Dissecting the Therapeutic Mechanism of an Effective Combination Treatment Targeting Neuromuscular Junction Dengeneration and Myosteatosis to Combat Sarcopenia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Muscle performance-gait speed
研究概览
简要总结
The investigators' pre-clinical study confirms the positive effects of combined treatment (VT + HMB) on reducing fat-to-lean tissue ratio, intramuscular fat infiltration and increasing muscle strength in sarcopenia animal model. The results showed that fat mass could be decreased by ~32%, while histology Oil Red O staining indicated a decrease of fat by almost 60%; in contrast, lean muscle mass increased by ~14%. On muscle strength, combined treatment increased twitch force, tetanic force and grip strength by ~30-66%. These in vivo results are very encouraging and the investigators should explore its potential in clinical translation. As VT and HMB supplement have been commercially available and their compliance rates are satisfactory, they can be translated to clinical application easily. The investigators' next step is to confirm its clinical efficacy, so that sarcopenia becomes a new indication of VT and HMB. The hypothesis is that combined treatment of VT and HMB can retard the progression of sarcopenia in human, in terms of muscle mass, muscle strength and performance.
详细描述
In this study, a single-blinded RCT is to investigate the effect of combination treatment of VT and HMB on hand grip, gait speed, muscle mass (DXA) in sarcopenic subjects.
Subjects over age of 65 will be screened by performing SARC-F, handgrip, gait speed and bioelectric impedance assessment (BIA) based on AWGS definition. The participants failed in AWGS algorithm will be invited to join the research. Exclusion criteria are those with (1)pathological bone diseases, (2) chronic inflammatory conditions (e.g. rheumatoid arthritis), (3) neurological problems affecting gait, (4) taking regular supervised exercise training for more than 3 times/week, (5) chair-bound or bed-bound, and (6) malignancy.
Recruited subjects will be randomized to either (1) Control, (2) HMB only, (3) VT only or (4) HMB +VT group. All subjects will be given protein supplement to ensure minimal daily protein intake. Subject assigned to VT group will receive VT (35Hz, 0.3g, 20min/day, at least 3 times/week) for 6 months. Subjects assigned to HMB group will take HMB capsules 3g/day for 6 months. Subjects assigned to HMB+VT group will recieve both VT and HMB supplements for 6 months. The primary outcome is muscle strength showing subjects' functional ability. All primary and secondary outcome assessments for all groups will be performed in the investigators' institute at baseline, 3 months and 6 months post-treatment.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged 60 years or above
- •Subjects failed in AWGS algorithm
- •skeletal muscle mass by BIA (male at <7.0 kg/m^2, female at <5.7 kg/m^2), and
- •handgrip strength (male at <28 kg, female at <18kg), and/or
- •gait speed test (>1m/s)
排除标准
- •Subjects with pathological bone diseases
- •Subjects with chronic inflammatory condition (e.g. rheumatoid arthritis)
- •Subjects with neurological problems
- •Subjects receiving regular exercise
- •Subjecs who are chair-/bed- bound
- •Subjects with malignancy
- •Subjects with cardiovascular concern such as with pace-maker in-situ
- •Subjects with acute fractures or severe osteoarthritis
研究组 & 干预措施
Control Group
Subjects assigned to Contro Group will not receive VT or HMB. They will receive daily protein supplement for 6 months.
干预措施: Protein supplement (Dietary Supplement)
HMB only Group
Subjects assigned to HMB only Group will receive HMB supplement at 3g/day and daily protein supplement for 6 months.
干预措施: β-hydroxy β-methylbutyrate (HMB) supplement (Dietary Supplement)
HMB only Group
Subjects assigned to HMB only Group will receive HMB supplement at 3g/day and daily protein supplement for 6 months.
干预措施: Protein supplement (Dietary Supplement)
VT only Group
Subjects assigned to VT only Group will receive VT (0.3g, 35Hz, at least 3 times/week) and daily protein supplement for 6 months
干预措施: Low-magnitude High-frequency Vibration (Device)
VT only Group
Subjects assigned to VT only Group will receive VT (0.3g, 35Hz, at least 3 times/week) and daily protein supplement for 6 months
干预措施: Protein supplement (Dietary Supplement)
HMB + VT Group
Subjects assigned to HMB + VT Group will receive HMB supplement at 3g/day, VT at least 3 times/week and daily protein supplement for 6 months.
干预措施: Low-magnitude High-frequency Vibration (Device)
HMB + VT Group
Subjects assigned to HMB + VT Group will receive HMB supplement at 3g/day, VT at least 3 times/week and daily protein supplement for 6 months.
干预措施: β-hydroxy β-methylbutyrate (HMB) supplement (Dietary Supplement)
HMB + VT Group
Subjects assigned to HMB + VT Group will receive HMB supplement at 3g/day, VT at least 3 times/week and daily protein supplement for 6 months.
干预措施: Protein supplement (Dietary Supplement)
结局指标
主要结局
Muscle performance-gait speed
时间窗: 6 months
Gait speed will be assessed by a 6-meter-walk test.
Muscle strength-handgrip
时间窗: 6 months
Handgrip strength will be measured by a dynamometer on each hand of the subject.
次要结局
- Dual energy x-ray absortiometry (DXA)(6 months)
- Biodex Balance System-LOS(6 months)
- Time-up-and-go test (TUG)(6 months)
- Biodex Balance System-OSI(6 months)
- 36-item Short-Form Health Survey (SF-36)(6 months)
研究者
Professor CHEUNG Wing hoi, Louis
Professor
Chinese University of Hong Kong