Skip to main content
OpenTrials
Completed

NCT Number: NCT05897073

Time-Restricted Eating, Exercise and Cardiometabolic Health in Obesity

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Time Restricted Feeding Behavior Body Weight Cardiometabolic Syndrome Digestive System Diseases Exercise Fasting Fatty Liver Feeding Behavior Glucose Metabolism Disorders Hepatic Steatosis Hyperinsulinism Insulin Resistance Intermittent Fasting Liver Diseases Metabolic Diseases Metabolic Syndrome Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Granada, Granada, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in hepatic fat content

    Time frame: Change from baseline to 12 weeks

    Hepatic fat content will be assessed by Magnetic Resonance Imaging (MRI)

Secondary outcomes

  1. Change in liver stiffness

    Time frame: Change from baseline to 12 weeks

    The quantification of stiffness will be assessed using attenuation imaging, shear wave elastography and shear wave dispersion with a Canon Aplio i800.

  2. Change in values of alkaline phosphatase

    Time frame: Change from baseline to 12 weeks

    Fasting blood samples will be used to asses alkaline phosphatase

  3. Change in values of alanine transaminase

    Time frame: Change from baseline to 12 weeks

    Fasting blood samples will be used to asses alanine transaminase

  4. Change in values of gamma-glutamyl transferase

    Time frame: Change from baseline to 12 weeks

    Fasting blood samples will be used to assess gamma-glutamyl transferase

  5. Change in visceral adipose tissue

    Time frame: Change from baseline to 12 weeks

    Visceral adipose tissue will be assessed by Magnetic Resonance Imaging (MRI)

  6. Change in abdominal subcutaneous adipose tissue

    Time frame: Change from baseline to 12 weeks

    Abdominal subcutaneous adipose tissue will be assessed by Magnetic Resonance Imaging (MRI)

  7. Change in visceral adipose tissue

    Time frame: Change from baseline to 12 months

    Visceral adipose tissue will be assessed by Magnetic Resonance Imaging (MRI)

  8. Change in abdominal subcutaneous adipose tissue

    Time frame: Change from baseline to 12 months

    Abdominal subcutaneous adipose tissue will be assessed by Magnetic Resonance Imaging (MRI)

  9. Change in pancreatic fat content

    Time frame: Change from baseline to 12 weeks

    Pancreatic fat content will be assessed by Magnetic Resonance Imaging (MRI)

  10. Change in pancreatic fat content

    Time frame: Change from baseline to 12 months

    Pancreatic fat content will be assessed by Magnetic Resonance Imaging (MRI)

  11. Change in values of fasting glucose

    Time frame: Change from baseline to 12 weeks

    Fasting blood samples will be used to assess glucose

  12. Change in HOMA-IR index.

    Time frame: Change from baseline to 12 weeks

    Fasting blood samples will be used to assess glucose and insulin and HOMA index will be computed

  13. Change in values of HbA1c

    Time frame: Change from baseline to 12 weeks

    Fasting blood samples will be used to assess HbA1c

  14. Change in values of fasting triglycerides

    Time frame: Change from baseline to 12 weeks

    Fasting blood samples will be used to assess levels of triglycerides

  15. Change in values of fasting high-density lipoprotein cholesterol

    Time frame: Change from baseline to 12 weeks

    Fasting blood samples will be used to assess levels of high-density lipoprotein cholesterol

  16. Change in values of fasting low-density lipoprotein cholesterol

    Time frame: Change from baseline to 12 weeks

    Fasting blood samples will be used to assess levels of low-density lipoprotein cholesterol

  17. Change in values of fasting total cholesterol

    Time frame: Change from baseline to 12 weeks

    Fasting blood samples will be used to assess levels of total cholesterol

  18. Change in values of C-reactive protein

    Time frame: Change from baseline to 12 weeks

    Fasting blood samples will be used to assess levels of C-reactive protein

  19. Change in values of interleukin 6

    Time frame: Change from baseline to 12 weeks

    Fasting blood samples will be used to assess levels of interleukin 6

  20. Change in values of apolipoprotein A1

    Time frame: Change from baseline to 12 weeks

    Fasting blood samples will be used to assess levels of apolipoprotein A1

  21. Change in values of apolipoprotein B

    Time frame: Change from baseline to 12 weeks

    Fasting blood samples will be used to assess levels of apolipoprotein B

  22. Change in levels of mean glucose (Continuous Glucose Monitoring)

    Time frame: Change from baseline to the last 2 weeks of intervention

    24-hour, diurnal and nocturnal mean glucose over 14 days will be assessed by Continuous Glucose Monitoring during 2 weeks

  23. Change in 2-hour plasma glucose

    Time frame: Change in 2-hour plasma glucose baseline and 12 weeks

    2-hour plasma glucose will be assessed by oral glucose tolerance test.

  24. Change in Body weight

    Time frame: Change from baseline to 12 weeks

    Body weight will be measured by a digital scale

  25. Change in Body weight

    Time frame: Change from baseline to 12 months

    Body weight will be measured by a digital scale

  26. Change in Body height

    Time frame: Change from baseline to 12 weeks

    Body height will be measured by a stadiometer

  27. Change in Body height

    Time frame: Change from baseline to 12 months

    Body height will be measured by a stadiometer

  28. Change in waist circumference

    Time frame: Change from baseline to 12 weeks

    Waist circumference will be assessed by measuring tape following the procedures outlined by the International Society for the Advancement of Kinanthropometry

  29. Change in calf girth

    Time frame: Change from baseline to 12 weeks

    Calf girth will be assessed by measuring tape following the procedures outlined by the International Society for the Advancement of Kinanthropometry

  30. Change in waist circumference

    Time frame: Change from baseline to 12 months

    Waist circumference will be assessed by measuring tape following the procedures outlined by the International Society for the Advancement of Kinanthropometry

  31. Change in calf girth

    Time frame: Change from baseline to 12 months

    Calf girth will be assessed by measuring tape following the procedures outlined by the International Society for the Advancement of Kinanthropometry

  32. Change in hip circumference

    Time frame: Change from baseline to 12 weeks

    Hip circumference will be assessed by measuring tape following the procedures outlined by the International Society for the Advancement of Kinanthropometry

  33. Change in hip circumference

    Time frame: Change from baseline to 12 months

    Hip circumference will be assessed by measuring tape following the procedures outlined by the International Society for the Advancement of Kinanthropometry

  34. Change in neck circumference

    Time frame: Change from baseline to 12 weeks

    Neck circumference will be assessed by measuring tape following the procedures outlined by the International Society for the Advancement of Kinanthropometry

  35. Change in neck circumference

    Time frame: Change from baseline to 12 months

    Neck circumference will be assessed by measuring tape following the procedures outlined by the International Society for the Advancement of Kinanthropometry

  36. Change in systolic blood pressure

    Time frame: Change from baseline to 12 weeks

    Systolic blood pressure will be assessed by blood pressure monitor

  37. Change in systolic blood pressure

    Time frame: Change from baseline to 12 months

    Systolic blood pressure will be assessed by blood pressure monitor

  38. Change in diastolic blood pressure

    Time frame: Change from baseline to 12 weeks

    Diastolic blood pressure will be assessed by blood pressure monitor

  39. Change in diastolic blood pressure

    Time frame: Change from baseline to 12 months

    Diastolic blood pressure will be assessed by blood pressure monitor

  40. Change in energy intake

    Time frame: Change from baseline to 12 weeks

    Energy intake (kcal/day) will be assessed by 24h recalls

  41. Change in carbohydrates intake

    Time frame: Change from baseline to 12 weeks

    Macronutrients intake (g/day and percentage of energy intake) will be assessed by 24h recalls

  42. Change in fat intake

    Time frame: Change from baseline to 12 weeks

    Fat intake (g/day and percentage of energy intake) will be assessed by 24h recalls

  43. Change in protein intake

    Time frame: Change from baseline to 12 weeks

    Protein intake (g/day and percentage of energy intake) will be assessed by 24h recalls

  44. Change in dietary habits

    Time frame: 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.

  45. Change in Appetite traits

    Time frame: 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.

  46. Change in Subjective sleep quality

    Time frame: 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.

  47. Change in Objectively sleep quality

    Time frame: Change from baseline to 12 weeks

    Objectively sleep quality will be assessed by accelerometry

  48. Change in Chronotype

    Time frame: Change from baseline to 12 weeks

    Chronotype will be assessed by the Munich Chronotype Questionnaire (MCTQ).

  49. Change in Morning-Evening type

    Time frame: 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.

  50. Change Objectively moderate to vigorous physical activity levels

    Time frame: Change from baseline to 12 weeks

    Objectively physical activity levels will be assessed by accelerometry

  51. Change in Depression aspects

    Time frame: 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.

  52. Change in Stress aspects

    Time frame: 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.

  53. Change in Anxiety aspects

    Time frame: 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.

  54. Change in General health

    Time frame: 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.

  55. Change in Quality of life

    Time frame: 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.

  56. Change in fecal microbiota composition

    Time frame: Change from baseline to 12 weeks

    Shotgun metagenomic sequencing of DNA extracted from stool samples to determine taxonomic profiling (e.g., phylum, genera, species).

  57. Change in fecal microbiota diversity

    Time frame: Change from baseline to 12 weeks

    Shotgun metagenomic sequencing of DNA extracted from stool samples to determine fecal microbiota diversity (e.g., beta and alpha diversity metrics).

  58. Change in Cardiorespiratory Fitness

    Time frame: Change from baseline to 12 weeks

    Cardiorespiratory fitness measured by maximum treadmill test

  59. Change in Lower muscular strength

    Time frame: Change from baseline to 12 weeks

    Lower body muscular strength measured by chair stand test.

  60. Change in Upper muscular strength

    Time frame: Change from baseline to 12 weeks

    Upper body muscular strength measured by hand grip strength test.

  61. Change in walking speed.

    Time frame: Change from baseline to 12 weeks

    Walking speed measured by gait speed test. Higher values mean worse performance.

  62. Adherence to the eating window

    Time frame: During the 12 weeks

    Adherence will be assessed by eating records through the mobile phone app.

  63. Attendance to the exercise intervention

    Time frame: During the 12 weeks

    Attendance will be assessed by number of completed exercise sessions.

  64. Change in hepatic fat content

    Time frame: Change from baseline to 12 months

    Hepatic fat content will be assessed by Magnetic Resonance Imaging (MRI)

  65. Change in abdominal intermuscular fat content

    Time frame: Change from baseline to 12 weeks

    Abdominal intermuscular fat content will be assessed by Magnetic Resonance Imaging (MRI)

  66. Change in abdominal intermuscular fat content

    Time frame: Change from baseline to 12 months

    Abdominal intermuscular fat content will be assessed by Magnetic Resonance Imaging (MRI)

  67. Change in abdominal skeletal muscle tissue

    Time frame: Change from baseline to 12 months

    Abdominal skeletal muscle tissue will be assessed by Magnetic Resonance Imaging (MRI)

  68. Change in abdominal skeletal muscle tissue

    Time frame: Change from baseline to 12 weeks

    Abdominal skeletal muscle tissue will be assessed by Magnetic Resonance Imaging (MRI)

  69. Change in mid-thigh subcutaneous adipose tissue

    Time frame: Change from baseline to 12 weeks

    Mid-thigh subcutaneous adipose tissue will be assessed by Magnetic Resonance Imaging (MRI)

  70. Change in mid-thigh subcutaneous adipose tissue

    Time frame: Change from baseline to 12 months

    Mid-thigh subcutaneous adipose tissue will be assessed by Magnetic Resonance Imaging (MRI)

  71. Change in mid-thigh intermuscular fat content

    Time frame: Change from baseline to 12 weeks

    Mid-thigh intermuscular fat content will be assessed by Magnetic Resonance Imaging (MRI)

  72. Change in mid-thigh intermuscular fat content

    Time frame: Change from baseline to 12 months

    Mid-thigh intermuscular fat content will be assessed by Magnetic Resonance Imaging (MRI)

  73. Change in mid-thigh intramuscular fat content

    Time frame: Change from baseline to 12 weeks

    Mid-thigh intramuscular fat content will be assessed by Magnetic Resonance Imaging (MRI)

  74. Change in mid-thigh intramuscular fat content

    Time frame: Change from baseline to 12 months

    Mid-thigh intramuscular fat content will be assessed by Magnetic Resonance Imaging (MRI)

  75. Change in mid-thigh skeletal muscle tissue

    Time frame: Change from baseline to 12 weeks

    Mid-thigh skeletal muscle tissue will be assessed by Magnetic Resonance Imaging (MRI)

  76. Change in mid-thigh skeletal muscle tissue

    Time frame: Change from baseline to 12 months

    Mid-thigh skeletal muscle tissue will be assessed by Magnetic Resonance Imaging (MRI)

  77. Change in liver stiffness

    Time frame: Change from baseline to 12 months

    The quantification of stiffness will be assessed using attenuation imaging, shear wave elastography and shear wave dispersion with a Canon Aplio i800.

  78. Change in liver steatosis

    Time frame: Change from baseline to 12 weeks

    The quantification of steatosis will be assessed using attenuation imaging, shear wave elastography and shear wave dispersion with a Canon Aplio i800.

  79. Change in liver steatosis

    Time frame: Change from baseline to 12 months

    The quantification of steatosis will be assessed using attenuation imaging, shear wave elastography and shear wave dispersion with a Canon Aplio i800.

  80. Change in liver viscosity

    Time frame: Change from baseline to 12 weeks

    The quantification of viscosity will be assessed using attenuation imaging, shear wave elastography and shear wave dispersion with a Canon Aplio i800.

  81. Change in liver viscosity

    Time frame: Change from baseline to 12 months

    The quantification of viscosity will be assessed using attenuation imaging, shear wave elastography and shear wave dispersion with a Canon Aplio i800.

  82. Change in Fat Mass

    Time frame: Change from baseline to 12 weeks

    Fat mass will be assessed by assessed by bioelectrical impedance analysis (BIA).

  83. Change in Fat Mass

    Time frame: Change from baseline to 12 months

    Fat mass will be assessed by assessed by bioelectrical impedance analysis (BIA).

  84. Change in Fat-free Mass

    Time frame: Change from baseline to 12 weeks

    Fat-free mass will be assessed by assessed by bioelectrical impedance analysis (BIA).

  85. Change in Fat-free Mass

    Time frame: Change from baseline to 12 months

    Fat-free mass will be assessed by assessed by bioelectrical impedance analysis (BIA).

  86. Change in Bone Mineral Density

    Time frame: Change from baseline to 12 months

    Bone mineral density will be assessed by dual-energy X-ray absorptiometry scans (DXA).

  87. Change in Bone Mineral Density

    Time frame: Change from baseline to 12 weeks

    Bone mineral density will be assessed by dual-energy X-ray absorptiometry scans (DXA).

  88. Change in values of alkaline phosphatase

    Time frame: Change from baseline to 12 months

    Fasting blood samples will be used to asses alkaline phosphatase

  89. Change in values of alanine transaminase

    Time frame: Change from baseline to 12 months

    Fasting blood samples will be used to asses alanine transaminase

  90. Change in values of aspartate aminotransferase

    Time frame: Change from baseline to 12 weeks

    Fasting blood samples will be used to asses aspartate aminotransferase

  91. Change in values of aspartate aminotransferase

    Time frame: Change from baseline to 12 months

    Fasting blood samples will be used to asses aspartate aminotransferase

  92. Change in values of gamma-glutamyl transferase

    Time frame: Change from baseline to 12 months

    Fasting blood samples will be used to assess gamma-glutamyl transferase

  93. Change in values of HbA1c

    Time frame: Change from baseline to 12 months

    Fasting blood samples will be used to assess HbA1c

  94. Change in values of fasting glucose

    Time frame: Change from baseline to 12 months

    Fasting blood samples will be used to assess glucose

  95. Change in values of fasting insulin

    Time frame: Change from baseline to 12 weeks

    Fasting blood samples will be used to assess insulin

  96. Change in values of fasting insulin

    Time frame: Change from baseline to 12 months

    Fasting blood samples will be used to assess insulin

  97. Change in HOMA-IR index.

    Time frame: Change from baseline to 12 months

    Fasting blood samples will be used to assess glucose and insulin and HOMA index will be computed

  98. Change in values of fasting triglycerides

    Time frame: Change from baseline to 12 months

    Fasting blood samples will be used to assess levels of triglycerides

  99. Change in values of fasting high-density lipoprotein cholesterol

    Time frame: Change from baseline to 12 months

    Fasting blood samples will be used to assess levels of high-density lipoprotein cholesterol

  100. Change in values of fasting low-density lipoprotein cholesterol

    Time frame: Change from baseline to 12 months

    Fasting blood samples will be used to assess levels of low-density lipoprotein cholesterol

  101. Change in values of fasting total cholesterol

    Time frame: Change from baseline to 12 months

    Fasting blood samples will be used to assess levels of total cholesterol

  102. Change in values of apolipoprotein A1

    Time frame: Change from baseline to 12 months

    Fasting blood samples will be used to assess levels of apolipoprotein A1

  103. Change in values of apolipoprotein B

    Time frame: Change from baseline to 12 months

    Fasting blood samples will be used to assess levels of apolipoprotein B

  104. Change in values of C-reactive protein

    Time frame: Change from baseline to 12 months

    Fasting blood samples will be used to assess levels of C-reactive protein

  105. Change in values of interleukin 6

    Time frame: Change from baseline to 12 months

    Fasting blood samples will be used to assess levels of interleukin 6

  106. Change in values of essential amino acids

    Time frame: Change from baseline to 12 weeks

    Fasting urine samples will be used to assess levels of essential amino acids.

  107. Change in values of non-essential amino acids

    Time frame: Change from baseline to 12 weeks

    Fasting urine samples will be used to assess levels of essential amino acids.

  108. Change in fiber intake

    Time frame: Change from baseline to 12 weeks

    Fiber intake (g/day and percentage of energy intake) will be assessed by 24h recalls

  109. Change in rest-activity rhythms

    Time frame: Change from baseline to the last 2 weeks of intervention

    Rest-activity rhythms will be assessed by accelerometry

  110. Change in steps counts

    Time frame: Change from baseline to the last 2 weeks of intervention

    Steps counts will be assessed by activity band

  111. Change in Fat Mass

    Time frame: Change from baseline to 6 weeks

    Fat mass will be assessed by assessed by bioelectrical impedance analysis (BIA).

  112. Change in Fat-free Mass

    Time frame: Change from baseline to 6 weeks

    Fat-free mass will be assessed by assessed by bioelectrical impedance analysis (BIA).

  113. Change in Body weight

    Time frame: Change from baseline to 6 weeks

    Body weight will be measured by a digital scale

  114. Change in waist circumference

    Time frame: Change from baseline to 6 weeks

    Waist circumference will be assessed by measuring tape following the procedures outlined by the International Society for the Advancement of Kinanthropometry

  115. Change in hip circumference

    Time frame: Change from baseline to 6 weeks

    Hip circumference will be assessed by measuring tape following the procedures outlined by the International Society for the Advancement of Kinanthropometry

  116. Change in neck circumference

    Time frame: Change from baseline to 6 weeks

    Neck circumference will be assessed by measuring tape following the procedures outlined by the International Society for the Advancement of Kinanthropometry

  117. Change in calf girth

    Time frame: Change from baseline to 6 weeks

    Calf girth will be assessed by measuring tape following the procedures outlined by the International Society for the Advancement of Kinanthropometry

  118. Change in Bone Mineral Density

    Time frame: Change from baseline to 6 weeks

    Bone mineral density will be assessed by dual-energy X-ray absorptiometry scans (DXA).

  119. Change in fecal microbiota functionality

    Time frame: Change from baseline to 12 weeks

    Shotgun metagenomic sequencing of DNA extracted from stool samples to determine microbial functional capacity through the analysis of metabolic pathways.

  120. Change in fiber intake

    Time frame: Change from baseline to 6 weeks

    Fiber intake (g/day and percentage of energy intake) will be assessed by 24h recalls

  121. Change in carbohydrates intake

    Time frame: Change from baseline to 6 weeks

    Macronutrients intake (g/day and percentage of energy intake) will be assessed by 24h recalls

  122. Change in protein intake

    Time frame: Change from baseline to 6 weeks

    Protein intake (g/day and percentage of energy intake) will be assessed by 24h recalls

  123. Change in energy intake

    Time frame: Change from baseline to 6 weeks

    Energy intake (kcal/day) will be assessed by 24h recalls

  124. Change in fat intake

    Time frame: Change from baseline to 6 weeks

    Fat intake (g/day and percentage of energy intake) will be assessed by 24h recalls

  125. Change in adherence to Mediterranean diet

    Time frame: Change from baseline to 6 weeks

    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.

  126. Change in adherence to Mediterranean diet

    Time frame: Change from baseline to 12 weeks

    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.

  127. Change in adherence to Mediterranean diet

    Time frame: Change from baseline to 12 months

    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.

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Registry information

Official study title

Impact of Time-Restricted Eating and Supervised Exercise on Hepatic Steatosis and Cardiometabolic Health in Adults With Obesity

Acronym: TEMPUS

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jun 9, 2023
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.