NCT05897073已完成不适用
Impact of Time-Restricted Eating and Supervised Exercise on Hepatic Steatosis and Cardiometabolic Health in Adults With Obesity
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 187
- 试验地点
- 4
- 主要终点
- Change in hepatic fat content
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in hepatic fat content
时间窗: Change from baseline to 12 weeks
Hepatic fat content will be assessed by Magnetic Resonance Imaging (MRI)
次要结局
- 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)
研究者
Jonatan Ruiz Ruiz
Professor
Universidad de Granada
研究点 (4)
Loading locations...
相似试验
已完成
不适用
Efficacy and Feasibility of Time-restricted Eating on Cardiometabolic Health in Adults With Overweight/ObesityTime Restricted FeedingObesity, AbdominalCardiometabolic SyndromeNCT05310721Universidad de Granada197
Unknown
不适用
Identification of Biomarkers of Response After Bariatric Surgery in Morbidly Obese PatientsMorbid ObesityNCT03784508Hospital Universitari Vall d'Hebron Research Institute200
招募中
不适用
The Effect of Time-Restricted Feeding on Body Composition and Some Metabolic Parameters in Obese AdolescentsAdolescent ObesityNCT06616454Sümeyra Başar60
已完成
不适用
Contraception and Bariatric Surgery: Evaluation of Contraception and Contraceptive Knowledge of Women Undergoing Bariatric Surgery at the University Hospital of ReimsBariatric Surgery CandidateNCT04219852CHU de Reims100
进行中（未招募）
不适用
Time-restricted Eating Versus Daily Continuous Calorie Restriction on Body Weight and Colorectal Cancer Risk MarkersTime Restricted EatingWeight LossObesityColorectal CancerNCT05114798University of Illinois at Chicago194