Effects of Normobaric Hypoxia Aerobic Training in People With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Body mass (kg)
研究概览
简要总结
Altitude training has been suggested to be of potential support to improve some chronic clinical conditions, especially metabolic conditions. Normobaric hypoxia represents a promising system to simulate altitude training, and its efficacy and safety have been suggested in different conditions, including diabetes, obesity and hypertension. Metabolic dysfunction-associated steatotic liver disease (MASLD) can characterized by metabolic alterations (including altered body composition, lipid and glycemic profile, etc.), and might benefit from aerobic training performed in simulated altitude training (i.e., normobaric hypoxia). Mild altitude training will be proposed (equal to about 2'500 m, 15% FiO2) and compared to a sham normobaric normoxia condition, during a 6-week 3 times per week 50-min aerobic training (walking) at 60-65% of maximum heart rate (HRmax). Cardiorespiratory fitness, body composition, and metabolic profile will be investigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being diagnosed with MASLD from at the least 3 years
- •BMI > 26 kg/m2
- •Being sedentary
排除标准
- •Cardiovascular, respiratory, renal complications
- •Hypertension
- •Previous history of acute mountain sickness or altitude-associated symptoms
- •Females only: pregnancy or breastfeeding
研究组 & 干预措施
HYPOTRAIN
This arm will perform the normobaric hypoxic aerobic training (HYPOTRAIN)
干预措施: HYPOTRAIN (Other)
NORMOTRAIN
This arm will perform the normobaric normoxia aerobic training (NORMOTRAIN)
干预措施: NORMOTRAIN (Other)
结局指标
主要结局
Body mass (kg)
时间窗: At the beginning of the study and after 8 weeks of training
Evaluation of changes in body mass measured on a scale
Fat mass (%)
时间窗: At the beginning of the study and after 8 weeks of training
Evaluation of changes in fat mass, as percentage of body mass, assessed with bioimpedence (BIA)
次要结局
- Liver markers(At the beginning of the study and after 8 weeks of training)
- Maximum oxygen uptake (mL/kg*min)(At the beginning of the study and potentially after 8 weeks of training)
- Ventilatory threshold (mL/kg*min)(At the beginning of the study and potentially after 8 weeks of training)
- Triglyceride (mg/dL)(At the beginning of the study and after 8 weeks of training)
- Total cholesterol (mg/dL)(At the beginning of the study and after 8 weeks of training)
- High-density lipoprotein (mg/dL)(At the beginning of the study and after 8 weeks of training)
- Low-density lipoprotein (mg/dL)(At the beginning of the study and after 8 weeks of training)
- C-reactive protein (mg/dL)(At the beginning of the study and after 8 weeks of training)
- Glycemia (mg/dL)(At the beginning of the study and after 8 weeks of training)
- Insulinemia (mg/dL)(At the beginning of the study and after 8 weeks of training)
研究者
Alex Buoite Stella
PhD, Assistant Professor
University of Trieste