Improvement of Skeletal and Muscle Health in Patients With Sarcopenia by AIBEN YUEDONG Protein Nutrition Powder in Combination With a Resistance Exercise Intervention
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- Extremity Skeletal Muscle Mass Index (ASMI)
研究概览
简要总结
Sarcopenia is an age-related progressive skeletal muscle disease, the prevalence of which is increasing year by year with the aging of China's population, seriously affecting the health and quality of life of the elderly. Relevant studies have shown that protein intake in combination with resistance exercise can significantly improve muscle mass and function, and the effect is superior to that of a single intervention. In addition, ingredients such as vitamin D, N-acetylglucosamine, sodium hyaluronate, and taurine can further promote muscle health by regulating metabolism and inflammation levels. However, there are relatively few intervention studies combining the above nutrients with resistance exercise in patients with sarcopenia. Therefore, this study intends to use protein powder containing milk protein, vitamin D, N-acetylglucosamine, sodium hyaluronate, taurine and other ingredients, combined with low-intensity resistance exercise, to intervene in the middle-aged and elderly patients with sarcopenia, and to explore and observe the effects on muscle mass, bone density, intestinal health and other indexes of patients with sarcopenia, with the aim of providing a more accurate nutritional and exercise intervention program for the prevention and treatment of sarcopenia.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the diagnostic criteria for sarcopenia AWGS 2019
- •Grip strength less than 28.0 kg for males and less than 18.0 kg for females
- •6-meter stride speed less than 1.0 m/s or 5-repetition sit-up test time ≥ 12 seconds or SPPB ≤ 9 points.
- •Bioelectrical Impedance Analysis (BIA) less than 7.0 kg/m² for males and 5.7 kg/m² for females or Dual-energy X-ray absorptiometry (DXA) less than 7.0 kg/m² for males and 5.4 kg/m² for females;
- •Age between 35-75 years old with high compliance;
- •Complete clinical data;
- •Voluntary participation in the program with informed consent and signing of the informed consent form.
排除标准
- •A clear history of allergy to protein powder in the past 6 months, or the presence of diarrhea symptoms and the frequency of ≥ 7 days / month, the duration of more than 2 weeks;
- •Major physical diseases (diabetes with serious complications, malignant tumors, serious cardiovascular disease, neurological diseases or other diseases that may affect the effectiveness of exercise and nutritional interventions, etc.);
- •The past three months, new fractures and recently underwent joint replacement surgery patients;
- •Suffering from congenital bone or muscle diseases;
- •The simultaneous existence of other comorbidities affecting muscle metabolism, such as malignant tumors, liver disease, severe organ insufficiency such as nephrotic syndrome, renal failure and other diseases that may affect protein metabolism;
- •Participating in other clinical trials patients;
- •With sensory disabilities or other reasons significantly affecting the collection of data, such as severe deafness, blindness, mental disorders, etc.;
- •The researchers The researchers believe that other reasons are not suitable for clinical trials.
研究组 & 干预措施
Protein powder intervention group
干预措施: Protein powder intervention (Dietary Supplement)
Resistance exercise+placebo control group
干预措施: Resistance exercise intervention (Behavioral)
Resistance exercise+placebo control group
干预措施: Placebo control (Dietary Supplement)
Resistance exercise + protein powder intervention group
干预措施: Protein powder intervention (Dietary Supplement)
Resistance exercise + protein powder intervention group
干预措施: Resistance exercise intervention (Behavioral)
Placebo control group
干预措施: Placebo control (Dietary Supplement)
结局指标
主要结局
Extremity Skeletal Muscle Mass Index (ASMI)
时间窗: Baseline, month 3, month 6
ASM was measured using BIA, ASMI=ASM/height (m)\^2.
Handgrip strength
时间窗: Baseline, month 3, month 6
Maximum force grip was held for 3 seconds, the right and left hands were measured alternately, 3 measurements were taken in each hand, and the maximum value was taken.
6m walking speed
时间窗: Baseline, month 3, month 6
Let the tester start from the starting point, walk 6 meters at normal walking speed, stop when reaching the end point, record the time used, and calculate the 6m walking speed according to the time used and the distance of 6 meters.
Chair sitting and standing test
时间窗: Baseline, month 3, month 6
The subject sat in the center of the chair, crossed his/her arms in front of his/her chest, and after hearing the command "start", he/she completed 5 consecutive times of standing up and sitting down, and recorded the total time in seconds.
Simple Physical Performance Battery (SPPB)
时间窗: Baseline, month 3, month 6
The SPPB consists of 3 test items, each item is scored out of 4 points, and the total score is 12.
次要结局
- Height(Baseline, month 3, month 6)
- Weight(Baseline, month 3, month 6)
- Body Mass Index(BMI)(Baseline, month 6)
- General survey(Baseline, month 6)
- Sleep assessment(Baseline, month 3, month 6)
- Blood lipid concentration(Baseline, month 6)
- Insulin concentration(Baseline, month 6)
- Waist circumference, hip circumference, and waist to hip ratio(Baseline, month 3, month 6)
- Body composition(Baseline, month 6)
- Knee joint ultrasound(Baseline, month 6)
- Analysis of dietary intake(Baseline, month 6)
- Assessment of overall cognitive functioning(Baseline, month 6)
- Assessment of ability to perform activities of daily living(Baseline, month 3, month 6)
- Knee injury and osteoarthritis outcome score (KOOS score)(Baseline, month 3, month 6)
- Serum sarcopenia related factors(Baseline, month 6)
- Detection of intestinal flora species, quantity and differentiation level in human population(month 6)
- Bone density(Baseline, month 6)
- Blood glucose concentration(Baseline, month 6)
- Inflammation-related biochemical indicators(month 6)
研究者
Weiwei Ma
professor
Capital Medical University