A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Effects of Lactiplantibacillus Plantarum LM1001 on Muscle Strength in Older Adults.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in quadriceps and hamstring muscle strength (left and right)
研究概览
简要总结
Purpose:
This clinical trial aims to evaluate the efficacy and safety of Lactiplantibacillus plantarum LM1001 in improving muscle strength in older adults. The study is designed to investigate its potential effects on muscle strength based on the gut-muscle axis.
Methodology:
This study is a randomized, double-blind, placebo-controlled, single-center clinical trial. A total of 100 participants will be enrolled and randomly assigned to either the test group (n=50) or the placebo group (n=50). Participants in the test group will receive 500 mg of Lactiplantibacillus plantarum LM1001 (1.0 × 10¹⁰ CFU/day) once daily for 12 weeks, while those in the placebo group will receive a matching placebo.
Key Outcome Measures:
To evaluate the effects on muscle strength, the following parameters will be assessed at baseline and after the 12-week intervention period:
- Primary Outcome Measures: Changes in isokinetic knee extension and flexion strength.
- Secondary Outcome Measures: Changes in muscle strength-related parameters, including muscle power, skeletal muscle mass (SMM), and skeletal muscle mass index (SMI), as well as physical performance measures such as handgrip strength, Short Physical Performance Battery (SPPB) score, Timed Up and Go (TUG) test, and health-related quality of life assessed by EQ-5D-5L.
- Safety Assessments: Safety will be evaluated based on the incidence of adverse events, serum biochemical parameters, and clinical laboratory test results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants, care provider, investigators, and outcome assessors are blinded to the group allocation. The investigational product and placebo are identical in appearance, taste, and packaging.
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 50 to 84 years (male or female)
- •Body mass index (BMI) between 18.5 and 30.0 kg/m²
- •Reduced skeletal muscle mass (≤110% of standard value by BIA)
- •Decreased handgrip strength according to age- and sex-specific criteria
- •Short Physical Performance Battery (SPPB) score over 9
- •Able to perform normal physical activity and provide written informed consent
排除标准
- •Clinically significant acute or chronic diseases requiring treatment
- •Conditions affecting muscle function or physical performance (e.g., severe musculoskeletal, neurological, or cognitive disorders, including sarcopenia)
- •Significant gastrointestinal disorders or history of major gastrointestinal surgery
- •Severe psychiatric disorders or recent use of antipsychotic medications
- •Respiratory diseases affecting lung function
- •Excessive alcohol intake, substance abuse, or heavy smoking
- •Known hypersensitivity to the investigational product or its components
- •Recent use of medications or supplements affecting muscle function or gut microbiota (e.g., antibiotics, probiotics, steroids)
- •Regular high-intensity or resistance exercise
- •Clinically significant abnormal laboratory findings or uncontrolled medical conditions
- •Recent fractures within the past year
- •Participation in another clinical trial within 3 months prior to screening
- •Pregnant or breastfeeding women
- •Individuals unable to communicate or ambulate
- •Any other condition deemed unsuitable by the investigator
研究组 & 干预措施
Placebo control
Participants in this arm will take one placebo capsule (containing processed starch, etc.) identical in appearance to the test product, once daily in the morning before breakfast with sufficient water throughout the study period.
干预措施: Placebo (Dietary Supplement)
Lactiplantibacillus plantarum LM1001
Participants in this arm will take one capsule containing 500 mg of Lactiplantibacillus plantarum LM1001 (1.0 x 10^10 CFU/day) once daily, once daily in the morning before breakfast with sufficient water throughout the study period.
干预措施: Lactiplantibacillus plantarum LM1001 (Dietary Supplement)
结局指标
主要结局
Change in quadriceps and hamstring muscle strength (left and right)
时间窗: Baseline and Week 12
Change from baseline in quadriceps and hamstring muscle strength (left and right), measured using Biodex at an angular velocity of 60°/s.
次要结局
- Change in Muscle power(Baseline and Week 12)
- Change in Absolute skeletal muscle mass (SM)(Baseline and Week 12)
- Change in Appendicular skeletal muscle mass index (ASM/height²)(Baseline and Week 12)
- Change in Total body fat percentage(Baseline and Week 12)
- Change in ASM/weight × 100(Baseline and Week 12)
- Change in Skeletal muscle mass index (SMM/height²)(Baseline and Week 12)
- Change in Handgrip strength(Baseline and Week 12)
- Change in Serum prealbumin levels(Baseline and Week 12)
- Change in Short Physical Performance Battery (SPPB) score(Baseline and Week 12)
- Change in Timed Up and Go (TUG) test(Baseline and Week 12)
- Change in Serum creatinine levels(Baseline and Week 12)
- Change in Serum total protein levels(Baseline and Week 12)
- Change in Serum albumin levels(Baseline and Week 12)
- Change in Serum C-reactive protein (CRP) levels(Baseline and Week 12)
- Change in Serum creatine kinase (CK) levels(Baseline and Week 12)
- Change in Health-related quality of life assessed by EQ-5D-5L(Baseline and Week 12)