A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Effects of Oral Intake of HB05P on Improving Muscle Strength
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Isokinetic Knee Extension and Flexion Strength
研究概览
简要总结
This study aims to clinically and scientifically evaluate the safety of HB05P intake as a functional ingredient for health functional foods, as well as its efficacy in improving muscle strength.
This study is designed as a randomized, double-blind, placebo-controlled trial. Subjects who voluntarily agree to participate in the study by providing written informed consent will be screened according to the inclusion and exclusion criteria. Subjects who are taking health functional foods or medications that are judged not to affect the study outcomes may continue their use during the study. Eligible subjects will be randomly assigned in a 1:1 ratio to either the test group or the control group.
Randomized subjects will be instructed to perform walking and resistance (muscle-strengthening) exercises at least three times per week, for 30 minutes to 1 hour per session, until the end of the study period. Subjects will be required to complete an exercise diary. They will also receive the investigational product and a daily intake diary, and will consume the study product once daily according to the instructed method.
The quality of life questionnaire (EQ-5D-5L), exercise diary, and dietary intake assessed using the 24-hour recall method will be evaluated and compared between baseline and post-intervention. Efficacy and safety assessment variables will be measured and tested at Day 0 and Day 84, and the collected data will be statistically analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 60 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 60 years or older and younger than 80 years (male or female) who meet the inclusion criteria and do not meet any
排除标准
- •Body Mass Index (BMI) between 18.5 and 30.0 kg/m²
- •Skeletal muscle mass less than 110% of standard value measured by Bioelectrical Impedance Analysis (BIA)
- •Reduced handgrip strength in the dominant hand based on age- and sex-specific criteria: (Ages 60-69) Males ≤38.5 kg, Females ≤24.1 kg; (Ages 70-79) Males ≤33.2 kg, Females ≤20.9 kg
- •Capable of normal physical activity and voluntarily providing written informed consent to participate in this study
- •Exclusion Criteria:
- •History of bone fracture within the past 1 year
- •Serum creatinine greater than 2 times the upper limit of normal at the study site
- •AST (GOT) or ALT (GPT) greater than 2 times the upper limit of normal at the study site
- •Current diabetes mellitus or fasting blood glucose ≥126 mg/dL
- •Uncontrolled hyperthyroidism or hypothyroidism
- •Uncontrolled hypertension (blood pressure ≥160/100 mmHg)
- •Currently taking medication for psychiatric disorders (except for intermittent use for sleep disorders)
- •Participation in another drug clinical trial within 1 month prior to screening
- •Regular consumption (≥4 times/week) of probiotics or fermented dairy products (yogurt, cheese, etc.) within 2 weeks prior to screening
- •Use of medications or health functional foods related to muscle function within 1 month prior to screening (refer to prohibited concomitant medications)
- •History of gastrointestinal resection surgery (except appendectomy)
- •Pregnant or lactating women, or women planning to become pregnant during the study period
- •Known allergy to any component of the study product
- •History of alcohol abuse
- •Asthma or obstructive/restrictive pulmonary disease that may affect lung volume
- •Uncooperative attitude or any condition that, in the investigator's judgment, would make the participant unsuitable for the study
研究组 & 干预措施
HB05P
Pasteurized Akkermansia muciniphila HB05P, 3×10¹⁰ cells/day, once daily for 12 weeks
干预措施: HB05P (Pasteurized Akkermansia muciniphila) (Dietary Supplement)
Placebo
Placebo capsule containing crystalline cellulose, once daily for 12 weeks
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Change in Isokinetic Knee Extension and Flexion Strength
时间窗: Baseline and Week 12
Change from baseline in isokinetic muscle strength of quadriceps and hamstrings (both left and right) measured by Biodex dynamometer at angular velocity of 60°/s
次要结局
- Change in Isokinetic Muscle Power(Baseline and Week 12)
- Change in Appendicular Skeletal Muscle Mass (ASM)(Baseline and Week 12)
- Change in Skeletal Muscle Mass Index (SMMI)(Baseline and Week 12)
- Change in Body Fat Percentage(Baseline and Week 12)
- Change in Lower Extremity Muscle Mass(Baseline and Week 12)
- Change in Handgrip Strength(Baseline and Week 12)
- Change in Short Physical Performance Battery (SPPB) Score(Baseline and Week 12)
- Change in Serum IGF-1 Level(Baseline and Week 12)
- Change in Serum Myostatin Level(Baseline and Week 12)
- Change in Serum Follistatin Level(Baseline and Week 12)
- Change in Serum Nutritional Markers(Baseline and Week 12)
- Change in Health-Related Quality of Life(Baseline and Week 12)