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Clinical Trials/NCT05897073
NCT05897073CompletedNot Applicable

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

Universidad de Granada4 sites in 1 country187 target enrollmentStarted: May 2, 2023Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
187
Locations
4
Primary Endpoint
Change in hepatic fat content
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
25 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Aged 25-65 years.
  • •Body mass index ≥28.0 and <40.0 kg/m
  • •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.

Outcomes

Primary Outcomes

Change in hepatic fat content

Time Frame: Change from baseline to 12 weeks

Hepatic fat content will be assessed by Magnetic Resonance Imaging (MRI)

Secondary Outcomes

  • Change in liver stiffness(Change from baseline to 12 months)
  • Change in values of alkaline phosphatase(Change from baseline to 12 months)
  • Change in values of alanine transaminase(Change from baseline to 12 months)
  • Change in visceral adipose tissue(Change from baseline to 12 months)
  • Change in values of gamma-glutamyl transferase(Change from baseline to 12 months)
  • Change in abdominal subcutaneous adipose tissue(Change from baseline to 12 months)
  • Change in pancreatic fat content(Change from baseline to 12 months)
  • Change in values of fasting glucose(Change from baseline to 12 months)
  • Change in HOMA-IR index.(Change from baseline to 12 months)
  • Change in values of HbA1c(Change from baseline to 12 months)
  • Change in values of fasting high-density lipoprotein cholesterol(Change from baseline to 12 months)
  • Change in values of fasting triglycerides(Change from baseline to 12 months)
  • Change in values of fasting low-density lipoprotein cholesterol(Change from baseline to 12 months)
  • Change in values of fasting total cholesterol(Change from baseline to 12 months)
  • Change in values of C-reactive protein(Change from baseline to 12 months)
  • Change in values of interleukin 6(Change from baseline to 12 months)
  • Change in values of apolipoprotein A1(Change from baseline to 12 months)
  • Change in values of apolipoprotein B(Change from baseline to 12 months)
  • Change in Body weight(Change from baseline to 6 weeks)
  • Change in levels of mean glucose (Continuous Glucose Monitoring)(Change from baseline to the last 2 weeks of intervention)
  • Change in 2-hour plasma glucose(Change in 2-hour plasma glucose baseline and 12 weeks)
  • Change in Body height(Change from baseline to 12 months)
  • Change in waist circumference(Change from baseline to 6 weeks)
  • Change in calf girth(Change from baseline to 6 weeks)
  • Change in diastolic blood pressure(Change from baseline to 12 months)
  • Change in hip circumference(Change from baseline to 6 weeks)
  • Change in neck circumference(Change from baseline to 6 weeks)
  • Change in systolic blood pressure(Change from baseline to 12 months)
  • Change in energy intake(Change from baseline to 6 weeks)
  • Change in carbohydrates intake(Change from baseline to 6 weeks)
  • Change in dietary habits(Change from baseline to 12 weeks)
  • Change in fat intake(Change from baseline to 6 weeks)
  • Change in protein intake(Change from baseline to 6 weeks)
  • Change in Appetite traits(Change from baseline to 12 weeks)
  • Change in Subjective sleep quality(Change from baseline to 12 weeks)
  • Change in Objectively sleep quality(Change from baseline to 12 weeks)
  • Change in Chronotype(Change from baseline to 12 weeks)
  • Change in Morning-Evening type(Change from baseline to 12 weeks)
  • Change Objectively moderate to vigorous physical activity levels(Change from baseline to 12 weeks)
  • Change in Depression aspects(Change from baseline to 12 weeks)
  • Change in Stress aspects(Change from baseline to 12 weeks)
  • Change in Anxiety aspects(Change from baseline to 12 weeks)
  • Change in General health(Change from baseline to 12 weeks)
  • Change in Cardiorespiratory Fitness(Change from baseline to 12 weeks)
  • Change in Quality of life(Change from baseline to 12 weeks)
  • Change in fecal microbiota composition(Change from baseline to 12 weeks)
  • Change in mid-thigh intermuscular fat content(Change from baseline to 12 months)
  • Change in values of aspartate aminotransferase(Change from baseline to 12 months)
  • Change in fecal microbiota diversity(Change from baseline to 12 weeks)
  • Adherence to the eating window(During the 12 weeks)
  • Attendance to the exercise intervention(During the 12 weeks)
  • Change in Lower muscular strength(Change from baseline to 12 weeks)
  • Change in Upper muscular strength(Change from baseline to 12 weeks)
  • Change in walking speed.(Change from baseline to 12 weeks)
  • Change in hepatic fat content(Change from baseline to 12 months)
  • Change in abdominal intermuscular fat content(Change from baseline to 12 months)
  • Change in abdominal skeletal muscle tissue(Change from baseline to 12 weeks)
  • Change in mid-thigh subcutaneous adipose tissue(Change from baseline to 12 months)
  • Change in Fat Mass(Change from baseline to 6 weeks)
  • Change in values of non-essential amino acids(Change from baseline to 12 weeks)
  • Change in mid-thigh intramuscular fat content(Change from baseline to 12 months)
  • Change in values of essential amino acids(Change from baseline to 12 weeks)
  • Change in steps counts(Change from baseline to the last 2 weeks of intervention)
  • Change in fecal microbiota functionality(Change from baseline to 12 weeks)
  • Change in mid-thigh skeletal muscle tissue(Change from baseline to 12 months)
  • Change in liver steatosis(Change from baseline to 12 months)
  • Change in liver viscosity(Change from baseline to 12 months)
  • Change in Fat-free Mass(Change from baseline to 6 weeks)
  • Change in Bone Mineral Density(Change from baseline to 6 weeks)
  • Change in rest-activity rhythms(Change from baseline to the last 2 weeks of intervention)
  • Change in values of fasting insulin(Change from baseline to 12 months)
  • Change in fiber intake(Change from baseline to 6 weeks)
  • Change in adherence to Mediterranean diet(Change from baseline to 12 months)
  • Change in values of fasting total cholesterol(Change from baseline to 12 weeks)
  • Change in carbohydrates intake(Change from baseline to 12 weeks)
  • Change in fat intake(Change from baseline to 12 weeks)
  • Change in protein intake(Change from baseline to 12 weeks)
  • Change in Depression aspects(Change from baseline to 12 weeks)
  • Change in Stress aspects(Change from baseline to 12 weeks)
  • Change in Anxiety aspects(Change from baseline to 12 weeks)
  • Change in General health(Change from baseline to 12 weeks)
  • Change in Quality of life(Change from baseline to 12 weeks)
  • Change in dietary habits(Change from baseline to 12 weeks)
  • Change in Appetite traits(Change from baseline to 12 weeks)
  • Change in Subjective sleep quality(Change from baseline to 12 weeks)
  • Change in Objectively sleep quality(Change from baseline to 12 weeks)
  • Change in Chronotype(Change from baseline to 12 weeks)
  • Change in Morning-Evening type(Change from baseline to 12 weeks)
  • Change Objectively moderate to vigorous physical activity levels(Change from baseline to 12 weeks)
  • Change in levels of mean glucose (Continuous Glucose Monitoring)(Change from baseline to the last 2 weeks of intervention)
  • Change in energy intake(Change from baseline to 12 weeks)
  • Change in values of alkaline phosphatase(Change from baseline to 12 weeks)
  • Change in values of alanine transaminase(Change from baseline to 12 weeks)
  • Change in values of gamma-glutamyl transferase(Change from baseline to 12 weeks)
  • Change in values of fasting glucose(Change from baseline to 12 weeks)
  • Change in HOMA-IR index.(Change from baseline to 12 weeks)
  • Change in values of HbA1c(Change from baseline to 12 weeks)
  • Change in values of fasting triglycerides(Change from baseline to 12 weeks)
  • Change in values of fasting high-density lipoprotein cholesterol(Change from baseline to 12 weeks)
  • Change in values of fasting low-density lipoprotein cholesterol(Change from baseline to 12 weeks)
  • Change in values of C-reactive protein(Change from baseline to 12 weeks)
  • Change in values of interleukin 6(Change from baseline to 12 weeks)
  • Change in values of apolipoprotein A1(Change from baseline to 12 weeks)
  • Change in values of apolipoprotein B(Change from baseline to 12 weeks)
  • Change in fecal microbiota diversity(Change from baseline to 12 weeks)
  • Change in Cardiorespiratory Fitness(Change from baseline to 12 weeks)
  • Change in Lower muscular strength(Change from baseline to 12 weeks)
  • Change in Upper muscular strength(Change from baseline to 12 weeks)
  • Change in walking speed.(Change from baseline to 12 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jonatan Ruiz Ruiz

Professor

Universidad de Granada

Study Sites (4)

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