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

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: Completed
• Conditions: Obesity; Exercise; Hepatic Steatosis; Time Restricted Feeding; Cardiometabolic Syndrome
• Intervention / Treatment: Behavioral: Time-restricted eating intervention; Behavioral: Exercise intervention; Behavioral: Time-restricted eating plus exercise intervention

• Study Type: Interventional
• Enrollment (Actual): 187
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Change in hepatic fat content	Hepatic fat content will be assessed by Magnetic Resonance Imaging (MRI)	Change from baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in visceral adipose tissue	Visceral adipose tissue will be assessed by Magnetic Resonance Imaging (MRI)	Change from baseline to 12 weeks
Change in Body weight	Body weight will be measured by a digital scale	Change from baseline to 12 weeks
Change in energy intake	Energy intake (kcal/day) will be assessed by 24h recalls	Change from baseline to 12 weeks
Change in Objectively sleep quality	Objectively sleep quality will be assessed by accelerometry	Change from baseline to 12 weeks
Change in values of alkaline phosphatase	Fasting blood samples will be used to asses alkaline phosphatase	Change from baseline to 12 weeks
Change in values of gamma-glutamyl transferase	Fasting blood samples will be used to assess gamma-glutamyl transferase	Change from baseline to 12 weeks
Change in pancreatic fat content	Pancreatic fat content will be assessed by Magnetic Resonance Imaging (MRI)	Change from baseline to 12 weeks
Change in values of fasting glucose	Fasting blood samples will be used to assess glucose	Change from baseline to 12 weeks
Change in values of fasting insulin	Fasting blood samples will be used to assess insulin	Change from baseline to 12 weeks
Change in values of fasting triglycerides	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	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	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	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	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	Fasting blood samples will be used to assess levels of interleukin 6	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	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	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	Change from baseline to 12 weeks
Change in systolic blood pressure	Systolic blood pressure will be assessed by blood pressure monitor	Change from baseline to 12 weeks
Change in diastolic blood pressure	Diastolic blood pressure will be assessed by blood pressure monitor	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	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	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	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.	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.	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.	Change from baseline to 12 weeks
Change in Chronotype	Chronotype will be assessed by the Munich Chronotype Questionnaire (MCTQ).	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.	Change from baseline to 12 weeks
Change Objectively moderate to vigorous physical activity levels	Objectively physical activity levels will be assessed by accelerometry	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.	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.	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.	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.	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.	Change from baseline to 12 weeks
Change in values of alanine transaminase	Fasting blood samples will be used to asses alanine transaminase	Change from baseline to 12 weeks
Change in Body height	Body height will be measured by a stadiometer	Change from baseline to 12 weeks
Change in Cardiorespiratory Fitness	Cardiorespiratory fitness measured by maximum treadmill test	Change from baseline to 12 weeks
Change in Lower muscular strength	Lower body muscular strength measured by chair stand test.	Change from baseline to 12 weeks
Change in Upper muscular strength	Upper body muscular strength measured by hand grip strength test.	Change from baseline to 12 weeks
Change in walking speed.	Walking speed measured by gait speed test. Higher values mean worse performance.	Change from baseline to 12 weeks
Change in abdominal subcutaneous adipose tissue	Abdominal subcutaneous adipose tissue will be assessed by Magnetic Resonance Imaging (MRI)	Change from baseline to 12 weeks
Change in values of HbA1c	Fasting blood samples will be used to assess HbA1c	Change from baseline to 12 weeks
Change in values of apolipoprotein A1	Fasting blood samples will be used to assess levels of apolipoprotein A1	Change from baseline to 12 weeks
Change in values of apolipoprotein B	Fasting blood samples will be used to assess levels of apolipoprotein B	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	Change from baseline to 12 weeks
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.	Change from baseline to 12 weeks
Change in visceral adipose tissue	Visceral adipose tissue will be assessed by Magnetic Resonance Imaging (MRI)	Change from baseline to 12 months
Change in abdominal subcutaneous adipose tissue	Abdominal subcutaneous adipose tissue will be assessed by Magnetic Resonance Imaging (MRI)	Change from baseline to 12 months
Change in pancreatic fat content	Pancreatic fat content will be assessed by Magnetic Resonance Imaging (MRI)	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	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	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.	Change in 2-hour plasma glucose baseline and 12 weeks
Change in Body weight	Body weight will be measured by a digital scale	Change from baseline to 12 months
Change in Body height	Body height will be measured by a stadiometer	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	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	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	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	Change from baseline to 12 months
Change in systolic blood pressure	Systolic blood pressure will be assessed by blood pressure monitor	Change from baseline to 12 months
Change in diastolic blood pressure	Diastolic blood pressure will be assessed by blood pressure monitor	Change from baseline to 12 months
Change in fecal microbiota composition	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	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	Adherence will be assessed by eating records through the mobile phone app.	During the 12 weeks
Attendance to the exercise intervention	Attendance will be assessed by number of completed exercise sessions.	During the 12 weeks
Change in hepatic fat content	Hepatic fat content will be assessed by Magnetic Resonance Imaging (MRI)	Change from baseline to 12 months
Change in abdominal intermuscular fat content	Abdominal intermuscular fat content will be assessed by Magnetic Resonance Imaging (MRI)	Change from baseline to 12 weeks
Change in abdominal intermuscular fat content	Abdominal intermuscular fat content will be assessed by Magnetic Resonance Imaging (MRI)	Change from baseline to 12 months
Change in abdominal skeletal muscle tissue	Abdominal skeletal muscle tissue will be assessed by Magnetic Resonance Imaging (MRI)	Change from baseline to 12 months
Change in abdominal skeletal muscle tissue	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	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	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	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	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	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	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	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	Mid-thigh skeletal muscle tissue will be assessed by Magnetic Resonance Imaging (MRI)	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.	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.	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.	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.	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.	Change from baseline to 12 months
Change in Fat Mass	Fat mass will be assessed by assessed by bioelectrical impedance analysis (BIA).	Change from baseline to 12 weeks
Change in Fat Mass	Fat mass will be assessed by assessed by bioelectrical impedance analysis (BIA).	Change from baseline to 12 months
Change in Fat-free Mass	Fat-free mass will be assessed by assessed by bioelectrical impedance analysis (BIA).	Change from baseline to 12 weeks
Change in Fat-free Mass	Fat-free mass will be assessed by assessed by bioelectrical impedance analysis (BIA).	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).	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).	Change from baseline to 12 weeks
Change in values of alkaline phosphatase	Fasting blood samples will be used to asses alkaline phosphatase	Change from baseline to 12 months
Change in values of alanine transaminase	Fasting blood samples will be used to asses alanine transaminase	Change from baseline to 12 months
Change in values of aspartate aminotransferase	Fasting blood samples will be used to asses aspartate aminotransferase	Change from baseline to 12 weeks
Change in values of aspartate aminotransferase	Fasting blood samples will be used to asses aspartate aminotransferase	Change from baseline to 12 months
Change in values of gamma-glutamyl transferase	Fasting blood samples will be used to assess gamma-glutamyl transferase	Change from baseline to 12 months
Change in values of HbA1c	Fasting blood samples will be used to assess HbA1c	Change from baseline to 12 months
Change in values of fasting glucose	Fasting blood samples will be used to assess glucose	Change from baseline to 12 months
Change in values of fasting insulin	Fasting blood samples will be used to assess insulin	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	Change from baseline to 12 months
Change in values of fasting triglycerides	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	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	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	Fasting blood samples will be used to assess levels of total cholesterol	Change from baseline to 12 months
Change in values of apolipoprotein A1	Fasting blood samples will be used to assess levels of apolipoprotein A1	Change from baseline to 12 months
Change in values of apolipoprotein B	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	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	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	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	Fasting urine samples will be used to assess levels of essential amino acids.	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	Change from baseline to 12 weeks
Change in rest-activity rhythms	Rest-activity rhythms will be assessed by accelerometry	Change from baseline to the last 2 weeks of intervention
Change in steps counts	Steps counts will be assessed by activity band	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).	Change from baseline to 6 weeks
Change in Fat-free Mass	Fat-free mass will be assessed by assessed by bioelectrical impedance analysis (BIA).	Change from baseline to 6 weeks
Change in Body weight	Body weight will be measured by a digital scale	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	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	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	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	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).	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.	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	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	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	Change from baseline to 6 weeks
Change in energy intake	Energy intake (kcal/day) will be assessed by 24h recalls	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	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.	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.	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.	Change from baseline to 12 months

Collaborators and Investigators

• Sponsor: Universidad de Granada
• Investigators: Principal Investigator: Jonatan R. Ruiz, PhD, Universidad de Granada

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2023
• Primary Completion (Actual): July 27, 2024
• Study Completion (Actual): September 5, 2025

Study Registration Dates

• First Submitted: May 5, 2023
• First Submitted That Met QC Criteria: May 31, 2023
• First Posted (Actual): June 9, 2023

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Digestive System Diseases; Glucose Metabolism Disorders; Liver Diseases; Insulin Resistance; Hyperinsulinism; Overweight; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Feeding Behavior; Fasting; Obesity; Metabolic Syndrome; Fatty Liver; Motor Activity; Intermittent Fasting
• Other Study ID 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