12 weeks
Change in Body weight
Body weight will be measured by a digital scale
Time frame: Change from baseline to 12 weeks
Change in Body weight
Body weight will be measured by a digital scale
Time frame: Change from baseline to 12 months
Change in Body height
Body height will be measured by a stadiometer
Time frame: Change from baseline to 12 weeks
Change in Body height
Body height will be measured by a stadiometer
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Change from baseline to 12 months
Change in systolic blood pressure
Systolic blood pressure will be assessed by blood pressure monitor
Time frame: Change from baseline to 12 weeks
Change in systolic blood pressure
Systolic blood pressure will be assessed by blood pressure monitor
Time frame: Change from baseline to 12 months
Change in diastolic blood pressure
Diastolic blood pressure will be assessed by blood pressure monitor
Time frame: Change from baseline to 12 weeks
Change in diastolic blood pressure
Diastolic blood pressure will be assessed by blood pressure monitor
Time frame: Change from baseline to 12 months
Change in energy intake
Energy intake (kcal/day) will be assessed by 24h recalls
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Change from baseline to 12 weeks
Change in Objectively sleep quality
Objectively sleep quality will be assessed by accelerometry
Time frame: Change from baseline to 12 weeks
Change in Chronotype
Chronotype will be assessed by the Munich Chronotype Questionnaire (MCTQ).
Time frame: 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.
Time frame: Change from baseline to 12 weeks
Change Objectively moderate to vigorous physical activity levels
Objectively physical activity levels will be assessed by accelerometry
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: Change from baseline to 12 weeks
Change in Cardiorespiratory Fitness
Cardiorespiratory fitness measured by maximum treadmill test
Time frame: Change from baseline to 12 weeks
Change in Lower muscular strength
Lower body muscular strength measured by chair stand test.
Time frame: Change from baseline to 12 weeks
Change in Upper muscular strength
Upper body muscular strength measured by hand grip strength test.
Time frame: Change from baseline to 12 weeks
Change in walking speed.
Walking speed measured by gait speed test. Higher values mean worse performance.
Time frame: Change from baseline to 12 weeks
Adherence to the eating window
Adherence will be assessed by eating records through the mobile phone app.
Time frame: During the 12 weeks
Attendance to the exercise intervention
Attendance will be assessed by number of completed exercise sessions.
Time frame: During the 12 weeks
Change in hepatic fat content
Hepatic fat content will be assessed by Magnetic Resonance Imaging (MRI)
Time frame: Change from baseline to 12 months
Change in abdominal intermuscular fat content
Abdominal intermuscular fat content will be assessed by Magnetic Resonance Imaging (MRI)
Time frame: Change from baseline to 12 weeks
Change in abdominal intermuscular fat content
Abdominal intermuscular fat content will be assessed by Magnetic Resonance Imaging (MRI)
Time frame: Change from baseline to 12 months
Change in abdominal skeletal muscle tissue
Abdominal skeletal muscle tissue will be assessed by Magnetic Resonance Imaging (MRI)
Time frame: Change from baseline to 12 months
Change in abdominal skeletal muscle tissue
Abdominal skeletal muscle tissue will be assessed by Magnetic Resonance Imaging (MRI)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Change from baseline to 12 months
Change in Fat Mass
Fat mass will be assessed by assessed by bioelectrical impedance analysis (BIA).
Time frame: Change from baseline to 12 weeks
Change in Fat Mass
Fat mass will be assessed by assessed by bioelectrical impedance analysis (BIA).
Time frame: Change from baseline to 12 months
Change in Fat-free Mass
Fat-free mass will be assessed by assessed by bioelectrical impedance analysis (BIA).
Time frame: Change from baseline to 12 weeks
Change in Fat-free Mass
Fat-free mass will be assessed by assessed by bioelectrical impedance analysis (BIA).
Time frame: 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).
Time frame: 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).
Time frame: Change from baseline to 12 weeks
Change in values of alkaline phosphatase
Fasting blood samples will be used to asses alkaline phosphatase
Time frame: Change from baseline to 12 months
Change in values of alanine transaminase
Fasting blood samples will be used to asses alanine transaminase
Time frame: Change from baseline to 12 months
Change in values of aspartate aminotransferase
Fasting blood samples will be used to asses aspartate aminotransferase
Time frame: Change from baseline to 12 weeks
Change in values of aspartate aminotransferase
Fasting blood samples will be used to asses aspartate aminotransferase
Time frame: Change from baseline to 12 months
Change in values of gamma-glutamyl transferase
Fasting blood samples will be used to assess gamma-glutamyl transferase
Time frame: Change from baseline to 12 months
Change in values of HbA1c
Fasting blood samples will be used to assess HbA1c
Time frame: Change from baseline to 12 months
Change in values of fasting glucose
Fasting blood samples will be used to assess glucose
Time frame: Change from baseline to 12 months
Change in values of fasting insulin
Fasting blood samples will be used to assess insulin
Time frame: Change from baseline to 12 weeks
Change in values of fasting insulin
Fasting blood samples will be used to assess insulin
Time frame: 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
Time frame: Change from baseline to 12 months
Change in values of fasting triglycerides
Fasting blood samples will be used to assess levels of triglycerides
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Change from baseline to 12 months
Change in values of apolipoprotein A1
Fasting blood samples will be used to assess levels of apolipoprotein A1
Time frame: Change from baseline to 12 months
Change in values of apolipoprotein B
Fasting blood samples will be used to assess levels of apolipoprotein B
Time frame: 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
Time frame: Change from baseline to 12 months
Change in values of interleukin 6
Fasting blood samples will be used to assess levels of interleukin 6
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Change from baseline to 12 weeks
Change in rest-activity rhythms
Rest-activity rhythms will be assessed by accelerometry
Time frame: Change from baseline to the last 2 weeks of intervention
Change in steps counts
Steps counts will be assessed by activity band
Time frame: 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).
Time frame: Change from baseline to 6 weeks
Change in Fat-free Mass
Fat-free mass will be assessed by assessed by bioelectrical impedance analysis (BIA).
Time frame: Change from baseline to 6 weeks
Change in Body weight
Body weight will be measured by a digital scale
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Change from baseline to 6 weeks
Change in energy intake
Energy intake (kcal/day) will be assessed by 24h recalls
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Change from baseline to 12 months
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