Time Restricted FeedingTEMPUSNCT05897073

Time-Restricted Eating, Exercise and Cardiometabolic Health in Obesity

A study testing Time-restricted eating intervention, Exercise intervention and Time-restricted eating plus exercise intervention in people with Time Restricted Feeding and Exercise, run by Universidad de Granada at 2 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 25 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Time Restricted Feeding, Exercise, Hepatic Steatosis
What is being tested?: Time-restricted eating intervention, Exercise intervention and Time-restricted eating plus exercise intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 187 participants
Where: 2 sitesSpain
Study dates: 2 May 2023to 5 Sep 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 25 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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).

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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.

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

University of Granada - Instituto Mixto Universitario Deporte y Salud
Granada, Granada, 18011
University of Granada
Granada, Granada, 18011

Other trials in Spain

About this study

Official title: Impact of Time-Restricted Eating and Supervised Exercise on Hepatic Steatosis and Cardiometabolic Health in Adults With 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.

Conditions: Time Restricted Feeding, Exercise, Hepatic Steatosis, Cardiometabolic Syndrome, Obesity
Being tested: Time-restricted eating intervention, Exercise intervention, Time-restricted eating plus exercise intervention
Medical subject headings: Intermittent Fasting, Motor Activity, Fatty Liver, Metabolic Syndrome, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Time-restricted eating interventionBehavioural
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 interventionBehavioural
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 interventionBehavioural
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.

Study groups in NCT05897073
Study group	Role	What they receive
Time-restricted eating intervention	Experimental	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. Receives: Behavioral: Time-restricted eating intervention
Supervised exercise intervention	Experimental	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. Receives: Behavioral: Exercise intervention
Usual-care control group	No intervention	Participants will receive standard recommendations on healthy lifestyle based on Mediterranean dietary pattern and physical activity recommendations for weight loss and health promotion.
Time-restricted eating plus Supervised exercise	Experimental	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- Receives: Behavioral: Time-restricted eating plus exercise intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in hepatic fat content
Hepatic fat content will be assessed by Magnetic Resonance Imaging (MRI)
Measured: Change from baseline to 12 weeks

Secondary outcomes (127)

Change in liver stiffness
The quantification of stiffness will be assessed using attenuation imaging, shear wave elastography and shear wave dispersion with a Canon Aplio i800.
Measured: Change from baseline to 12 weeks
Change in values of alkaline phosphatase
Fasting blood samples will be used to asses alkaline phosphatase
Measured: Change from baseline to 12 weeks
Change in values of alanine transaminase
Fasting blood samples will be used to asses alanine transaminase
Measured: Change from baseline to 12 weeks
Change in values of gamma-glutamyl transferase
Fasting blood samples will be used to assess gamma-glutamyl transferase
Measured: Change from baseline to 12 weeks
Change in visceral adipose tissue
Visceral adipose tissue will be assessed by Magnetic Resonance Imaging (MRI)
Measured: Change from baseline to 12 weeks
Change in abdominal subcutaneous adipose tissue
Abdominal subcutaneous adipose tissue will be assessed by Magnetic Resonance Imaging (MRI)
Measured: Change from baseline to 12 weeks
Change in visceral adipose tissue
Visceral adipose tissue will be assessed by Magnetic Resonance Imaging (MRI)
Measured: Change from baseline to 12 months
Change in abdominal subcutaneous adipose tissue
Abdominal subcutaneous adipose tissue will be assessed by Magnetic Resonance Imaging (MRI)
Measured: Change from baseline to 12 months
Change in pancreatic fat content
Pancreatic fat content will be assessed by Magnetic Resonance Imaging (MRI)
Measured: Change from baseline to 12 weeks
Change in pancreatic fat content
Pancreatic fat content will be assessed by Magnetic Resonance Imaging (MRI)
Measured: Change from baseline to 12 months
Change in values of fasting glucose
Fasting blood samples will be used to assess glucose
Measured: Change from baseline to 12 weeks
Change in HOMA-IR index.
Fasting blood samples will be used to assess glucose and insulin and HOMA index will be computed
Measured: Change from baseline to 12 weeks
Change in values of HbA1c
Fasting blood samples will be used to assess HbA1c
Measured: Change from baseline to 12 weeks
Change in values of fasting triglycerides
Fasting blood samples will be used to assess levels of triglycerides
Measured: Change from baseline to 12 weeks
Change in values of fasting high-density lipoprotein cholesterol
Fasting blood samples will be used to assess levels of high-density lipoprotein cholesterol
Measured: Change from baseline to 12 weeks
Change in values of fasting low-density lipoprotein cholesterol
Fasting blood samples will be used to assess levels of low-density lipoprotein cholesterol
Measured: Change from baseline to 12 weeks
Change in values of fasting total cholesterol
Fasting blood samples will be used to assess levels of total cholesterol
Measured: Change from baseline to 12 weeks
Change in values of C-reactive protein
Fasting blood samples will be used to assess levels of C-reactive protein
Measured: Change from baseline to 12 weeks
Change in values of interleukin 6
Fasting blood samples will be used to assess levels of interleukin 6
Measured: Change from baseline to 12 weeks
Change in values of apolipoprotein A1
Fasting blood samples will be used to assess levels of apolipoprotein A1
Measured: Change from baseline to 12 weeks
Change in values of apolipoprotein B
Fasting blood samples will be used to assess levels of apolipoprotein B
Measured: Change from baseline to 12 weeks
Change in levels of mean glucose (Continuous Glucose Monitoring)
24-hour, diurnal and nocturnal mean glucose over 14 days will be assessed by Continuous Glucose Monitoring during 2 weeks
Measured: Change from baseline to the last 2 weeks of intervention
Change in 2-hour plasma glucose
2-hour plasma glucose will be assessed by oral glucose tolerance test.
Measured: Change in 2-hour plasma glucose baseline and 12 weeks
Change in Body weight
Body weight will be measured by a digital scale
Measured: Change from baseline to 12 weeks
Change in Body weight
Body weight will be measured by a digital scale
Measured: Change from baseline to 12 months
Change in Body height
Body height will be measured by a stadiometer
Measured: Change from baseline to 12 weeks
Change in Body height
Body height will be measured by a stadiometer
Measured: Change from baseline to 12 months
Change in waist circumference
Waist circumference will be assessed by measuring tape following the procedures outlined by the International Society for the Advancement of Kinanthropometry
Measured: Change from baseline to 12 weeks
Change in calf girth
Calf girth will be assessed by measuring tape following the procedures outlined by the International Society for the Advancement of Kinanthropometry
Measured: Change from baseline to 12 weeks
Change in waist circumference
Waist circumference will be assessed by measuring tape following the procedures outlined by the International Society for the Advancement of Kinanthropometry
Measured: Change from baseline to 12 months
Change in calf girth
Calf girth will be assessed by measuring tape following the procedures outlined by the International Society for the Advancement of Kinanthropometry
Measured: Change from baseline to 12 months
Change in hip circumference
Hip circumference will be assessed by measuring tape following the procedures outlined by the International Society for the Advancement of Kinanthropometry
Measured: Change from baseline to 12 weeks
Change in hip circumference
Hip circumference will be assessed by measuring tape following the procedures outlined by the International Society for the Advancement of Kinanthropometry
Measured: Change from baseline to 12 months
Change in neck circumference
Neck circumference will be assessed by measuring tape following the procedures outlined by the International Society for the Advancement of Kinanthropometry
Measured: Change from baseline to 12 weeks
Change in neck circumference
Neck circumference will be assessed by measuring tape following the procedures outlined by the International Society for the Advancement of Kinanthropometry
Measured: Change from baseline to 12 months
Change in systolic blood pressure
Systolic blood pressure will be assessed by blood pressure monitor
Measured: Change from baseline to 12 weeks
Change in systolic blood pressure
Systolic blood pressure will be assessed by blood pressure monitor
Measured: Change from baseline to 12 months
Change in diastolic blood pressure
Diastolic blood pressure will be assessed by blood pressure monitor
Measured: Change from baseline to 12 weeks
Change in diastolic blood pressure
Diastolic blood pressure will be assessed by blood pressure monitor
Measured: Change from baseline to 12 months
Change in energy intake
Energy intake (kcal/day) will be assessed by 24h recalls
Measured: Change from baseline to 12 weeks
Change in carbohydrates intake
Macronutrients intake (g/day and percentage of energy intake) will be assessed by 24h recalls
Measured: Change from baseline to 12 weeks
Change in fat intake
Fat intake (g/day and percentage of energy intake) will be assessed by 24h recalls
Measured: Change from baseline to 12 weeks
Change in protein intake
Protein intake (g/day and percentage of energy intake) will be assessed by 24h recalls
Measured: Change from baseline to 12 weeks
Change in dietary habits
Dietary habits will be assessed by food frequency questionnaire (FFQ). Minimum value is 1 (never) and maximum value is 9 (more than 6 times per day). Higher values mean a more frequency of a certain food consumption.
Measured: Change from baseline to 12 weeks
Change in Appetite traits
Appetite traits will be assessed by the Adult Eating Behavior Questionnaire (AEBQ). Minimum value is 1 (completely disagree) and maximum value is 5 (completely agree). Higher values mean a worse outcome.
Measured: Change from baseline to 12 weeks
Change in Subjective sleep quality
Subjective sleep quality will be assessed by the Pittsburgh Sleep Quality Index (PSQI). Minimum value is 0 (never) and maximum value is 3 (3 or more times per week). Higher values mean a worse outcome.
Measured: Change from baseline to 12 weeks
Change in Objectively sleep quality
Objectively sleep quality will be assessed by accelerometry
Measured: Change from baseline to 12 weeks
Change in Chronotype
Chronotype will be assessed by the Munich Chronotype Questionnaire (MCTQ).
Measured: Change from baseline to 12 weeks
Change in Morning-Evening type
Morning-Evening type will be assessed by the Morningness-Eveningness Questionnaire Self-Assessment Version. Define if a person is more morningness or eveningness based on daily times preferences.
Measured: Change from baseline to 12 weeks
Change Objectively moderate to vigorous physical activity levels
Objectively physical activity levels will be assessed by accelerometry
Measured: Change from baseline to 12 weeks
Change in Depression aspects
Depression aspects will be assessed by the Beck Depression Inventory Fast Screen (BDI-FS). Values ranged from 0 to 63. Higher values mean worse outcome.
Measured: Change from baseline to 12 weeks
Change in Stress aspects
Stress aspects will be assessed by the Perceived Stress Scale (PSS). Values ranged from 0 to 40. Higher values mean worse outcome.
Measured: Change from baseline to 12 weeks
Change in Anxiety aspects
Anxiety aspects will be assessed by the State-Trait Anxiety Inventory (STAI). Values ranged from 0 to 60. Higher values mean worse outcome.
Measured: Change from baseline to 12 weeks
Change in General health
General health will be assessed by the EuroQol 5 dimensions 5 levels (EQ-5D-5L). Values ranged from 0 to 100. Higher values mean better outcome.
Measured: Change from baseline to 12 weeks
Change in Quality of life
Quality of life will be assessed by the Rand Short Form 36 (SF-36). Values ranged from 0 to 100. Higher values mean better outcome.
Measured: Change from baseline to 12 weeks
Change in fecal microbiota composition
Shotgun metagenomic sequencing of DNA extracted from stool samples to determine taxonomic profiling (e.g., phylum, genera, species).
Measured: Change from baseline to 12 weeks
Change in fecal microbiota diversity
Shotgun metagenomic sequencing of DNA extracted from stool samples to determine fecal microbiota diversity (e.g., beta and alpha diversity metrics).
Measured: Change from baseline to 12 weeks
Change in Cardiorespiratory Fitness
Cardiorespiratory fitness measured by maximum treadmill test
Measured: Change from baseline to 12 weeks
Change in Lower muscular strength
Lower body muscular strength measured by chair stand test.
Measured: Change from baseline to 12 weeks
Change in Upper muscular strength
Upper body muscular strength measured by hand grip strength test.
Measured: Change from baseline to 12 weeks
Change in walking speed.
Walking speed measured by gait speed test. Higher values mean worse performance.
Measured: Change from baseline to 12 weeks
Adherence to the eating window
Adherence will be assessed by eating records through the mobile phone app.
Measured: During the 12 weeks
Attendance to the exercise intervention
Attendance will be assessed by number of completed exercise sessions.
Measured: During the 12 weeks
Change in hepatic fat content
Hepatic fat content will be assessed by Magnetic Resonance Imaging (MRI)
Measured: Change from baseline to 12 months
Change in abdominal intermuscular fat content
Abdominal intermuscular fat content will be assessed by Magnetic Resonance Imaging (MRI)
Measured: Change from baseline to 12 weeks
Change in abdominal intermuscular fat content
Abdominal intermuscular fat content will be assessed by Magnetic Resonance Imaging (MRI)
Measured: Change from baseline to 12 months
Change in abdominal skeletal muscle tissue
Abdominal skeletal muscle tissue will be assessed by Magnetic Resonance Imaging (MRI)
Measured: Change from baseline to 12 months
Change in abdominal skeletal muscle tissue
Abdominal skeletal muscle tissue will be assessed by Magnetic Resonance Imaging (MRI)
Measured: Change from baseline to 12 weeks
Change in mid-thigh subcutaneous adipose tissue
Mid-thigh subcutaneous adipose tissue will be assessed by Magnetic Resonance Imaging (MRI)
Measured: Change from baseline to 12 weeks
Change in mid-thigh subcutaneous adipose tissue
Mid-thigh subcutaneous adipose tissue will be assessed by Magnetic Resonance Imaging (MRI)
Measured: Change from baseline to 12 months
Change in mid-thigh intermuscular fat content
Mid-thigh intermuscular fat content will be assessed by Magnetic Resonance Imaging (MRI)
Measured: Change from baseline to 12 weeks
Change in mid-thigh intermuscular fat content
Mid-thigh intermuscular fat content will be assessed by Magnetic Resonance Imaging (MRI)
Measured: Change from baseline to 12 months
Change in mid-thigh intramuscular fat content
Mid-thigh intramuscular fat content will be assessed by Magnetic Resonance Imaging (MRI)
Measured: Change from baseline to 12 weeks
Change in mid-thigh intramuscular fat content
Mid-thigh intramuscular fat content will be assessed by Magnetic Resonance Imaging (MRI)
Measured: Change from baseline to 12 months
Change in mid-thigh skeletal muscle tissue
Mid-thigh skeletal muscle tissue will be assessed by Magnetic Resonance Imaging (MRI)
Measured: Change from baseline to 12 weeks
Change in mid-thigh skeletal muscle tissue
Mid-thigh skeletal muscle tissue will be assessed by Magnetic Resonance Imaging (MRI)
Measured: Change from baseline to 12 months
Change in liver stiffness
The quantification of stiffness will be assessed using attenuation imaging, shear wave elastography and shear wave dispersion with a Canon Aplio i800.
Measured: Change from baseline to 12 months
Change in liver steatosis
The quantification of steatosis will be assessed using attenuation imaging, shear wave elastography and shear wave dispersion with a Canon Aplio i800.
Measured: Change from baseline to 12 weeks
Change in liver steatosis
The quantification of steatosis will be assessed using attenuation imaging, shear wave elastography and shear wave dispersion with a Canon Aplio i800.
Measured: Change from baseline to 12 months
Change in liver viscosity
The quantification of viscosity will be assessed using attenuation imaging, shear wave elastography and shear wave dispersion with a Canon Aplio i800.
Measured: Change from baseline to 12 weeks
Change in liver viscosity
The quantification of viscosity will be assessed using attenuation imaging, shear wave elastography and shear wave dispersion with a Canon Aplio i800.
Measured: Change from baseline to 12 months
Change in Fat Mass
Fat mass will be assessed by assessed by bioelectrical impedance analysis (BIA).
Measured: Change from baseline to 12 weeks
Change in Fat Mass
Fat mass will be assessed by assessed by bioelectrical impedance analysis (BIA).
Measured: Change from baseline to 12 months
Change in Fat-free Mass
Fat-free mass will be assessed by assessed by bioelectrical impedance analysis (BIA).
Measured: Change from baseline to 12 weeks
Change in Fat-free Mass
Fat-free mass will be assessed by assessed by bioelectrical impedance analysis (BIA).
Measured: Change from baseline to 12 months
Change in Bone Mineral Density
Bone mineral density will be assessed by dual-energy X-ray absorptiometry scans (DXA).
Measured: Change from baseline to 12 months
Change in Bone Mineral Density
Bone mineral density will be assessed by dual-energy X-ray absorptiometry scans (DXA).
Measured: Change from baseline to 12 weeks
Change in values of alkaline phosphatase
Fasting blood samples will be used to asses alkaline phosphatase
Measured: Change from baseline to 12 months
Change in values of alanine transaminase
Fasting blood samples will be used to asses alanine transaminase
Measured: Change from baseline to 12 months
Change in values of aspartate aminotransferase
Fasting blood samples will be used to asses aspartate aminotransferase
Measured: Change from baseline to 12 weeks
Change in values of aspartate aminotransferase
Fasting blood samples will be used to asses aspartate aminotransferase
Measured: Change from baseline to 12 months
Change in values of gamma-glutamyl transferase
Fasting blood samples will be used to assess gamma-glutamyl transferase
Measured: Change from baseline to 12 months
Change in values of HbA1c
Fasting blood samples will be used to assess HbA1c
Measured: Change from baseline to 12 months
Change in values of fasting glucose
Fasting blood samples will be used to assess glucose
Measured: Change from baseline to 12 months
Change in values of fasting insulin
Fasting blood samples will be used to assess insulin
Measured: Change from baseline to 12 weeks
Change in values of fasting insulin
Fasting blood samples will be used to assess insulin
Measured: Change from baseline to 12 months
Change in HOMA-IR index.
Fasting blood samples will be used to assess glucose and insulin and HOMA index will be computed
Measured: Change from baseline to 12 months
Change in values of fasting triglycerides
Fasting blood samples will be used to assess levels of triglycerides
Measured: Change from baseline to 12 months
Change in values of fasting high-density lipoprotein cholesterol
Fasting blood samples will be used to assess levels of high-density lipoprotein cholesterol
Measured: Change from baseline to 12 months
Change in values of fasting low-density lipoprotein cholesterol
Fasting blood samples will be used to assess levels of low-density lipoprotein cholesterol
Measured: Change from baseline to 12 months
Change in values of fasting total cholesterol
Fasting blood samples will be used to assess levels of total cholesterol
Measured: Change from baseline to 12 months
Change in values of apolipoprotein A1
Fasting blood samples will be used to assess levels of apolipoprotein A1
Measured: Change from baseline to 12 months
Change in values of apolipoprotein B
Fasting blood samples will be used to assess levels of apolipoprotein B
Measured: Change from baseline to 12 months
Change in values of C-reactive protein
Fasting blood samples will be used to assess levels of C-reactive protein
Measured: Change from baseline to 12 months
Change in values of interleukin 6
Fasting blood samples will be used to assess levels of interleukin 6
Measured: Change from baseline to 12 months
Change in values of essential amino acids
Fasting urine samples will be used to assess levels of essential amino acids.
Measured: Change from baseline to 12 weeks
Change in values of non-essential amino acids
Fasting urine samples will be used to assess levels of essential amino acids.
Measured: Change from baseline to 12 weeks
Change in fiber intake
Fiber intake (g/day and percentage of energy intake) will be assessed by 24h recalls
Measured: Change from baseline to 12 weeks
Change in rest-activity rhythms
Rest-activity rhythms will be assessed by accelerometry
Measured: Change from baseline to the last 2 weeks of intervention
Change in steps counts
Steps counts will be assessed by activity band
Measured: Change from baseline to the last 2 weeks of intervention
Change in Fat Mass
Fat mass will be assessed by assessed by bioelectrical impedance analysis (BIA).
Measured: Change from baseline to 6 weeks
Change in Fat-free Mass
Fat-free mass will be assessed by assessed by bioelectrical impedance analysis (BIA).
Measured: Change from baseline to 6 weeks
Change in Body weight
Body weight will be measured by a digital scale
Measured: Change from baseline to 6 weeks
Change in waist circumference
Waist circumference will be assessed by measuring tape following the procedures outlined by the International Society for the Advancement of Kinanthropometry
Measured: Change from baseline to 6 weeks
Change in hip circumference
Hip circumference will be assessed by measuring tape following the procedures outlined by the International Society for the Advancement of Kinanthropometry
Measured: Change from baseline to 6 weeks
Change in neck circumference
Neck circumference will be assessed by measuring tape following the procedures outlined by the International Society for the Advancement of Kinanthropometry
Measured: Change from baseline to 6 weeks
Change in calf girth
Calf girth will be assessed by measuring tape following the procedures outlined by the International Society for the Advancement of Kinanthropometry
Measured: Change from baseline to 6 weeks
Change in Bone Mineral Density
Bone mineral density will be assessed by dual-energy X-ray absorptiometry scans (DXA).
Measured: Change from baseline to 6 weeks
Change in fecal microbiota functionality
Shotgun metagenomic sequencing of DNA extracted from stool samples to determine microbial functional capacity through the analysis of metabolic pathways.
Measured: Change from baseline to 12 weeks
Change in fiber intake
Fiber intake (g/day and percentage of energy intake) will be assessed by 24h recalls
Measured: Change from baseline to 6 weeks
Change in carbohydrates intake
Macronutrients intake (g/day and percentage of energy intake) will be assessed by 24h recalls
Measured: Change from baseline to 6 weeks
Change in protein intake
Protein intake (g/day and percentage of energy intake) will be assessed by 24h recalls
Measured: Change from baseline to 6 weeks
Change in energy intake
Energy intake (kcal/day) will be assessed by 24h recalls
Measured: Change from baseline to 6 weeks
Change in fat intake
Fat intake (g/day and percentage of energy intake) will be assessed by 24h recalls
Measured: Change from baseline to 6 weeks
Change in adherence to Mediterranean diet
Adherence to the Mediterranean dietary pattern will be assessed using validated questionnaires such as the PREDIMED questionnaire. The minimum value is 0 and the maximum value is 14. Higher values indicate better adherence to the Mediterranean diet and represent a better outcome.
Measured: Change from baseline to 6 weeks
Change in adherence to Mediterranean diet
Adherence to the Mediterranean dietary pattern will be assessed using validated questionnaires such as the PREDIMED questionnaire. The minimum value is 0 and the maximum value is 14. Higher values indicate better adherence to the Mediterranean diet and represent a better outcome.
Measured: Change from baseline to 12 weeks
Change in adherence to Mediterranean diet
Adherence to the Mediterranean dietary pattern will be assessed using validated questionnaires such as the PREDIMED questionnaire. The minimum value is 0 and the maximum value is 14. Higher values indicate better adherence to the Mediterranean diet and represent a better outcome.
Measured: Change from baseline to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 May 20235 Sep 2025

First posted9 Jun 2023
Study start2 May 2023
Primary completion27 Jul 2024
Study completion5 Sep 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Time Restricted FeedingStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 187 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05897073
Sponsor's protocol ID: TEMPUS
Acronym: TEMPUS
Status last verified: Sep 2025
First submitted: 5 May 2023
Last updated: 20 Nov 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Camacho-Cardenosa A, Clavero-Jimeno A, Martin-Olmedo JJ, Amaro-Gahete F, Cupeiro R, Cejudo MTG, Garcia Perez PV, Hernandez-Martinez C, Sevilla-Lorente R, De-la-O A, Lopez-Vazquez A, Molina-Fernandez M, Carneiro-Barrera A, Garcia F, Rodriguez-Nogales A, Galvez Peralta JJ, Cabeza R, Martin-Rodriguez JL, Munoz-Garach A, Munoz-Torres M, Labayen I, Ruiz JR. Time-restricted eating and supervised exercise for improving hepatic steatosis and cardiometabolic health in adults with obesity: protocol for the TEMPUS randomised controlled trial. BMJ Open. 2024 Jan 24;14(1):e078472. doi: 10.1136/bmjopen-2023-078472.
PubMed 38267239

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of Time-Restricted Eating and Supervised Exercise on Hepatic Steatosis and Cardiometabolic Health in Adults With Obesity
ClinicalTrials.gov ID: NCT05897073
Acronym / sponsor ID: TEMPUS / TEMPUS
Conditions: Time Restricted Feeding, Exercise, Hepatic Steatosis, Cardiometabolic Syndrome, Obesity
Study type: Interventional
Recruitment status: Completed
Enrolment: 187 participants (actual)
Lead sponsor: Universidad de GranadaUniversity, hospital or other
Study start: 2 May 2023 (actual)
Primary completion: 27 Jul 2024 (actual)
Study completion: 5 Sep 2025 (actual)
First posted: 9 Jun 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Time-restricted eating intervention	Experimental	Behavioral: Time-restricted eating interventionParticipants 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	Experimental	Behavioral: Exercise interventionThe 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.
Usual-care control group	No intervention	–Participants will receive standard recommendations on healthy lifestyle based on Mediterranean dietary pattern and physical activity recommendations for weight loss and health promotion.
Time-restricted eating plus Supervised exercise	Experimental	Behavioral: Time-restricted eating plus exercise interventionParticipants 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-

Who may qualify

Ages: 25 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (10 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Time-restricted eating interventionParticipants 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.	Behavioural	Time-restricted eating intervention
Exercise interventionThe 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.	Behavioural	Supervised exercise intervention
Time-restricted eating plus exercise interventionParticipants 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.	Behavioural	Time-restricted eating plus Supervised exercise

Primary outcome

Change in hepatic fat content
Time frame: Change from baseline to 12 weeks
Hepatic fat content will be assessed by Magnetic Resonance Imaging (MRI)

127 secondary outcomes

Change in liver stiffness
Time frame: Change from baseline to 12 weeks
Change in values of alkaline phosphatase
Time frame: Change from baseline to 12 weeks
Change in values of alanine transaminase
Time frame: Change from baseline to 12 weeks
Change in values of gamma-glutamyl transferase
Time frame: Change from baseline to 12 weeks
Change in visceral adipose tissue
Time frame: Change from baseline to 12 weeks
Change in abdominal subcutaneous adipose tissue
Time frame: Change from baseline to 12 weeks
Change in visceral adipose tissue
Time frame: Change from baseline to 12 months
Change in abdominal subcutaneous adipose tissue
Time frame: Change from baseline to 12 months
Change in pancreatic fat content
Time frame: Change from baseline to 12 weeks
Change in pancreatic fat content
Time frame: Change from baseline to 12 months
Change in values of fasting glucose
Time frame: Change from baseline to 12 weeks
Change in HOMA-IR index.
Time frame: Change from baseline to 12 weeks
Change in values of HbA1c
Time frame: Change from baseline to 12 weeks
Change in values of fasting triglycerides
Time frame: Change from baseline to 12 weeks
Change in values of fasting high-density lipoprotein cholesterol
Time frame: Change from baseline to 12 weeks
Change in values of fasting low-density lipoprotein cholesterol
Time frame: Change from baseline to 12 weeks
Change in values of fasting total cholesterol
Time frame: Change from baseline to 12 weeks
Change in values of C-reactive protein
Time frame: Change from baseline to 12 weeks
Change in values of interleukin 6
Time frame: Change from baseline to 12 weeks
Change in values of apolipoprotein A1
Time frame: Change from baseline to 12 weeks
Change in values of apolipoprotein B
Time frame: Change from baseline to 12 weeks
Change in levels of mean glucose (Continuous Glucose Monitoring)
Time frame: Change from baseline to the last 2 weeks of intervention
Change in 2-hour plasma glucose
Time frame: Change in 2-hour plasma glucose baseline and 12 weeks
Change in Body weight
Time frame: Change from baseline to 12 weeks
Change in Body weight
Time frame: Change from baseline to 12 months
Change in Body height
Time frame: Change from baseline to 12 weeks
Change in Body height
Time frame: Change from baseline to 12 months
Change in waist circumference
Time frame: Change from baseline to 12 weeks
Change in calf girth
Time frame: Change from baseline to 12 weeks
Change in waist circumference
Time frame: Change from baseline to 12 months
Change in calf girth
Time frame: Change from baseline to 12 months
Change in hip circumference
Time frame: Change from baseline to 12 weeks
Change in hip circumference
Time frame: Change from baseline to 12 months
Change in neck circumference
Time frame: Change from baseline to 12 weeks
Change in neck circumference
Time frame: Change from baseline to 12 months
Change in systolic blood pressure
Time frame: Change from baseline to 12 weeks
Change in systolic blood pressure
Time frame: Change from baseline to 12 months
Change in diastolic blood pressure
Time frame: Change from baseline to 12 weeks
Change in diastolic blood pressure
Time frame: Change from baseline to 12 months
Change in energy intake
Time frame: Change from baseline to 12 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
Derived from this study: PubMed 38267239Camacho-Cardenosa A, Clavero-Jimeno A, Martin-Olmedo JJ, Amaro-Gahete F, Cupeiro R, Cejudo MTG, Garcia Perez PV, Hernandez-Martinez C, Sevilla-Lorente R, De-la-O A, Lopez-Vazquez A, Molina-Fernandez M, Carneiro-Barrera A, Garcia F, Rodriguez-Nogales A, Galvez Peralta JJ, Cabeza R, Martin-Rodriguez JL, Munoz-Garach A, Munoz-Torres M, Labayen I, Ruiz JR. Time-restricted eating and supervised exercise for improving hepatic steatosis and cardiometabolic health in adults with obesity: protocol for the TEMPUS randomised controlled trial. BMJ Open. 2024 Jan 24;14(1):e078472. doi: 10.1136/bmjopen-2023-078472.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jonatan R. Ruiz, PhD principal investigator

Universidad de Granada

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in hepatic fat content (time frame: Change from baseline to 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05897073, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.