Time-Restricted Eating, Exercise and Cardiometabolic Health in Obesity (TEMPUS)

November 19, 2025 updated by: Jonatan Ruiz Ruiz, Universidad de Granada

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
187

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Jonatan R. Ruiz, PhD
  • Phone Number: 0034958242754
  • Email: ruizj@ugr.es

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Time-restricted eating intervention
Participants will be asked to reduce their daily eating time window to a maximum of 8 hours/day. They can choose when to begin their eating window but will be advised that the last meal should be completed before or at 20:00 hours. No calorie-containing food or beverage intake will be allowed outside the 8 hours eating window.
Behavioral: Time-restricted eating intervention
Participants will be asked to reduce their daily eating time window to a maximum of 8 hours/day. They can choose when to begin their eating window but will be advised that the last meal should be completed before or at 20:00 hours. No calorie-containing food or beverage intake will be allowed outside the 8 hours eating window.
Experimental: Supervised exercise intervention
The exercise intervention will include 2 days/week of supervised moderate-high intensity resistance training (rating perceived exertion >7, circuit-training, upper and lower body exercises involving major muscle groups) and high-intensity interval training (4 sets of 4-minute intervals at >85% peak heat rate with 4-minute of active recovery at 50-65% peak heat rate, uphill treadmill walking). Moreover, participants will receive an individualized moderate-intensity goal-setting aerobic (walking) program consisting of increasing 15% daily steps per week.
Behavioral: Exercise intervention
The exercise intervention will include 2 days/week of supervised moderate-high intensity resistance training (rating perceived exertion >7, circuit-training, upper and lower body exercises involving major muscle groups) and high-intensity interval training (4 sets of 4-minute intervals at >85% peak heat rate with 4-minute of active recovery at 50-65% peak heat rate, uphill treadmill walking). 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.
No Intervention: Usual-care control group
Participants will receive standard recommendations on healthy lifestyle based on Mediterranean dietary pattern and physical activity recommendations for weight loss and health promotion.
Experimental: Time-restricted eating plus Supervised exercise
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-
Behavioral: Time-restricted eating plus exercise intervention
Participants will be asked to reduce their daily eating time window to a maximum of 8 hours/day. They can choose when to begin their eating window but will be advised that the last meal should be completed before or at 20:00 hours. No calorie-containing food or beverage intake will be allowed outside the 8 hours eating window. The exercise intervention will include 2 days/week of supervised moderate-high intensity resistance training (rating perceived exertion >7, circuit-training, upper and lower body exercises involving major muscle groups) and high-intensity interval training (4 sets of 4-minute intervals at >85% peak heat rate with 4-minute of active recovery at 50-65% peak heat rate, uphill treadmill walking). 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in hepatic fat content
Time Frame: Change from baseline to 12 weeks
Hepatic fat content will be assessed by Magnetic Resonance Imaging (MRI)
Change from baseline to 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in visceral adipose tissue
Time Frame: Change from baseline to 12 weeks
Visceral adipose tissue will be assessed by Magnetic Resonance Imaging (MRI)
Change from baseline to 12 weeks
Change in Body weight
Time Frame: Change from baseline to 12 weeks
Body weight will be measured by a digital scale
Change from baseline to 12 weeks
Change in energy intake
Time Frame: Change from baseline to 12 weeks
Energy intake (kcal/day) will be assessed by 24h recalls
Change from baseline to 12 weeks
Change in Objectively sleep quality
Time Frame: Change from baseline to 12 weeks
Objectively sleep quality will be assessed by accelerometry
Change from baseline to 12 weeks
Change in values of alkaline phosphatase
Time Frame: Change from baseline to 12 weeks
Fasting blood samples will be used to asses alkaline phosphatase
Change from baseline to 12 weeks
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
Change from baseline to 12 weeks
Change in pancreatic fat content
Time Frame: Change from baseline to 12 weeks
Pancreatic fat content will be assessed by Magnetic Resonance Imaging (MRI)
Change from baseline to 12 weeks
Change in values of fasting glucose
Time Frame: Change from baseline to 12 weeks
Fasting blood samples will be used to assess glucose
Change from baseline to 12 weeks
Change in values of fasting insulin
Time Frame: Change from baseline to 12 weeks
Fasting blood samples will be used to assess insulin
Change from baseline to 12 weeks
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
Change from baseline to 12 weeks
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
Change from baseline to 12 weeks
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
Change from baseline to 12 weeks
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
Change from baseline to 12 weeks
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
Change from baseline to 12 weeks
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
Change from baseline to 12 weeks
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
Change from baseline to 12 weeks
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
Change from baseline to 12 weeks
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
Change from baseline to 12 weeks
Change in systolic blood pressure
Time Frame: Change from baseline to 12 weeks
Systolic blood pressure will be assessed by blood pressure monitor
Change from baseline to 12 weeks
Change in diastolic blood pressure
Time Frame: Change from baseline to 12 weeks
Diastolic blood pressure will be assessed by blood pressure monitor
Change from baseline to 12 weeks
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
Change from baseline to 12 weeks
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
Change from baseline to 12 weeks
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
Change from baseline to 12 weeks
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.
Change from baseline to 12 weeks
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.
Change from baseline to 12 weeks
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.
Change from baseline to 12 weeks
Change in Chronotype
Time Frame: Change from baseline to 12 weeks
Chronotype will be assessed by the Munich Chronotype Questionnaire (MCTQ).
Change from baseline to 12 weeks
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.
Change from baseline to 12 weeks
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
Change from baseline to 12 weeks
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.
Change from baseline to 12 weeks
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.
Change from baseline to 12 weeks
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.
Change from baseline to 12 weeks
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.
Change from baseline to 12 weeks
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.
Change from baseline to 12 weeks
Change in values of alanine transaminase
Time Frame: Change from baseline to 12 weeks
Fasting blood samples will be used to asses alanine transaminase
Change from baseline to 12 weeks
Change in Body height
Time Frame: Change from baseline to 12 weeks
Body height will be measured by a stadiometer
Change from baseline to 12 weeks
Change in Cardiorespiratory Fitness
Time Frame: Change from baseline to 12 weeks
Cardiorespiratory fitness measured by maximum treadmill test
Change from baseline to 12 weeks
Change in Lower muscular strength
Time Frame: Change from baseline to 12 weeks
Lower body muscular strength measured by chair stand test.
Change from baseline to 12 weeks
Change in Upper muscular strength
Time Frame: Change from baseline to 12 weeks
Upper body muscular strength measured by hand grip strength test.
Change from baseline to 12 weeks
Change in walking speed.
Time Frame: Change from baseline to 12 weeks
Walking speed measured by gait speed test. Higher values mean worse performance.
Change from baseline to 12 weeks
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)
Change from baseline to 12 weeks
Change in values of HbA1c
Time Frame: Change from baseline to 12 weeks
Fasting blood samples will be used to assess HbA1c
Change from baseline to 12 weeks
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
Change from baseline to 12 weeks
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
Change from baseline to 12 weeks
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
Change from baseline to 12 weeks
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.
Change from baseline to 12 weeks
Change in visceral adipose tissue
Time Frame: Change from baseline to 12 months
Visceral adipose tissue will be assessed by Magnetic Resonance Imaging (MRI)
Change from baseline to 12 months
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)
Change from baseline to 12 months
Change in pancreatic fat content
Time Frame: Change from baseline to 12 months
Pancreatic fat content will be assessed by Magnetic Resonance Imaging (MRI)
Change from baseline to 12 months
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
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
24-hour, diurnal and nocturnal mean glucose over 14 days will be assessed by Continuous Glucose Monitoring during 2 weeks
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
2-hour plasma glucose will be assessed by oral glucose tolerance test.
Change in 2-hour plasma glucose baseline and 12 weeks
Change in Body weight
Time Frame: Change from baseline to 12 months
Body weight will be measured by a digital scale
Change from baseline to 12 months
Change in Body height
Time Frame: Change from baseline to 12 months
Body height will be measured by a stadiometer
Change from baseline to 12 months
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
Change from baseline to 12 months
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
Change from baseline to 12 months
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
Change from baseline to 12 months
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
Change from baseline to 12 months
Change in systolic blood pressure
Time Frame: Change from baseline to 12 months
Systolic blood pressure will be assessed by blood pressure monitor
Change from baseline to 12 months
Change in diastolic blood pressure
Time Frame: Change from baseline to 12 months
Diastolic blood pressure will be assessed by blood pressure monitor
Change from baseline to 12 months
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).
Change from baseline to 12 weeks
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).
Change from baseline to 12 weeks
Adherence to the eating window
Time Frame: During the 12 weeks
Adherence will be assessed by eating records through the mobile phone app.
During the 12 weeks
Attendance to the exercise intervention
Time Frame: During the 12 weeks
Attendance will be assessed by number of completed exercise sessions.
During the 12 weeks
Change in hepatic fat content
Time Frame: Change from baseline to 12 months
Hepatic fat content will be assessed by Magnetic Resonance Imaging (MRI)
Change from baseline to 12 months
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)
Change from baseline to 12 weeks
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)
Change from baseline to 12 months
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)
Change from baseline to 12 months
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)
Change from baseline to 12 weeks
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)
Change from baseline to 12 weeks
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)
Change from baseline to 12 months
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)
Change from baseline to 12 weeks
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)
Change from baseline to 12 months
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)
Change from baseline to 12 weeks
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)
Change from baseline to 12 months
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)
Change from baseline to 12 weeks
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)
Change from baseline to 12 months
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.
Change from baseline to 12 months
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.
Change from baseline to 12 weeks
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.
Change from baseline to 12 months
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.
Change from baseline to 12 weeks
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.
Change from baseline to 12 months
Change in Fat Mass
Time Frame: Change from baseline to 12 weeks
Fat mass will be assessed by assessed by bioelectrical impedance analysis (BIA).
Change from baseline to 12 weeks
Change in Fat Mass
Time Frame: Change from baseline to 12 months
Fat mass will be assessed by assessed by bioelectrical impedance analysis (BIA).
Change from baseline to 12 months
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).
Change from baseline to 12 weeks
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).
Change from baseline to 12 months
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).
Change from baseline to 12 months
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).
Change from baseline to 12 weeks
Change in values of alkaline phosphatase
Time Frame: Change from baseline to 12 months
Fasting blood samples will be used to asses alkaline phosphatase
Change from baseline to 12 months
Change in values of alanine transaminase
Time Frame: Change from baseline to 12 months
Fasting blood samples will be used to asses alanine transaminase
Change from baseline to 12 months
Change in values of aspartate aminotransferase
Time Frame: Change from baseline to 12 weeks
Fasting blood samples will be used to asses aspartate aminotransferase
Change from baseline to 12 weeks
Change in values of aspartate aminotransferase
Time Frame: Change from baseline to 12 months
Fasting blood samples will be used to asses aspartate aminotransferase
Change from baseline to 12 months
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
Change from baseline to 12 months
Change in values of HbA1c
Time Frame: Change from baseline to 12 months
Fasting blood samples will be used to assess HbA1c
Change from baseline to 12 months
Change in values of fasting glucose
Time Frame: Change from baseline to 12 months
Fasting blood samples will be used to assess glucose
Change from baseline to 12 months
Change in values of fasting insulin
Time Frame: Change from baseline to 12 months
Fasting blood samples will be used to assess insulin
Change from baseline to 12 months
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
Change from baseline to 12 months
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
Change from baseline to 12 months
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
Change from baseline to 12 months
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
Change from baseline to 12 months
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
Change from baseline to 12 months
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
Change from baseline to 12 months
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
Change from baseline to 12 months
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
Change from baseline to 12 months
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
Change from baseline to 12 months
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.
Change from baseline to 12 weeks
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.
Change from baseline to 12 weeks
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
Change from baseline to 12 weeks
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
Change from baseline to the last 2 weeks of intervention
Change in steps counts
Time Frame: Change from baseline to the last 2 weeks of intervention
Steps counts will be assessed by activity band
Change from baseline to the last 2 weeks of intervention
Change in Fat Mass
Time Frame: Change from baseline to 6 weeks
Fat mass will be assessed by assessed by bioelectrical impedance analysis (BIA).
Change from baseline to 6 weeks
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).
Change from baseline to 6 weeks
Change in Body weight
Time Frame: Change from baseline to 6 weeks
Body weight will be measured by a digital scale
Change from baseline to 6 weeks
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
Change from baseline to 6 weeks
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
Change from baseline to 6 weeks
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
Change from baseline to 6 weeks
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
Change from baseline to 6 weeks
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).
Change from baseline to 6 weeks
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.
Change from baseline to 12 weeks
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
Change from baseline to 6 weeks
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
Change from baseline to 6 weeks
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
Change from baseline to 6 weeks
Change in energy intake
Time Frame: Change from baseline to 6 weeks
Energy intake (kcal/day) will be assessed by 24h recalls
Change from baseline to 6 weeks
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
Change from baseline to 6 weeks
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.
Change from baseline to 6 weeks
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.
Change from baseline to 12 weeks
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.
Change from baseline to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad de Granada

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jonatan R. Ruiz, PhD, Universidad de Granada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 2, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 27, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 5, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 5, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 20, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TEMPUS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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