Time-Restricted Eating, Exercise and Cardiometabolic Health in Obesity
- Conditions
- ExerciseHepatic SteatosisCardiometabolic SyndromeObesityTime Restricted Feeding
- Interventions
- Behavioral: Time-restricted eating interventionBehavioral: Exercise interventionBehavioral: Time-restricted eating plus exercise intervention
- Registration Number
- NCT05897073
- Lead Sponsor
- Universidad de Granada
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 184
- Aged 25-65 years.
- Body mass index ≥28.0 and <40.0 kg/m2.
- Weight stability (within 5% of screening weight) for >3 months prior to study entry.
- Habitual eating window ≥11 hours.
- History of a major adverse cardiovascular event, clinically significant kidney, endocrine, or neurological disease, bariatric surgery, HIV/AIDS, known inflammatory and/or rheumatologic disease, cancer, or other medical condition in which fasting or exercise is contraindicated.
- Type 1 or Type 2 diabetes.
- Major psychiatric disorders, eating disorders, sleep disorders, or alcohol abuse.
- Regular use of medication or compounds that may affect study outcomes (e.g., antidiabetic, steroids, beta-blockers, antibiotics, prebiotics, probiotics and symbiotics).
- Participating in a weight loss, a weight-management program or a supervised exercise program (more than 30 minutes three times per week, or 45 minutes twice a week, moderate/vigorous intensity).
- Pregnancy and lactation or planned pregnancy (within the study period).
- Caregiver for a dependent requiring frequent nocturnal care/sleep interruptions. Shift workers with variable hours (e.g., nocturnal).
- Frequent travel over time zones during the study period.
- Fear of needles and claustrophobia to magnetic resonance imaging (MRI).
- Being unable to understand and to accept the instructions or the study objectives and protocol.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Time-restricted eating intervention Time-restricted eating intervention 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 Exercise intervention 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. Time-restricted eating plus Supervised exercise Time-restricted eating plus exercise intervention 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-
- Primary Outcome Measures
Name Time Method Change in hepatic fat content Change from baseline to 12 weeks Hepatic fat content will be assessed by Magnetic Resonance Imaging (MRI)
- Secondary Outcome Measures
Name Time Method Change in fat mass Change from 12 weeks of intervention to 12 months Fat mass will be assessed by Dual-energy X-ray Absorptiometry (DXA)
Change in fat free mass Change from 12 weeks of intervention to 12 months Fat free mass will be assessed by Dual-energy X-ray Absorptiometry (DXA)
Change in values of ferritin Change from baseline to 12 weeks Fasting blood samples will be used to assess levels of ferritin
Change in values of fasting glucose Change from baseline to 12 weeks Fasting blood samples will be used to assess glucose
Change in values of alanine transaminase Change from baseline to 12 weeks Fasting blood samples will be used to asses alanine transaminase
Change in values of Vitamin D Change from baseline to 12 weeks Fasting blood samples will be used to assess Vitamin D
Change in values of Calcium Change from baseline to 12 weeks Fasting blood samples will be used to assess Calcium
Change in values of estradiol Change from baseline to 12 weeks Fasting blood samples will be used to assess estradiol
Change in values of progesterone Change from baseline to 12 weeks Fasting blood samples will be used to assess progesterone
Change in pancreatic fat content Change from 12 weeks of intervention to 12 months Pancreatic fat content will be assessed by Magnetic Resonance Imaging (MRI)
Change in intramuscular fat content Change from 12 weeks of intervention to 12 months Intramuscular fat content will be assessed by Magnetic Resonance Imaging (MRI)
Change in hepatic elasticity Change from baseline to 12 weeks Viscosity, fibrosis severity and steatosis will be assessed by US elastography
Change in values of alkaline phosphatase Change from baseline to 12 weeks Fasting blood samples will be used to asses alkaline phosphatase
Change in values of testosterone Change from baseline to 12 weeks Fasting blood samples will be used to assess testosterone
Change in abdominal subcutaneous adipose tissue Change from 12 weeks of intervention to 12 months Abdominal subcutaneous adipose tissue will be assessed by Magnetic Resonance Imaging (MRI)
Change in values of fasting triglycerides Change from baseline to 12 weeks Fasting blood samples will be used to assess levels of triglycerides
Change in values of creatinine Change from baseline to 12 weeks Fasting blood samples will be used to assess levels of creatinine
Change in values of gamma-glutamyl transferase Change from baseline to 12 weeks Fasting blood samples will be used to assess gamma-glutamyl transferase
Change in values of Bilrubin Change from baseline to 12 weeks Fasting blood samples will be used to assess Bilrubin
Change in values of glomerular filtration rate Change from baseline to 12 weeks Fasting blood samples will be used to assess glomerular filtration rate
Change in values of thyroxine Change from baseline to 12 weeks Fasting blood samples will be used to assess thyroxine
Change in values of triiodothyronine Change from baseline to 12 weeks Fasting blood samples will be used to assess triiodothyronine
Change in values of follicle stimulating hormone Change from baseline to 12 weeks Fasting blood samples will be used to assess follicle stimulating hormone
Change in values of luteinizing hormone Change from baseline to 12 weeks Fasting blood samples will be used to assess luteinizing hormone
Change in values of thyrotropin Change from baseline to 12 weeks Fasting blood samples will be used to assess thyrotropin
Change in visceral adipose tissue Change from 12 weeks of intervention to 12 months Visceral adipose tissue will be assessed by Magnetic Resonance Imaging (MRI)
Change in HOMA-IR index. Change from baseline to 12 weeks Fasting blood samples will be used to assess glucose and insuline and HOMA index will be computed
Change in values of creatine kinase Change from baseline to 12 weeks Fasting blood samples will be used to assess levels of creatine kinase
Change in calf girth Change from 12 weeks of intervention to 12 months Calf girth will be assessed by measuring tape following the procedures outlined by the International Society for the Advancement of Kinanthropometry
Change in hip circumference Change from 12 weeks of intervention to 12 months Hip circumference will be assessed by measuring tape following the procedures outlined by the International Society for the Advancement of Kinanthropometry
Change in carbohydrates intake Change from baseline to 12 weeks Macronutrients intake (g/day and percentage of energy intake) will be assessed by 24h recalls
Change in protein intake Change from baseline to 12 weeks Protein intake (g/day and percentage of energy intake) will be assessed by 24h recalls
Change in Morning-Evening type Change from baseline to 12 weeks 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 Objectively moderate to vigorous physical activity levels Change from baseline to 12 weeks Objectively physical activity levels will be assessed by accelerometry
Change in Depression aspects Change from baseline to 12 weeks 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 in Anxiety aspects Change from baseline to 12 weeks Anxiety aspects will be assessed by the State-Trait Anxiety Inventory (STAI). Values ranged from 0 to 60. Higher values mean worse outcome.
Change in Quality of life Change from baseline to 12 weeks 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 in Gut microbiota composition Change from baseline to 12 weeks DNA sequencing to determine gut microbiota composition (e.g., phylum and genera)
Change in values of HbA1c Change from baseline to 12 weeks Fasting blood samples will be used to assess HbA1c
Change in values of fasting low-density lipoprotein cholesterol Change from baseline to 12 weeks Fasting blood samples will be used to assess levels of low-density lipoprotein cholesterol
Change in values of C-reactive protein Change from baseline to 12 weeks Fasting blood samples will be used to assess levels of C-reactive protein
Change in values of folic acid Change from baseline to 12 weeks Fasting blood samples will be used to assess levels of folic acid
Change in bone mineral density Change from 12 weeks of intervention to 12 months Bone mineral density will be assessed by Dual-energy X-ray Absorptiometry (DXA)
Change in systolic blood pressure Change from 12 weeks of intervention to 12 months Systolic blood pressure will be assessed by blood pressure monitor
Change in fat intake Change from baseline to 12 weeks Fat intake (g/day and percentage of energy intake) will be assessed by 24h recalls
Change in dietary habits Change from baseline to 12 weeks 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 in Chronotype Change from baseline to 12 weeks Chronotype will be assessed by the Munich Chronotype Questionnaire (MCTQ).
Change in Upper muscular strength Change from baseline to 12 weeks Upper body muscular strength measured by hand grip strength test.
Adherence to the time-restricted eating intervention Change from baseline to 12 weeks Adherence will be assessed by eating records through the mobile phone app.
Change in values of fasting high-density lipoprotein cholesterol Change from baseline to 12 weeks Fasting blood samples will be used to assess levels of high-density lipoprotein cholesterol
Change in values of fasting total cholesterol Change from baseline to 12 weeks Fasting blood samples will be used to assess levels of total cholesterol
Change in neck circumference Change from 12 weeks of intervention to 12 months Neck circumference will be assessed by measuring tape following the procedures outlined by the International Society for the Advancement of Kinanthropometry
Change in diastolic blood pressure Change from 12 weeks of intervention to 12 months Diastolic blood pressure will be assessed by blood pressure monitor
Change in Stress aspects Change from baseline to 12 weeks Stress aspects will be assessed by the Perceived Stress Scale (PSS). Values ranged from 0 to 40. Higher values mean worse outcome.
Change in values of interleukin 6 Change from baseline to 12 weeks Fasting blood samples will be used to assess levels of interleukin 6
Change in values of iron Change from baseline to 12 weeks Fasting blood samples will be used to assess levels of iron
Change in values of apolipoprotein A1 Change from baseline to 12 weeks Fasting blood samples will be used to assess levels of apolipoprotein A1
Change in values of apolipoprotein B Change from baseline to 12 weeks Fasting blood samples will be used to assess levels of apolipoprotein B
Change in levels of mean glucose (Continuous Glucose Monitoring) Change from baseline to the last 2 weeks of intervention Men glucose over 14 days will be assessed by Continuous Glucose Monitoring during 2 weeks
Change in quantitative insulin-sensitivity check index Change from baseline to the last 2 weeks of intervention Quantitative insulin-sensitivity check index will be assessed by oral glucose tolerance test
Change in Body weight Change from 12 weeks of intervention to 12 months Body weight will be measured by a digital scale
Change in Body height Change from 12 weeks of intervention to 12 months Body height will be measured by a stadiometer
Change in waist circumference Change from 12 weeks of intervention to 12 months Waist circumference will be assessed by measuring tape following the procedures outlined by the International Society for the Advancement of Kinanthropometry
Change in Appetite traits Change from baseline to 12 weeks 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 in energy intake Change from baseline to 12 weeks Energy intake (kcal/day) will be assessed by 24h recalls
Change in Subjective sleep quality Change from baseline to 12 weeks 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 in Objectively sleep quality Change from baseline to 12 weeks Objectively sleep quality will be assessed by accelerometry
Change in General health Change from baseline to 12 weeks 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.
Adherence to the exercise intervention Change from baseline to 12 weeks Adherence will be assessed by number of completed exercise sessions.
Change in fecal microbiota diversity Change from baseline to 12 weeks DNA sequencing to determine gut microbiota diversity (e.g., beta and alpha)
Change in Cardiorespiratory Fitness Change from baseline to 12 weeks Cardiorespiratory fitness measured by maximum treadmill test
Change in Lower muscular strength Change from baseline to 12 weeks Lower body muscular strength measured by chair stand test.
Change in walking speed. Change from baseline to 12 weeks Walking speed measured by gait speed test. Higher values mean worse performance.
Change in hepatic fat content Change from 12 weeks of intervention to 12 months Hepatic fat content will be assessed by Magnetic Resonance Imaging (MRI)
Trial Locations
- Locations (2)
University of Granada - Instituto Mixto Universitario Deporte y Salud
🇪🇸Granada, Spain
University of Granada
🇪🇸Granada, Spain