Time-Restricted Eating, Exercise and Cardiometabolic Health in Obesity

Not Applicable

Completed

• Conditions: Exercise; Hepatic Steatosis; Cardiometabolic Syndrome; Obesity; Time Restricted Feeding

• 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

Study Timeline

• Study Start: 2023-05-02
• Study First Submitted: 2023-05-05
• Study First Submitted QC: 2023-05-31
• Study First Posted: 2023-06-09
• Status Verified: 2025-09
• Primary Completion: 2025-09-05
• Study Completion: 2025-09-05
• Last Update Submitted: 2025-09-17
• Last Update Posted: 2025-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 187

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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 liver stiffness	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.
Change in values of alkaline phosphatase	Change from baseline to 12 months	Fasting blood samples will be used to asses alkaline phosphatase
Change in values of alanine transaminase	Change from baseline to 12 months	Fasting blood samples will be used to asses alanine transaminase
Change in visceral adipose tissue	Change from baseline to 12 months	Visceral adipose tissue will be assessed by Magnetic Resonance Imaging (MRI)
Change in values of gamma-glutamyl transferase	Change from baseline to 12 months	Fasting blood samples will be used to assess gamma-glutamyl transferase
Change in abdominal subcutaneous adipose tissue	Change from baseline to 12 months	Abdominal subcutaneous adipose tissue will be assessed by Magnetic Resonance Imaging (MRI)
Change in pancreatic fat content	Change from baseline to 12 months	Pancreatic fat content will be assessed by Magnetic Resonance Imaging (MRI)
Change in values of fasting glucose	Change from baseline to 12 months	Fasting blood samples will be used to assess glucose
Change in HOMA-IR index.	Change from baseline to 12 months	Fasting blood samples will be used to assess glucose and insulin and HOMA index will be computed
Change in values of HbA1c	Change from baseline to 12 months	Fasting blood samples will be used to assess HbA1c
Change in values of fasting high-density lipoprotein cholesterol	Change from baseline to 12 months	Fasting blood samples will be used to assess levels of high-density lipoprotein cholesterol
Change in values of fasting triglycerides	Change from baseline to 12 months	Fasting blood samples will be used to assess levels of triglycerides
Change in values of fasting low-density lipoprotein cholesterol	Change from baseline to 12 months	Fasting blood samples will be used to assess levels of low-density lipoprotein cholesterol
Change in values of fasting total cholesterol	Change from baseline to 12 months	Fasting blood samples will be used to assess levels of total cholesterol
Change in values of C-reactive protein	Change from baseline to 12 months	Fasting blood samples will be used to assess levels of C-reactive protein
Change in values of interleukin 6	Change from baseline to 12 months	Fasting blood samples will be used to assess levels of interleukin 6
Change in values of apolipoprotein A1	Change from baseline to 12 months	Fasting blood samples will be used to assess levels of apolipoprotein A1
Change in values of apolipoprotein B	Change from baseline to 12 months	Fasting blood samples will be used to assess levels of apolipoprotein B
Change in Body weight	Change from baseline to 6 weeks	Body weight will be measured by a digital scale
Change in levels of mean glucose (Continuous Glucose Monitoring)	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
Change in 2-hour plasma glucose	Change in 2-hour plasma glucose baseline and 12 weeks	2-hour plasma glucose will be assessed by oral glucose tolerance test.
Change in Body height	Change from baseline to 12 months	Body height will be measured by a stadiometer
Change in waist circumference	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
Change in calf girth	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
Change in diastolic blood pressure	Change from baseline to 12 months	Diastolic blood pressure will be assessed by blood pressure monitor
Change in hip circumference	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
Change in neck circumference	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
Change in systolic blood pressure	Change from baseline to 12 months	Systolic blood pressure will be assessed by blood pressure monitor
Change in energy intake	Change from baseline to 6 weeks	Energy intake (kcal/day) will be assessed by 24h recalls
Change in carbohydrates intake	Change from baseline to 6 weeks	Macronutrients 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 fat intake	Change from baseline to 6 weeks	Fat intake (g/day and percentage of energy intake) will be assessed by 24h recalls
Change in protein intake	Change from baseline to 6 weeks	Protein intake (g/day and percentage of energy intake) will be assessed by 24h recalls
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 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 Chronotype	Change from baseline to 12 weeks	Chronotype will be assessed by the Munich Chronotype Questionnaire (MCTQ).
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 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 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 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.
Change in Cardiorespiratory Fitness	Change from baseline to 12 weeks	Cardiorespiratory fitness measured by maximum treadmill test
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 fecal microbiota composition	Change from baseline to 12 weeks	Shotgun metagenomic sequencing of DNA extracted from stool samples to determine taxonomic profiling (e.g., phylum, genera, species).
Change in mid-thigh intermuscular fat content	Change from baseline to 12 months	Mid-thigh intermuscular fat content will be assessed by Magnetic Resonance Imaging (MRI)
Change in values of aspartate aminotransferase	Change from baseline to 12 months	Fasting blood samples will be used to asses aspartate aminotransferase
Change in fecal microbiota diversity	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).
Adherence to the eating window	During the 12 weeks	Adherence will be assessed by eating records through the mobile phone app.
Attendance to the exercise intervention	During the 12 weeks	Attendance will be assessed by number of completed exercise sessions.
Change in Lower muscular strength	Change from baseline to 12 weeks	Lower body muscular strength measured by chair stand test.
Change in Upper muscular strength	Change from baseline to 12 weeks	Upper body muscular strength measured by hand grip strength 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 baseline to 12 months	Hepatic fat content will be assessed by Magnetic Resonance Imaging (MRI)
Change in abdominal intermuscular fat content	Change from baseline to 12 months	Abdominal intermuscular fat content will be assessed by Magnetic Resonance Imaging (MRI)
Change in abdominal skeletal muscle tissue	Change from baseline to 12 weeks	Abdominal skeletal muscle tissue will be assessed by Magnetic Resonance Imaging (MRI)
Change in mid-thigh subcutaneous adipose tissue	Change from baseline to 12 months	Mid-thigh subcutaneous adipose tissue will be assessed by Magnetic Resonance Imaging (MRI)
Change in Fat Mass	Change from baseline to 6 weeks	Fat mass will be assessed by assessed by bioelectrical impedance analysis (BIA).
Change in values of non-essential amino acids	Change from baseline to 12 weeks	Fasting urine samples will be used to assess levels of essential amino acids.
Change in mid-thigh intramuscular fat content	Change from baseline to 12 months	Mid-thigh intramuscular fat content will be assessed by Magnetic Resonance Imaging (MRI)
Change in values of essential amino acids	Change from baseline to 12 weeks	Fasting urine samples will be used to assess levels of essential amino acids.
Change in steps counts	Change from baseline to the last 2 weeks of intervention	Steps counts will be assessed by activity band
Change in fecal microbiota functionality	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.
Change in mid-thigh skeletal muscle tissue	Change from baseline to 12 months	Mid-thigh skeletal muscle tissue will be assessed by Magnetic Resonance Imaging (MRI)
Change in liver steatosis	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.
Change in liver viscosity	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.
Change in Fat-free Mass	Change from baseline to 6 weeks	Fat-free mass will be assessed by assessed by bioelectrical impedance analysis (BIA).
Change in Bone Mineral Density	Change from baseline to 6 weeks	Bone mineral density will be assessed by dual-energy X-ray absorptiometry scans (DXA).
Change in rest-activity rhythms	Change from baseline to the last 2 weeks of intervention	Rest-activity rhythms will be assessed by accelerometry
Change in values of fasting insulin	Change from baseline to 12 months	Fasting blood samples will be used to assess insulin
Change in fiber intake	Change from baseline to 6 weeks	Fiber intake (g/day and percentage of energy intake) will be assessed by 24h recalls
Change in adherence to Mediterranean diet	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.

Trial Locations

Locations (2)

University of Granada - Instituto Mixto Universitario Deporte y Salud; 🇪🇸 Granada, Spain

University of Granada; 🇪🇸 Granada, Spain