Clinical trial NCT05897073: Time-Restricted Eating, Exercise and Cardiometabolic Health in Obesity
Official title: Impact of Time-Restricted Eating and Supervised Exercise on Hepatic Steatosis and Cardiometabolic Health in Adults With Obesity
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Time Restricted Feeding
Exercise
Hepatic Steatosis
Cardiometabolic Syndrome
Obesity
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2023-06-09
Enrollment: 184
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Change in hepatic fat content
timeFrame: Change from baseline to 12 weeks
Secondary outcomes:
measure: Change in hepatic elasticity
timeFrame: Change from baseline to 12 weeks
measure: Change in values of alkaline phosphatase
timeFrame: Change from baseline to 12 weeks
measure: Change in values of alanine transaminase
timeFrame: Change from baseline to 12 weeks
measure: Change in values of gamma-glutamyl transferase
timeFrame: Change from baseline to 12 weeks
measure: Change in values of Vitamin D
timeFrame: Change from baseline to 12 weeks
measure: Change in values of Calcium
timeFrame: Change from baseline to 12 weeks
measure: Change in values of Bilrubin
timeFrame: Change from baseline to 12 weeks
measure: Change in values of glomerular filtration rate
timeFrame: Change from baseline to 12 weeks
measure: Change in values of estradiol
timeFrame: Change from baseline to 12 weeks
measure: Change in values of progesterone
timeFrame: Change from baseline to 12 weeks
measure: Change in values of testosterone
timeFrame: Change from baseline to 12 weeks
measure: Change in values of follicle stimulating hormone
timeFrame: Change from baseline to 12 weeks
measure: Change in values of luteinizing hormone
timeFrame: Change from baseline to 12 weeks
measure: Change in values of thyrotropin
timeFrame: Change from baseline to 12 weeks
measure: Change in values of thyroxine
timeFrame: Change from baseline to 12 weeks
measure: Change in values of triiodothyronine
timeFrame: Change from baseline to 12 weeks
measure: Change in visceral adipose tissue
timeFrame: Change from baseline to 12 weeks
measure: Change in abdominal subcutaneous adipose tissue
timeFrame: Change from baseline to 12 weeks
measure: Change in visceral adipose tissue
timeFrame: Change from 12 weeks of intervention to 12 months
measure: Change in abdominal subcutaneous adipose tissue
timeFrame: Change from 12 weeks of intervention to 12 months
measure: Change in pancreatic fat content
timeFrame: Change from baseline to 12 weeks
measure: Change in pancreatic fat content
timeFrame: Change from 12 weeks of intervention to 12 months
measure: Change in intramuscular fat content
timeFrame: Change from baseline to 12 weeks
measure: Change in intramuscular fat content
timeFrame: Change from 12 weeks of intervention to 12 months
measure: Change in values of fasting glucose
timeFrame: Change from baseline to 12 weeks
measure: Change in HOMA-IR index.
timeFrame: Change from baseline to 12 weeks
measure: Change in values of HbA1c
timeFrame: Change from baseline to 12 weeks
measure: Change in values of fasting triglycerides
timeFrame: Change from baseline to 12 weeks
measure: Change in values of fasting high-density lipoprotein cholesterol
timeFrame: Change from baseline to 12 weeks
measure: Change in values of fasting low-density lipoprotein cholesterol
timeFrame: Change from baseline to 12 weeks
measure: Change in values of fasting total cholesterol
timeFrame: Change from baseline to 12 weeks
measure: Change in values of C-reactive protein
timeFrame: Change from baseline to 12 weeks
measure: Change in values of interleukin 6
timeFrame: Change from baseline to 12 weeks
measure: Change in values of creatinine
timeFrame: Change from baseline to 12 weeks
measure: Change in values of creatine kinase
timeFrame: Change from baseline to 12 weeks
measure: Change in values of iron
timeFrame: Change from baseline to 12 weeks
measure: Change in values of ferritin
timeFrame: Change from baseline to 12 weeks
measure: Change in values of folic acid
timeFrame: Change from baseline to 12 weeks
measure: Change in values of apolipoprotein A1
timeFrame: Change from baseline to 12 weeks
measure: Change in values of apolipoprotein B
timeFrame: Change from baseline to 12 weeks
measure: Change in levels of mean glucose (Continuous Glucose Monitoring)
timeFrame: Change from baseline to the last 2 weeks of intervention
measure: Change in quantitative insulin-sensitivity check index
timeFrame: Change from baseline to the last 2 weeks of intervention
measure: Change in Body weight
timeFrame: Change from baseline to 12 weeks
measure: Change in Body weight
timeFrame: Change from 12 weeks of intervention to 12 months
measure: Change in Body height
timeFrame: Change from baseline to 12 weeks
measure: Change in Body height
timeFrame: Change from 12 weeks of intervention to 12 months
measure: Change in fat mass
timeFrame: Change from baseline to 12 weeks
measure: Change in fat free mass
timeFrame: Change from baseline to 12 weeks
measure: Change in bone mineral density
timeFrame: Change from baseline to 12 weeks
measure: Change in fat mass
timeFrame: Change from 12 weeks of intervention to 12 months
measure: Change in fat free mass
timeFrame: Change from 12 weeks of intervention to 12 months
measure: Change in bone mineral density
timeFrame: Change from 12 weeks of intervention to 12 months
measure: Change in waist circumference
timeFrame: Change from baseline to 12 weeks
measure: Change in calf girth
timeFrame: Change from baseline to 12 weeks
measure: Change in waist circumference
timeFrame: Change from 12 weeks of intervention to 12 months
measure: Change in calf girth
timeFrame: Change from 12 weeks of intervention to 12 months
measure: Change in hip circumference
timeFrame: Change from baseline to 12 weeks
measure: Change in hip circumference
timeFrame: Change from 12 weeks of intervention to 12 months
measure: Change in neck circumference
timeFrame: Change from baseline to 12 weeks
measure: Change in neck circumference
timeFrame: Change from 12 weeks of intervention to 12 months
measure: Change in systolic blood pressure
timeFrame: Change from baseline to 12 weeks
measure: Change in systolic blood pressure
timeFrame: Change from 12 weeks of intervention to 12 months
measure: Change in diastolic blood pressure
timeFrame: Change from baseline to 12 weeks
measure: Change in diastolic blood pressure
timeFrame: Change from 12 weeks of intervention to 12 months
measure: Change in energy intake
timeFrame: Change from baseline to 12 weeks
measure: Change in carbohydrates intake
timeFrame: Change from baseline to 12 weeks
measure: Change in fat intake
timeFrame: Change from baseline to 12 weeks
measure: Change in protein intake
timeFrame: Change from baseline to 12 weeks
measure: Change in dietary habits
timeFrame: Change from baseline to 12 weeks
measure: Change in Appetite traits
timeFrame: Change from baseline to 12 weeks
measure: Change in Subjective sleep quality
timeFrame: Change from baseline to 12 weeks
measure: Change in Objectively sleep quality
timeFrame: Change from baseline to 12 weeks
measure: Change in Chronotype
timeFrame: Change from baseline to 12 weeks
measure: Change in Morning-Evening type
timeFrame: Change from baseline to 12 weeks
measure: Change Objectively moderate to vigorous physical activity levels
timeFrame: Change from baseline to 12 weeks
measure: Change in Depression aspects
timeFrame: Change from baseline to 12 weeks
measure: Change in Stress aspects
timeFrame: Change from baseline to 12 weeks
measure: Change in Anxiety aspects
timeFrame: Change from baseline to 12 weeks
measure: Change in General health
timeFrame: Change from baseline to 12 weeks
measure: Change in Quality of life
timeFrame: Change from baseline to 12 weeks
measure: Change in Gut microbiota composition
timeFrame: Change from baseline to 12 weeks
measure: Change in fecal microbiota diversity
timeFrame: Change from baseline to 12 weeks
measure: Change in Cardiorespiratory Fitness
timeFrame: Change from baseline to 12 weeks
measure: Change in Lower muscular strength
timeFrame: Change from baseline to 12 weeks
measure: Change in Upper muscular strength
timeFrame: Change from baseline to 12 weeks
measure: Change in walking speed.
timeFrame: Change from baseline to 12 weeks
measure: Adherence to the time-restricted eating intervention
timeFrame: Change from baseline to 12 weeks
measure: Adherence to the exercise intervention
timeFrame: Change from baseline to 12 weeks
measure: Change in hepatic fat content
timeFrame: Change from 12 weeks of intervention to 12 months
Other outcomes:
Locations:
city: Granada
country: Spain
facility: University of Granada - Instituto Mixto Universitario Deporte y Salud
city: Granada
country: Spain
facility: University of Granada
Study officials:
affiliation: Universidad de Granada
name: Jonatan R. Ruiz, PhD
role: PRINCIPAL_INVESTIGATOR
References: