Optimization of the Preservation of Muscle Mass and / or Its Recovery by a Protein-energy Chrononutrition Approach Dissociated From Meals
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 3
- 主要终点
- Appendicular lean body mass (gramme)
研究概览
简要总结
Muscle wasting has a multifactorial origin, including decreased physical activity, malnutrition, loss of post-incident muscle recovery abilities, and decreased ability to regenerate muscle. Among the strategies tested to improve the production of proteins and thus muscle is the supplementation of whey proteins. However this strategy does not seem sufficient and optimal to avoid muscle wasting and it must be complemented by a complementary action.
Muscle protein degradation also occurs during the nocturnal fasting periods to provide amino acids for energy purposes and to produce glucose, essential for vital organs. The preservation of the benefit of whey intake during meals could therefore be optimized by reducing the use of muscle proteins for energy purposes during the night.
详细描述
In this study, three arms will be studied for 3 months: 1 control group, 1 group with whey supplementation at lunch, and 1 group with whey supplementation at lunch and an energy bolus before bedtime. Actions include weight and body composition monitoring, nutritional status and muscle function, as well as mechanistic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Resident on the Accommodation Establishments for Dependent Elderly Persons on the Mutuality of Loire, France
- •Risk of undernutrition or moderate undernutrition with one of the following criteria :
- •Either 5-10% of weight loss in 1 month or 10-15% in 6 months.
- •Or Body Mass Index (BMI) between 16 and 21
- •Or Albumin levels between 30 and 35 g/L
- •Or global Mini Nutritional Assessment (MNA) test between 17 and 23.5
- •Or Short Emergency Geriatric Assessment (SEGA) Score >8
排除标准
- •Sub-acute pathology (flu, gastroenteritis, bacterial infections ...) or trauma (fracture, surgery ...) in the 30 days prior to inclusion.
- •Hepatocellular insufficiency
- •Heart failure with decompensation
- •Severe dementia,
- •Insulin-treated diabetes
- •Renal insufficiency (clearance <30 ml / min)
- •Long-term cortico-therapy
- •Cancer undergoing chemotherapy treatment or/and radiotherapy
- •Gastrointestinal pathology,
- •Diet incompatible with the nutritional protocol (intolerance to milk or lactose, vegetarians, vegans, ...)
- •Motor disability leading to the impossibility of doing muscle function tests.
结局指标
主要结局
Appendicular lean body mass (gramme)
时间窗: Days 0 and 90
Comparison appendicular lean body mass between the day of inclusion and 90 days after. It is measuring by Dual Energy X-ray Absorptiometry (DEXA).
次要结局
- Inflammatory status(Days 0, 45 and 90)
- Plasma albumin level (g/l)(Days 0, 45 and 90)
- Get up-and-go test (s)(Days 0 and 90)
- Frailty screening tool(Days 0 and 90)
- 6 minutes walk test (m)(Days 0 and 90)
- Profiles of the differential expression of potentials biomarkers(Days 0, 45 and 90)
- microbiota(Days 0 and 90)
- total body composition(Days 0, 45 and 90)
- Mini Nutritional Assessment score(Days 0 and 90)
- Hand Grip test (N)(Days 0 and 90)
- Maximal voluntary contraction of quadriceps (N)(Days 0 and 90)