Effectiveness of a Rehabilitation Program (Nutritional + Physical Activity) in Sarcopenic Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change of Homa index
研究概览
简要总结
The obese patient presents a quantitative and qualitative deficit of muscle mass as occurs in the elderly subject that was named Sarcopenic Obesity (SO). The use of a diet that includes protein supplements and / or essential amino acids seems to improve this condition in the elderly; there are no similar studies in obese subjects, in particular during a low-calorie diet and physical activity program that can produce further loss of muscle mass. This study aims to verify whether the administration of these supplements (protein or amino acid) in the obese patient are effective in improving anthropometric and functional parameters and some serum markers of muscle metabolism. The results obtained could represent new therapeutic protocols in the treatment of obesity.
详细描述
Several studies have confirmed that adequate nutrition, especially protein intake, including at breakfast, or supplementation with amino acids, in association with adequate physical activity plays an important role in the treatment of SO.
The supplementation of protein or amino acid preparations (in particular with the 9 essential amino acids including, the branched - leucine, isoleucine, valine), marketed in different formulations, has already allowed to document a significant therapeutic efficacy in the treatment of elderly sarcopenic subjects. In fact, the use of these preparations improves physical performance and muscle strength by inducing the synthesis of proteins involved in the biogenesis and functionality of mitochondria - that is, the cellular organelles responsible for the production of energy in the form of ATP - and of myofibrillar proteins (which constitute the large percentage of muscle mass), both in laboratory animals and in humans.
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
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •patients with obesity (BMI> 35kg / m2)
- •sarcopenia (criteria described in Coltorti A et al).
排除标准
- •renal insufficiency
- •muscular pathologies
- •neurological-neurodegenerative pathologies
- •cognitive decline
研究组 & 干预措施
Diet Arm
low-calorie diet normoproteic with an energy deficit of 15% compared to what emerged from the calorimetric value (basal REE)
干预措施: Diet (Other)
Protein Arm
low-calorie diet normoproteic + an integration of 8.72 g of protein in the form of a nutritional supplement (18-20% protein)
干预措施: Diet + protein (Dietary Supplement)
EAA Arm
low-calorie diet normoproteic + amino acid supplement (2 sachet/daily; 1 sachet contains protein 0 gr, carbohydrates 6.69 gr , lipids 0 gr, i-leucine 1,2 gr, i-isoleucine 0,6 gr, i-valine 0,6 gr).
干预措施: Diet + EAA (Dietary Supplement)
EAA + TCA
low-calorie diet normoproteic + an amino acid supplement (2 stick/daily; 1 stick pack contains protein 0 gr, carbohydrates 1,046 gr, lipids 0.074 gr, i-leucine 1.2 gr, i-isoleucine 0.6 gr, i-valine 0.6 gr, citric acid, succinic acid and malic acid)
干预措施: Diet + EAA and TCA (Dietary Supplement)
结局指标
主要结局
Change of Homa index
时间窗: basal and at 4 weeks
glycaemia and insulin will be combined to report Homa index in mmol/l/mU/l
Change of BMI
时间窗: basal and at 4 weeks
weight and height will be combined to report BMI in kg/m\^2
Change of Waist
时间窗: basal and at 4 weeks
waist circumference in centimeters
Change of TUG
时间窗: basal and at 4 weeks
time, in second, to up from the chair, walks 3 meters, turns around, walks back to the chair and sits down
Change of Height
时间窗: basal and at 4 weeks
height in meters
Change of Muscle strenght
时间窗: basal and at 4 weeks
muscle streght at the hand (right and left) in kg
Change of Insulin secretion
时间窗: basal and at 4 weeks
insulin pasma levels in mU/l
Change of Muscle function
时间窗: basal and at 4 weeks
irisin and procollagen type III N-terminal peptide (P3NP) in ng/ml
Change of FM
时间窗: basal and at 4 weeks
Fat Mass (FM) in % of body weight in kilograms
Change of FFM
时间窗: basal and at 4 weeks
Free Fat Mass (FFM) in % of body weight in kilograms
Change of MM
时间窗: basal and at 4 weeks
Muscle Mass (MM) in % of body weight in kilograms
Change of Metabolic profile
时间窗: basal and at 4 weeks
glycaemia, total cholesterol, LDL cholesterol, triglycerides all in mg/dl
Change of Body weight
时间窗: basal and at 4 weeks
weight in kilograms
Change of Walking
时间窗: basal and at 4 weeks
6 minute walk test (6MWT), meters walking in 6 minutes
Change of Muscle wasting
时间窗: basal and at 4 weeks
C-terminal agrin fragment (CAF) in pg/ml
次要结局
未报告次要终点
研究者
Amelia Brunani
Director of Clinical Unit
Istituto Auxologico Italiano