Mapping Metabolic Organ Plasticity in Energy Adaptation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Change in Metabolic Adaptation
研究概览
简要总结
Brief Summary (Plain Language)
Many people who lose weight experience a slowdown in their metabolism that is greater than expected. This response, called metabolic adaptation, makes it harder to continue losing weight or to keep weight off over time. The biological reasons for this slowdown are not fully understood.
Some organs in the body, especially the liver and kidneys, use a large amount of energy even when the body is at rest. Although these organs make up only a small portion of body weight, they account for a large share of daily energy use. Changes in the size or function of these organs may play an important role in metabolic adaptation, but this has not been well studied in humans.
The purpose of this study is to understand how different lifestyle approaches affect metabolic adaptation and the size of key metabolic organs. Specifically, the study compares three common strategies:
- resistance training without calorie restriction,
- a calorie-restricted diet, and
- time-restricted eating (eating all daily food within a limited time window).
Adults with overweight will take part in one of these approaches for 10 weeks. Before and after the study period, participants will undergo advanced measurements, including magnetic resonance imaging (MRI) scans to measure liver and kidney size, tests to measure resting metabolism, and assessments of body composition. Some participants will also undergo additional testing to measure daily energy use.
By understanding how different lifestyle strategies influence metabolism and organ size, this study aims to improve knowledge about why weight loss is difficult to maintain and to support the development of more personalized approaches to long-term weight management.
详细描述
Metabolic adaptation refers to a reduction in resting energy expenditure that is greater than what would be predicted from changes in body weight or body composition. This phenomenon is commonly observed during weight loss and is believed to contribute to weight regain. While metabolic adaptation is well documented, the underlying physiological mechanisms remain unclear.
Highly metabolic organs, including the liver and kidneys, consume a disproportionate amount of energy at rest. Emerging evidence suggests that reductions in the size of these organs during energy deficit states may contribute to declines in resting metabolic rate. However, few human studies have directly examined how different lifestyle interventions influence organ size and how these changes relate to metabolic adaptation.
This study is a 10-week, open-label, lifestyle intervention trial conducted in sedentary adults with overweight. Participants are assigned to one of three intervention groups: resistance training with a normal diet, calorie restriction, or time-restricted eating. All participants are supervised by qualified health professionals throughout the study.
Measurements are conducted before and after the intervention period and include gold-standard assessments of resting metabolic rate, body composition, liver and kidney volume using MRI, and hepatic fat content. A subset of participants undergoes doubly labeled water testing to assess total daily energy expenditure.
The primary goal of the study is to compare the degree of metabolic adaptation across the three lifestyle strategies. Secondary objectives include evaluating changes in liver and kidney volume and determining how these organ-level changes contribute to changes in metabolism. The study is designed to provide mechanistic insight into how exercise- and diet-based interventions influence energy regulation at the organ level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Sedentary men and women aged 25-60 years
- •Body mass index (BMI) of 25-35 kg/m²
排除标准
- •Participation in another exercise or weight loss program in the last 6 months
- •Non-stable weight (>±5%) over the past 6 months
- •Smoking within the past 6 months
- •Post-menopause
- •Breastfeeding
- •Pregnancy or having been pregnant within the past 6 months
- •Contraindication for MRI scans (e.g., tattoos, intrauterine devices, permanent makeup, etc.)
- •Severe cardiopulmonary disease (e.g., recent myocardial infarction or unstable angina)
- •Musculoskeletal or neuromuscular impairments that preclude exercise training
- •Cognitive impairments
- •Other health issues, including cancer, diabetes, thyroid disease, hypertension, or chronic renal failure
- •Use of drugs that affect body metabolism
- •Secondary liver disease (viral, autoimmune, alcoholic, or hepatotoxic)
- •Alcohol consumption above 20 g/day for women or 30 g/day for men
研究组 & 干预措施
Calorie Restriction
energy deficit of 500 Kcal/day
干预措施: Calorie Restriction (CR) (Behavioral)
Time Restricted Eating
fasting period (8 h eating window with 16 h of fasting).
干预措施: Resistance Training (RT) (Behavioral)
Resistance Training
Participants will train for 60 minutes, 3 times a week, using a full-body workout with nine exercises for a major muscle group.
干预措施: Time Restricted Eating (TRE) (Behavioral)
结局指标
主要结局
Change in Metabolic Adaptation
时间窗: Baseline to 10 weeks
Change in metabolic adaptation, defined as the difference between predicted resting metabolic rate and measured resting metabolic rate. Measurement: Resting metabolic rate measured by indirect calorimetry and predicted from body composition-based equations.
次要结局
- Change in Resting Metabolic Rate (RMR)(Baseline to 10 weeks)
- Change in Liver Volume(Baseline to 10 weeks)
- Change in Kidney Volume(Baseline to 10 weeks)
- Association Between Organ Volume Changes and Metabolic Adaptation(Baseline to 10 weeks)
研究者
Gepner Yftach
Principal Investigator - Prof.
Tel Aviv University