NCT03848390Unknown不适用
Effect of Modified Time-restricted Feeding in Preventing Progression of Non-Alcoholic Fatty Liver Disease (NAFLD).
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in Alanine Amino Transferase (ALT) levels
研究概览
简要总结
The purpose of the study is to examine the effects of modified time-restricted feeding and conventional dietary approaches in motivated obese fatty liver patients on biochemical markers, imaging studies, and anthropometric measurements.
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
- None
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Motivated obese fatty liver patients aged 8 -18yrs with ALT >80
排除标准
- •Patients with metabolic disorders,
- •On certain medications (i.e., amiodarone, corticosteroids, methotrexate, select antipsychotics /antidepressants, HAART, valproic acid),
- •Kwashiorkor
- •Alcohol abuse,
- •Rapid surgical weight loss,
- •History of parenteral nutrition and
- •Hepatitis C.
结局指标
主要结局
Change in Alanine Amino Transferase (ALT) levels
时间窗: Baseline, 3 months
次要结局
- Change in Body Mass Index (BMI) Z-score(Baseline, 3 months)
- Change in hepatic steatosis on Magnetic Resonance Elastography of the Liver(Baseline, 3 months)
- Change in LDL(Baseline, 3 months)
- Change in TOTAL CHOLESTEROL(Baseline, 3 months)
- Fasting serum insulin(Baseline; 3 months)
- Change in fibrosis on Magnetic Resonance Elastography of the Liver(Baseline, 3 months)
- Change in diastolic blood pressure(Baseline, 3 months)
- Change in systolic blood pressure(Baseline, 3 months)
- Change in HDL(Baseline, 3 months)
- Change in TRIGLYCERIDE(Baseline, 3 months)
- Hemoglobin A1C(Baseline; 3 months)
- Fasting serum glucose(Baseline; 3 months)
研究者
Essam M. Imseis
Associate Professor
The University of Texas Health Science Center, Houston
研究点 (2)
Loading locations...
相似试验
Unknown
1 期
The Effect of Time-restricted Feeding on Physiological Function in Middle-aged and Older AdultsAgingNCT02970188University of Colorado, Boulder12
已完成
不适用
Time-Restricted Feeding Plus Resistance Training in Active FemalesHealthy Active FemalesNCT03404271Texas Tech University40
已完成
不适用
The Effect of Time-Restricted Feeding on Anthropometry, Biochemical Parameters, Diet Quality and Eating BehaviorFastingNCT05756868Eastern Mediterranean University40
已完成
不适用
The Impact of Time Restricted Feeding (TRF) in Improving the Health of Patients With Metabolic SyndromeWeight LossMetabolic SyndromeOverweight and ObesityNCT03182985University of California, San Diego35
已完成
不适用
Time-Restricted Feeding(TRF) on Overweight/Obese Women with Polycystic Ovarian Syndrome (PCOS)Polycystic Ovary Syndrome (PCOS)Overweight and ObesityNCT03792282The First Affiliated Hospital of Xiamen University93