Study on the Metabolic Effects of a Diet Replaced With Essential Amino Acids and Carboxylic Acids (EAA-AC) in Patients With Severe Obesity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Muscle mass
研究概览
简要总结
The effectiveness of low-protein diets supplemented with essential aminoacid (EAA) formulas in genetic disorders of amino acid (AA) catabolism, such as maple syrup urine disease (MSUD), is widely recognized (Blackburn PR et al. 2017). The main aim of the present study is to evaluate a difference in the effectiveness of a multidisciplinary rehabilitation program in patients with high degree of obesity with and without supplementation of this new formula of amino acids (essential + tricarboxylic acids - EAA-AC). For this reason, patients of both sexes, aged between 45 and 65, suffering from high-grade obesity will be recruited in Piancavallo. The enrolled patients divided, randomly, into two groups will be given: EAA-AC group a low-calorie and low-protein diet integrated with 4 sachets of EAA-AC supplement per day; the control group will follow a low-calorie and low-protein diet only with placebo. The parameters considered, after two weeks of treatment, will be: weight loss; the maintenance/recovery of muscle mass assessed through changes in body composition and functional tests (Hand grip, 6MWT or TUG) but also through the analysis of mitochondrial function in PBMC and circulating levels of mtDNA; the improvement of the glucose picture and the lipid profile.
1 month after discharge, patients will carry out an outpatient check-up to evaluate the maintenance of muscle mass using impedance testing.
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
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obesity (BMI >35kg/m2)
排除标准
- •Type 2 diabetes mellitus
- •Renal failure
- •Heart failure (New York Heart Association NYHA, class IV)
- •Liver cirrhosis
- •Neoplasms
- •Muscular or non-autonomic pathologies
- •Neurological-neurodegenerative pathologies
- •Cognitive decline
- •Non-menopausal women.
- •Patients who have undergone bariatric surgery in the previous 12 months
- •Patients on pharmacological treatment for weight loss in the last three weeks
- •Patients using vitamin and amino acid supplements in the last three weeks
- •Patients on hormone therapy (e.g. L-thyroxine, testosterone).
研究组 & 干预措施
Aminoacids
Patients with obesity treated with essential aminoacids (EAA-AC)
干预措施: Aminoacid supplementation (Dietary Supplement)
Control
Patients with obesity treated with placebo
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Muscle mass
时间窗: At baseline and at 2 weeks after start of intervention
Change in muscle mass during weight loss assessed through changes in body composition
次要结局
- 6 minute walking test (6MWT)(At baseline and at 2 weeks after start of intervention)