Back to resultsTime-Restricted Eating, Exercise and Cardiometabolic Health in Obesity (TEMPUS)
Primary Purpose
Time Restricted Feeding, Exercise, Hepatic Steatosis
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Time-restricted eating intervention
Exercise intervention
Time-restricted eating plus exercise intervention
Sponsored by
About this trial
This is an interventional treatment trial for Time Restricted Feeding
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Sites / Locations
- University of Granada - Instituto Mixto Universitario Deporte y SaludRecruiting
- University of GranadaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
No Intervention
Experimental
Arm Label
Time-restricted eating intervention
Supervised exercise intervention
Usual-care control group
Time-restricted eating plus Supervised exercise
Arm Description
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-setting aerobic (walking) program consisting of increasing 15% daily steps per week.
Participants will receive standard recommendations on healthy lifestyle based on Mediterranean dietary pattern and physical activity recommendations for weight loss and health promotion.
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-
Outcomes
Primary Outcome Measures
Change in hepatic fat content
Hepatic fat content will be assessed by Magnetic Resonance Imaging (MRI)
Secondary Outcome Measures
Change in hepatic elasticity
Hepatic elasticity will be assessed by US elastography
Change in values of alkaline phosphatase
Fasting blood samples will be used to asses alkaline phosphatase
Change in values of alanine transaminase
Fasting blood samples will be used to asses alanine transaminase
Change in values of gamma-glutamyl transferase
Fasting blood samples will be used to assess gamma-glutamyl transferase
Change in visceral adipose tissue
Visceral adipose tissue will be assessed by Magnetic Resonance Imaging (MRI)
Change in visceral adipose tissue
Visceral adipose tissue will be assessed by Magnetic Resonance Imaging (MRI)
Change in pancreatic fat content
Pancreatic fat content will be assessed by Magnetic Resonance Imaging (MRI)
Change in pancreatic fat content
Pancreatic fat content will be assessed by Magnetic Resonance Imaging (MRI)
Change in intramuscular fat content
Intramuscular fat content will be assessed by Magnetic Resonance Imaging (MRI)
Change in intramuscular fat content
Intramuscular fat content will be assessed by Magnetic Resonance Imaging (MRI)
Change in values of fasting glucose
Fasting blood samples will be used to assess glucose
Change in HOMA-IR index.
Fasting blood samples will be used to assess glucose and insuline and HOMA index will be computed
Change in values of HbA1c.
Fasting blood samples will be used to assess HbA1c
Change in values of fasting triglycerides
Fasting blood samples will be used to assess levels of triglycerides
Change in values of fasting high-density lipoprotein cholesterol
Fasting blood samples will be used to assess levels of high-density lipoprotein cholesterol
Change in values of fasting low-density lipoprotein cholesterol
Fasting blood samples will be used to assess levels of low-density lipoprotein cholesterol
Change in values of fasting total cholesterol
Fasting blood samples will be used to assess levels of total cholesterol
Change in values of C-reactive protein
Fasting blood samples will be used to assess levels of C-reactive protein
Change in values of interleukin 6
Fasting blood samples will be used to assess levels of interleukin 6
Change in values of creatinine
Fasting blood samples will be used to assess levels of creatinine
Change in values of creatine kinase
Fasting blood samples will be used to assess levels of creatine kinase
Change in levels of mean glucose (Continuous Glucose Monitoring)
Men glucose over 14 days will be assessed by Continuous Glucose Monitoring during 2 weeks
Change in Body weight
Body weight will be measured by a digital scale
Change in Body weight
Body weight will be measured by a digital scale
Change in Body height
Body height will be measured by a stadiometer
Change in Body height
Body height will be measured by a stadiometer
Change in Fat mass
Fat mass will be assessed by Dual-energy X-ray Absorptiometry (DXA)
Change in fat free mass
Fat free mass will be assessed by Dual-energy X-ray Absorptiometry (DXA)
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 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 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 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 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 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 in systolic blood pressure
Systolic blood pressure will be assessed by blood pressure monitor
Change in systolic blood pressure
Systolic blood pressure will be assessed by blood pressure monitor
Change in diastolic blood pressure
Diastolic blood pressure will be assessed by blood pressure monitor
Change in diastolic blood pressure
Diastolic blood pressure will be assessed by blood pressure monitor
Change in energy intake
Energy intake (kcal/day) will be assessed by 24h recalls
Change in carbohydrates intake
Macronutrients intake (g/day and percentage of energy intake) will be assessed by 24h recalls
Change in fat intake
Fat intake (g/day and percentage of energy intake) will be assessed by 24h recalls
Change in protein intake
Protein intake (g/day and percentage of energy intake) will be assessed by 24h recalls
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 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 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 in Objectively sleep quality
Objectively sleep quality will be assessed by accelerometry
Change in Chronotype
Chronotype will be assessed by the Munich Chronotype Questionnaire (MCTQ).
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 Objectively moderate to vigorous physical activity levels
Objectively physical activity levels will be assessed by accelerometry
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 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 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 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 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 in Gut microbiota composition
DNA sequencing to determine gut microbiota composition (e.g., phylum and genera)
Change in Gut microbiota diversity
DNA sequencing to determine gut microbiota diversity (e.g., beta and alpha)
Change in Cardiorespiratory Fitness
Cardiorespiratory fitness measured by maximum treadmill test
Change in Lower muscular strength
Lower body muscular strength measured by chair stand test.
Change in Upper muscular strength
Upper body muscular strength measured by hand grip strength test.
Change in walking speed.
Walking speed measured by gait speed test. Higher values mean worse performance.
Adherence to the time-restricted eating intervention
Adherence will be assessed by eating records through the mobile phone app.
Adherence to the exercise intervention
Adherence will be assessed by number of completed exercise sessions.
Change in hepatic fat content
Hepatic fat content will be assessed by Magnetic Resonance Imaging (MRI)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05897073
Brief Title
Time-Restricted Eating, Exercise and Cardiometabolic Health in Obesity
Acronym
TEMPUS
Official Title
Impact of Time-Restricted Eating and Supervised Exercise on Hepatic Steatosis and Cardiometabolic Health in Adults With Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2, 2023 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Time Restricted Feeding, Exercise, Hepatic Steatosis, Cardiometabolic Syndrome, Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
184 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Time-restricted eating intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Supervised exercise intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual-care control group
Arm Type
No Intervention
Arm Description
Participants will receive standard recommendations on healthy lifestyle based on Mediterranean dietary pattern and physical activity recommendations for weight loss and health promotion.
Arm Title
Time-restricted eating plus Supervised exercise
Arm Type
Experimental
Arm Description
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-
Intervention Type
Behavioral
Intervention Name(s)
Time-restricted eating intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Time-restricted eating plus exercise intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in hepatic fat content
Description
Hepatic fat content will be assessed by Magnetic Resonance Imaging (MRI)
Time Frame
Change from baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Change in hepatic elasticity
Description
Hepatic elasticity will be assessed by US elastography
Time Frame
Change from baseline to 12 weeks
Title
Change in values of alkaline phosphatase
Description
Fasting blood samples will be used to asses alkaline phosphatase
Time Frame
Change from baseline to 12 weeks
Title
Change in values of alanine transaminase
Description
Fasting blood samples will be used to asses alanine transaminase
Time Frame
Change from baseline to 12 weeks
Title
Change in values of gamma-glutamyl transferase
Description
Fasting blood samples will be used to assess gamma-glutamyl transferase
Time Frame
Change from baseline to 12 weeks
Title
Change in visceral adipose tissue
Description
Visceral adipose tissue will be assessed by Magnetic Resonance Imaging (MRI)
Time Frame
Change from baseline to 12 weeks
Title
Change in visceral adipose tissue
Description
Visceral adipose tissue will be assessed by Magnetic Resonance Imaging (MRI)
Time Frame
Change from 12 weeks of intervention to 12 months
Title
Change in pancreatic fat content
Description
Pancreatic fat content will be assessed by Magnetic Resonance Imaging (MRI)
Time Frame
Change from baseline to 12 weeks
Title
Change in pancreatic fat content
Description
Pancreatic fat content will be assessed by Magnetic Resonance Imaging (MRI)
Time Frame
Change from 12 weeks of intervention to 12 months
Title
Change in intramuscular fat content
Description
Intramuscular fat content will be assessed by Magnetic Resonance Imaging (MRI)
Time Frame
Change from baseline to 12 weeks
Title
Change in intramuscular fat content
Description
Intramuscular fat content will be assessed by Magnetic Resonance Imaging (MRI)
Time Frame
Change from 12 weeks of intervention to 12 months
Title
Change in values of fasting glucose
Description
Fasting blood samples will be used to assess glucose
Time Frame
Change from baseline to 12 weeks
Title
Change in HOMA-IR index.
Description
Fasting blood samples will be used to assess glucose and insuline and HOMA index will be computed
Time Frame
Change from baseline to 12 weeks
Title
Change in values of HbA1c.
Description
Fasting blood samples will be used to assess HbA1c
Time Frame
Change from baseline to 12 weeks
Title
Change in values of fasting triglycerides
Description
Fasting blood samples will be used to assess levels of triglycerides
Time Frame
Change from baseline to 12 weeks
Title
Change in values of fasting high-density lipoprotein cholesterol
Description
Fasting blood samples will be used to assess levels of high-density lipoprotein cholesterol
Time Frame
Change from baseline to 12 weeks
Title
Change in values of fasting low-density lipoprotein cholesterol
Description
Fasting blood samples will be used to assess levels of low-density lipoprotein cholesterol
Time Frame
Change from baseline to 12 weeks
Title
Change in values of fasting total cholesterol
Description
Fasting blood samples will be used to assess levels of total cholesterol
Time Frame
Change from baseline to 12 weeks
Title
Change in values of C-reactive protein
Description
Fasting blood samples will be used to assess levels of C-reactive protein
Time Frame
Change from baseline to 12 weeks
Title
Change in values of interleukin 6
Description
Fasting blood samples will be used to assess levels of interleukin 6
Time Frame
Change from baseline to 12 weeks
Title
Change in values of creatinine
Description
Fasting blood samples will be used to assess levels of creatinine
Time Frame
Change from baseline to 12 weeks
Title
Change in values of creatine kinase
Description
Fasting blood samples will be used to assess levels of creatine kinase
Time Frame
Change from baseline to 12 weeks
Title
Change in levels of mean glucose (Continuous Glucose Monitoring)
Description
Men 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
Title
Change in Body weight
Description
Body weight will be measured by a digital scale
Time Frame
Change from baseline to 12 weeks
Title
Change in Body weight
Description
Body weight will be measured by a digital scale
Time Frame
Change from 12 weeks of intervention to 12 months
Title
Change in Body height
Description
Body height will be measured by a stadiometer
Time Frame
Change from baseline to 12 weeks
Title
Change in Body height
Description
Body height will be measured by a stadiometer
Time Frame
Change from 12 weeks of intervention to 12 months
Title
Change in Fat mass
Description
Fat mass will be assessed by Dual-energy X-ray Absorptiometry (DXA)
Time Frame
Change from baseline to 12 weeks
Title
Change in fat free mass
Description
Fat free mass will be assessed by Dual-energy X-ray Absorptiometry (DXA)
Time Frame
Change from 12 weeks of intervention to 12 months
Title
Change in waist circumference
Description
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
Title
Change in waist circumference
Description
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 12 weeks of intervention to 12 months
Title
Change in hip circumference
Description
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
Title
Change in hip circumference
Description
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 12 weeks of intervention to 12 months
Title
Change in neck circumference
Description
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
Title
Change in neck circumference
Description
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 12 weeks of intervention to 12 months
Title
Change in systolic blood pressure
Description
Systolic blood pressure will be assessed by blood pressure monitor
Time Frame
Change from baseline to 12 weeks
Title
Change in systolic blood pressure
Description
Systolic blood pressure will be assessed by blood pressure monitor
Time Frame
Change from 12 weeks of intervention to 12 months
Title
Change in diastolic blood pressure
Description
Diastolic blood pressure will be assessed by blood pressure monitor
Time Frame
Change from baseline to 12 weeks
Title
Change in diastolic blood pressure
Description
Diastolic blood pressure will be assessed by blood pressure monitor
Time Frame
Change from 12 weeks of intervention to 12 months
Title
Change in energy intake
Description
Energy intake (kcal/day) will be assessed by 24h recalls
Time Frame
Change from baseline to 12 weeks
Title
Change in carbohydrates intake
Description
Macronutrients intake (g/day and percentage of energy intake) will be assessed by 24h recalls
Time Frame
Change from baseline to 12 weeks
Title
Change in fat intake
Description
Fat intake (g/day and percentage of energy intake) will be assessed by 24h recalls
Time Frame
Change from baseline to 12 weeks
Title
Change in protein intake
Description
Protein intake (g/day and percentage of energy intake) will be assessed by 24h recalls
Time Frame
Change from baseline to 12 weeks
Title
Change in dietary habits
Description
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
Title
Change in Appetite traits
Description
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
Title
Change in Subjective sleep quality
Description
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
Title
Change in Objectively sleep quality
Description
Objectively sleep quality will be assessed by accelerometry
Time Frame
Change from baseline to 12 weeks
Title
Change in Chronotype
Description
Chronotype will be assessed by the Munich Chronotype Questionnaire (MCTQ).
Time Frame
Change from baseline to 12 weeks
Title
Change in Morning-Evening type
Description
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
Title
Change Objectively moderate to vigorous physical activity levels
Description
Objectively physical activity levels will be assessed by accelerometry
Time Frame
Change from baseline to 12 weeks
Title
Change in Depression aspects
Description
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
Title
Change in Stress aspects
Description
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
Title
Change in Anxiety aspects
Description
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
Title
Change in General health
Description
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
Title
Change in Quality of life
Description
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
Title
Change in Gut microbiota composition
Description
DNA sequencing to determine gut microbiota composition (e.g., phylum and genera)
Time Frame
Change from baseline to 12 weeks
Title
Change in Gut microbiota diversity
Description
DNA sequencing to determine gut microbiota diversity (e.g., beta and alpha)
Time Frame
Change from baseline to 12 weeks
Title
Change in Cardiorespiratory Fitness
Description
Cardiorespiratory fitness measured by maximum treadmill test
Time Frame
Change from baseline to 12 weeks
Title
Change in Lower muscular strength
Description
Lower body muscular strength measured by chair stand test.
Time Frame
Change from baseline to 12 weeks
Title
Change in Upper muscular strength
Description
Upper body muscular strength measured by hand grip strength test.
Time Frame
Change from baseline to 12 weeks
Title
Change in walking speed.
Description
Walking speed measured by gait speed test. Higher values mean worse performance.
Time Frame
Change from baseline to 12 weeks
Title
Adherence to the time-restricted eating intervention
Description
Adherence will be assessed by eating records through the mobile phone app.
Time Frame
Change from baseline to 12 weeks
Title
Adherence to the exercise intervention
Description
Adherence will be assessed by number of completed exercise sessions.
Time Frame
Change from baseline to 12 weeks
Title
Change in hepatic fat content
Description
Hepatic fat content will be assessed by Magnetic Resonance Imaging (MRI)
Time Frame
Change from 12 weeks of intervention to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonatan R. Ruiz, PhD
Phone
0034958242754
Email
ruizj@ugr.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonatan R. Ruiz, PhD
Organizational Affiliation
Universidad de Granada
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Granada - Instituto Mixto Universitario Deporte y Salud
City
Granada
ZIP/Postal Code
18011
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonatan R Ruiz, PhD
Phone
0034958242754
Email
ruizj@ugr.es
First Name & Middle Initial & Last Name & Degree
Jonatan M Ruiz, PhD
Facility Name
University of Granada
City
Granada
ZIP/Postal Code
18011
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonatan R Ruiz, PhD
Phone
0034958242754
Email
ruizj@ugr.es
First Name & Middle Initial & Last Name & Degree
Jonatan R Ruiz, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Time-Restricted Eating, Exercise and Cardiometabolic Health in Obesity
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