Clinical Intervention of Idecalcitol Combined With Whey Protein Powder and Exercise for Sarcopenia：a RCT Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 450
- 试验地点
- 5
- 主要终点
- muscle mass
研究概览
简要总结
This clinical trial is a multicenter, single-blind, prospective, randomized controlled clinical application study. Subjects who met the trial criteria and signed the informed consent form were randomly divided into a control group, an experimental group 1, and an experimental group 2. After enrollment, the control group underwent a comprehensive assessment of their underlying conditions by professional physicians and received routine interventions, including basic nutritional intervention program guidance, progressive resistance exercise intervention program guidance, safety precautions, and symptomatic treatment for different complications, for a total intervention period of 24 weeks. The experimental group 1, in addition to the interventions provided to the control group, received whey protein powder supplementation for 12 weeks. The experimental group 2, on the other hand, received both whey protein powder and eldecalcitol supplementation on top of the interventions given to the control group, also for 12 weeks. The entire intervention period lasted for 24 weeks. Through regular general assessments, blood tests, measurements of muscle mass, muscle strength, and physical function, as well as analyses of negative adverse events, statistical methods were employed to evaluate the safety and efficacy of the comprehensive intervention methods for sarcopenia.
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
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 30 or above;
- •Meeting the diagnostic criteria for sarcopenia according to the definition of AWGS; ③ Able to walk, willing to accept a comprehensive intervention plan, and guarantee to complete the treatment course; ④ Both patients and their families agree to participate in this study and sign the informed consent form.
排除标准
- •Resting systolic blood pressure > 200 mmHg or resting diastolic blood pressure > 100 mmHg;
- •Severe heart disease: moderate to severe aortic valve stenosis, acute pericarditis, acute myocarditis, myocardial infarction, uncontrollable arrhythmia;
- •Acute stroke within the past 2 years;
- •Severe airway obstruction;
- •Lower limb fractures in the past 1 year or upper limb fractures in the past 6 months;
- •Hypercalcemia (corrected albumin serum calcium > 2.60 mmol/L);
- •Active malignant tumors; ⑧ Chronic kidney disease stages 5;
- •Mental illness or severe cognitive impairment;
- •Long-term immobilization; ⑪ Other diseases that may interfere with the evaluation of muscle mass, muscle strength, and physical function; ⑫ Unable to cooperate with treatment due to other reasons; ⑬ Life expectancy less than 6 months.
研究组 & 干预措施
Control group
After enrollment, professional doctors will conduct a comprehensive assessment of their basic conditions and provide routine interventions, mainly including basic nutrition intervention program guidance, progressive resistance exercise intervention program guidance, safety protection advice, and symptomatic treatment for different complications, with a total intervention period of 24 weeks.
干预措施: exercise (Behavioral)
experimental group 1
On the basis of the control group, whey protein powder was given to supplement for 12 weeks.60 grams of protein per day is taken in three divided doses for 12 consecutive weeks. Attention should be paid to monitoring liver and kidney function, and the dosage of protein powder should be adjusted according to the condition of the patient.
干预措施: exercise (Behavioral)
experimental group 1
On the basis of the control group, whey protein powder was given to supplement for 12 weeks.60 grams of protein per day is taken in three divided doses for 12 consecutive weeks. Attention should be paid to monitoring liver and kidney function, and the dosage of protein powder should be adjusted according to the condition of the patient.
干预措施: whey protein powder (Dietary Supplement)
experimental group 2
On the basis of the control group, whey protein powder and eldecalcitol were given for supplementation for 12 weeks.
(Supplementing whey protein powder: The protein intake is 60 grams per day, taken in three divided doses for 12 consecutive weeks. Attention should be paid to monitoring liver and kidney function, and the dosage of protein powder should be adjusted according to the condition of the patient.
Supplementing eldecalcitol: eldecalcitol soft gel capsules are taken at an oral dose of 0.75μg once a day for 12 consecutive weeks.)
干预措施: exercise (Behavioral)
experimental group 2
On the basis of the control group, whey protein powder and eldecalcitol were given for supplementation for 12 weeks.
(Supplementing whey protein powder: The protein intake is 60 grams per day, taken in three divided doses for 12 consecutive weeks. Attention should be paid to monitoring liver and kidney function, and the dosage of protein powder should be adjusted according to the condition of the patient.
Supplementing eldecalcitol: eldecalcitol soft gel capsules are taken at an oral dose of 0.75μg once a day for 12 consecutive weeks.)
干预措施: whey protein powder (Dietary Supplement)
experimental group 2
On the basis of the control group, whey protein powder and eldecalcitol were given for supplementation for 12 weeks.
(Supplementing whey protein powder: The protein intake is 60 grams per day, taken in three divided doses for 12 consecutive weeks. Attention should be paid to monitoring liver and kidney function, and the dosage of protein powder should be adjusted according to the condition of the patient.
Supplementing eldecalcitol: eldecalcitol soft gel capsules are taken at an oral dose of 0.75μg once a day for 12 consecutive weeks.)
干预措施: Eldecalcitol (Drug)
结局指标
主要结局
muscle mass
时间窗: up to 24 weeks
The DXA equipment is used to detect the muscle mass.
次要结局
- Grip strength(up to 24 weeks)
- 6-meter walking speed(up to 24 weeks)
- incidence of adverse reactions(up to 24 weeks)