Time-Restricted Eating, Exercise and Cardiometabolic Health in Obesity

Obesity Clinical Trial

— TEMPUS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05897073
• Other study ID #: TEMPUS
• Status: Recruiting
• Phase: N/A
• Start date: May 2, 2023
• Est. completion date: December 2025

Study information

• Verified date: December 2023
• Source: Universidad de Granada
• Contact: Jonatan R. Ruiz, PhD
• Phone: 0034958242754
• Email: ruizj[@]ugr.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In Spain, overweight and obesity prevalence is reaching 70% in men and 50% in women. Excess of triglycerides are usually stored in the subcutaneous adipose tissue (SAT), until a point where SAT is unable to expand further. Therefore, lipids are deposited in visceral and other peripheral organs and tissues that are not otherwise designed for adipose storage such as the liver, pancreas or the skeletal muscle, a process known as ectopic fat deposition. "Time-restricted eating" (TRE) is a recently emerged intermittent fasting approach which has the potential to maximize the beneficial metabolic effects extensively reported for energy intake restriction. Furthermore, exercise reduces hepatic steatosis and improves cardiometabolic health in humans. However, whether the effects of TRE combined with exercise on reducing hepatic steatosis are superior to TRE or exercise intervention alone remains unknown. The TEMPUS study will investigate the effects of a 12-week TRE combined with supervised exercise intervention, as compared with TRE or exercise alone, and usual-care control group, on hepatic fat (primary outcome) and cardiometabolic health (secondary outcomes) in adults with obesity; and to unveil the role of gut microbiota.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 184
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiometabolic Syndrome
• Exercise
• Fatty Liver
• Hepatic Steatosis
• Metabolic Syndrome
• Obesity
• Time Restricted Feeding

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Spain	University of Granada	Granada
Spain	University of Granada - Instituto Mixto Universitario Deporte y Salud	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in hepatic fat content	Hepatic fat content will be assessed by Magnetic Resonance Imaging (MRI)	Change from baseline to 12 weeks
Secondary	Change in hepatic elasticity	Viscosity, fibrosis severity and steatosis will be assessed by US elastography	Change from baseline to 12 weeks
Secondary	Change in values of alkaline phosphatase	Fasting blood samples will be used to asses alkaline phosphatase	Change from baseline to 12 weeks
Secondary	Change in values of alanine transaminase	Fasting blood samples will be used to asses alanine transaminase	Change from baseline to 12 weeks
Secondary	Change in values of gamma-glutamyl transferase	Fasting blood samples will be used to assess gamma-glutamyl transferase	Change from baseline to 12 weeks
Secondary	Change in values of Vitamin D	Fasting blood samples will be used to assess Vitamin D	Change from baseline to 12 weeks
Secondary	Change in values of Calcium	Fasting blood samples will be used to assess Calcium	Change from baseline to 12 weeks
Secondary	Change in values of Bilrubin	Fasting blood samples will be used to assess Bilrubin	Change from baseline to 12 weeks
Secondary	Change in values of glomerular filtration rate	Fasting blood samples will be used to assess glomerular filtration rate	Change from baseline to 12 weeks
Secondary	Change in values of estradiol	Fasting blood samples will be used to assess estradiol	Change from baseline to 12 weeks
Secondary	Change in values of progesterone	Fasting blood samples will be used to assess progesterone	Change from baseline to 12 weeks
Secondary	Change in values of testosterone	Fasting blood samples will be used to assess testosterone	Change from baseline to 12 weeks
Secondary	Change in values of follicle stimulating hormone	Fasting blood samples will be used to assess follicle stimulating hormone	Change from baseline to 12 weeks
Secondary	Change in values of luteinizing hormone	Fasting blood samples will be used to assess luteinizing hormone	Change from baseline to 12 weeks
Secondary	Change in values of thyrotropin	Fasting blood samples will be used to assess thyrotropin	Change from baseline to 12 weeks
Secondary	Change in values of thyroxine	Fasting blood samples will be used to assess thyroxine	Change from baseline to 12 weeks
Secondary	Change in values of triiodothyronine	Fasting blood samples will be used to assess triiodothyronine	Change from baseline to 12 weeks
Secondary	Change in visceral adipose tissue	Visceral adipose tissue will be assessed by Magnetic Resonance Imaging (MRI)	Change from baseline to 12 weeks
Secondary	Change in abdominal subcutaneous adipose tissue	Abdominal subcutaneous adipose tissue will be assessed by Magnetic Resonance Imaging (MRI)	Change from baseline to 12 weeks
Secondary	Change in visceral adipose tissue	Visceral adipose tissue will be assessed by Magnetic Resonance Imaging (MRI)	Change from 12 weeks of intervention to 12 months
Secondary	Change in abdominal subcutaneous adipose tissue	Abdominal subcutaneous adipose tissue will be assessed by Magnetic Resonance Imaging (MRI)	Change from 12 weeks of intervention to 12 months
Secondary	Change in pancreatic fat content	Pancreatic fat content will be assessed by Magnetic Resonance Imaging (MRI)	Change from baseline to 12 weeks
Secondary	Change in pancreatic fat content	Pancreatic fat content will be assessed by Magnetic Resonance Imaging (MRI)	Change from 12 weeks of intervention to 12 months
Secondary	Change in intramuscular fat content	Intramuscular fat content will be assessed by Magnetic Resonance Imaging (MRI)	Change from baseline to 12 weeks
Secondary	Change in intramuscular fat content	Intramuscular fat content will be assessed by Magnetic Resonance Imaging (MRI)	Change from 12 weeks of intervention to 12 months
Secondary	Change in values of fasting glucose	Fasting blood samples will be used to assess glucose	Change from baseline to 12 weeks
Secondary	Change in HOMA-IR index.	Fasting blood samples will be used to assess glucose and insuline and HOMA index will be computed	Change from baseline to 12 weeks
Secondary	Change in values of HbA1c	Fasting blood samples will be used to assess HbA1c	Change from baseline to 12 weeks
Secondary	Change in values of fasting triglycerides	Fasting blood samples will be used to assess levels of triglycerides	Change from baseline to 12 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in values of interleukin 6	Fasting blood samples will be used to assess levels of interleukin 6	Change from baseline to 12 weeks
Secondary	Change in values of creatinine	Fasting blood samples will be used to assess levels of creatinine	Change from baseline to 12 weeks
Secondary	Change in values of creatine kinase	Fasting blood samples will be used to assess levels of creatine kinase	Change from baseline to 12 weeks
Secondary	Change in values of iron	Fasting blood samples will be used to assess levels of iron	Change from baseline to 12 weeks
Secondary	Change in values of ferritin	Fasting blood samples will be used to assess levels of ferritin	Change from baseline to 12 weeks
Secondary	Change in values of folic acid	Fasting blood samples will be used to assess levels of folic acid	Change from baseline to 12 weeks
Secondary	Change in values of apolipoprotein A1	Fasting blood samples will be used to assess levels of apolipoprotein A1	Change from baseline to 12 weeks
Secondary	Change in values of apolipoprotein B	Fasting blood samples will be used to assess levels of apolipoprotein B	Change from baseline to 12 weeks
Secondary	Change in levels of mean glucose (Continuous Glucose Monitoring)	Men glucose over 14 days will be assessed by Continuous Glucose Monitoring during 2 weeks	Change from baseline to the last 2 weeks of intervention
Secondary	Change in quantitative insulin-sensitivity check index	Quantitative insulin-sensitivity check index will be assessed by oral glucose tolerance test	Change from baseline to the last 2 weeks of intervention
Secondary	Change in Body weight	Body weight will be measured by a digital scale	Change from baseline to 12 weeks
Secondary	Change in Body weight	Body weight will be measured by a digital scale	Change from 12 weeks of intervention to 12 months
Secondary	Change in Body height	Body height will be measured by a stadiometer	Change from baseline to 12 weeks
Secondary	Change in Body height	Body height will be measured by a stadiometer	Change from 12 weeks of intervention to 12 months
Secondary	Change in fat mass	Fat mass will be assessed by Dual-energy X-ray Absorptiometry (DXA)	Change from baseline to 12 weeks
Secondary	Change in fat free mass	Fat free mass will be assessed by Dual-energy X-ray Absorptiometry (DXA)	Change from baseline to 12 weeks
Secondary	Change in bone mineral density	Bone mineral density will be assessed by Dual-energy X-ray Absorptiometry (DXA)	Change from baseline to 12 weeks
Secondary	Change in fat mass	Fat mass will be assessed by Dual-energy X-ray Absorptiometry (DXA)	Change from 12 weeks of intervention to 12 months
Secondary	Change in fat free mass	Fat free mass will be assessed by Dual-energy X-ray Absorptiometry (DXA)	Change from 12 weeks of intervention to 12 months
Secondary	Change in bone mineral density	Bone mineral density will be assessed by Dual-energy X-ray Absorptiometry (DXA)	Change from 12 weeks of intervention to 12 months
Secondary	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
Secondary	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
Secondary	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 12 weeks of intervention to 12 months
Secondary	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 12 weeks of intervention to 12 months
Secondary	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
Secondary	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 12 weeks of intervention to 12 months
Secondary	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
Secondary	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 12 weeks of intervention to 12 months
Secondary	Change in systolic blood pressure	Systolic blood pressure will be assessed by blood pressure monitor	Change from baseline to 12 weeks
Secondary	Change in systolic blood pressure	Systolic blood pressure will be assessed by blood pressure monitor	Change from 12 weeks of intervention to 12 months
Secondary	Change in diastolic blood pressure	Diastolic blood pressure will be assessed by blood pressure monitor	Change from baseline to 12 weeks
Secondary	Change in diastolic blood pressure	Diastolic blood pressure will be assessed by blood pressure monitor	Change from 12 weeks of intervention to 12 months
Secondary	Change in energy intake	Energy intake (kcal/day) will be assessed by 24h recalls	Change from baseline to 12 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in Objectively sleep quality	Objectively sleep quality will be assessed by accelerometry	Change from baseline to 12 weeks
Secondary	Change in Chronotype	Chronotype will be assessed by the Munich Chronotype Questionnaire (MCTQ).	Change from baseline to 12 weeks
Secondary	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
Secondary	Change Objectively moderate to vigorous physical activity levels	Objectively physical activity levels will be assessed by accelerometry	Change from baseline to 12 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in Gut microbiota composition	DNA sequencing to determine gut microbiota composition (e.g., phylum and genera)	Change from baseline to 12 weeks
Secondary	Change in fecal microbiota diversity	DNA sequencing to determine gut microbiota diversity (e.g., beta and alpha)	Change from baseline to 12 weeks
Secondary	Change in Cardiorespiratory Fitness	Cardiorespiratory fitness measured by maximum treadmill test	Change from baseline to 12 weeks
Secondary	Change in Lower muscular strength	Lower body muscular strength measured by chair stand test.	Change from baseline to 12 weeks
Secondary	Change in Upper muscular strength	Upper body muscular strength measured by hand grip strength test.	Change from baseline to 12 weeks
Secondary	Change in walking speed.	Walking speed measured by gait speed test. Higher values mean worse performance.	Change from baseline to 12 weeks
Secondary	Adherence to the time-restricted eating intervention	Adherence will be assessed by eating records through the mobile phone app.	Change from baseline to 12 weeks
Secondary	Adherence to the exercise intervention	Adherence will be assessed by number of completed exercise sessions.	Change from baseline to 12 weeks
Secondary	Change in hepatic fat content	Hepatic fat content will be assessed by Magnetic Resonance Imaging (MRI)	Change from 12 weeks of intervention to 12 months