The Effect of HB05P Supplementation on Muscle Strength Improvement: A Randomized, Double-blind, Controlled Preliminary Clinical Trial (HB05P-Muscle Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change from baseline in peak torque per body weight of the quadriceps and hamstrings (average of left and right)
研究概览
简要总结
The purpose of this pilot study is to evaluate whether HB05P, a health functional food ingredient containing pasteurized Akkermansia muciniphila HB05, improves muscle strength, and to evaluate its safety.
This is a randomized, double-blind, placebo-controlled, parallel-group, single-center study. A total of 80 adults aged 50 to under 80 years who meet the 2025 Asian Working Group for Sarcopenia (AWGS) criteria for sarcopenia or possible sarcopenia will be randomly assigned in a 1:1 ratio to the test group or the control group.
Participants will take one 430 mg hard capsule once daily with water after breakfast for 168 days (24 weeks). The test capsule contains 150 mg of HB05P (3 x 10^10 cells per day); the control capsule contains microcrystalline cellulose and is identical in appearance and packaging. All participants are asked to perform 30 to 60 minutes of walking and resistance exercise at least 3 times per week throughout the study and to keep an exercise diary and an intake diary.
The primary outcome is the change from baseline in peak torque per body weight (Nm/kg) of the quadriceps and hamstrings, measured with an isokinetic dynamometer at an angular velocity of 60 degrees per second and averaged across the left and right sides. Secondary outcomes include average power, muscle strength, muscle mass measured by dual-energy X-ray absorptiometry, handgrip strength, Short Physical Performance Battery scores, muscle-related blood markers, and quality of life. Efficacy and safety are assessed at baseline (Day 0), Week 12 (Day 84), and Week 24 (Day 168).
详细描述
Study design This is a randomized, double-blind, placebo (comparator food)-controlled, parallel-group, single-center exploratory (pilot) clinical trial of a health functional food ingredient. Eligible participants who provide written informed consent are randomly assigned 1:1 to the test group or the control group.
Sample size 64 participants (32 per group) are required for efficacy evaluation. Allowing for a 20 percent dropout rate, 80 participants (40 per group) will be enrolled.
Study population Adults aged 50 to under 80 years who meet the 2025 AWGS criteria for sarcopenia or possible sarcopenia. Muscle mass is assessed as ASM/height^2 by bioelectrical impedance analysis, handgrip strength as the maximum value of the dominant hand, and physical performance by the 5-time chair stand test of the Short Physical Performance Battery.
Investigational products Test food: one hard capsule of 430 mg containing 150 mg HB05P (pasteurized Akkermansia muciniphila HB05), microcrystalline cellulose, silicon dioxide, and magnesium stearate. Control food: one hard capsule of 430 mg containing microcrystalline cellulose, silicon dioxide, and magnesium stearate, without HB05P. Both capsules are manufactured to be indistinguishable in internal and external appearance and are supplied in identical packaging.
Dosing One capsule once daily with water after breakfast for 168 days (24 weeks). Study food is dispensed at Visit 2 and Visit 3, 92 capsules at each visit. Intake is recorded by the participant in an intake diary, and compliance is checked at Visit 3 and Visit 4.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men or women aged 50 to under 80 years
- •Meeting the 2025 Asian Working Group for Sarcopenia (AWGS) criteria for sarcopenia (low muscle mass and low handgrip strength) or possible sarcopenia (low muscle mass with either low handgrip strength or low physical performance). Low muscle mass is defined as ASM/height^2 measured by bioelectrical impedance analysis below 7.6 kg/m^2 for men and below 5.7 kg/m^2 for women aged 50 to 64 years, and below 7.0 kg/m^2 for men and below 5.7 kg/m^2 for women aged 65 years or older. Low handgrip strength is defined as the maximum value of the dominant hand at or below the following thresholds: 34.5 kg for men and 22.0 kg for women aged 50 to 54 years; 33.5 kg for men and 21.5 kg for women aged 55 to 59 years; 31.0 kg for men and 20.0 kg for women aged 60 to 64 years; 29.0 kg for men and 19.0 kg for women aged 65 to 69 years; 27.5 kg for men and 18.0 kg for women aged 70 to 74 years; 26.0 kg for men and 16.8 kg for women aged 75 to 79 years. Low physical performance is defined as more than 10 seconds on the 5-time chair stand test of the Short Physical Performance Battery for participants aged 50 to 64 years, and more than 12 seconds for those aged 65 years or older.
- •Not having participated in a commercial exercise program or performed regular resistance exercise 2 or more times per week within the 3 months before study participation
- •Physically able to participate in the standardized resistance exercise program provided from the start of the study at least 3 times per week, and willing to comply with it
- •Having received a full explanation of the purpose and procedures of the study and having voluntarily provided written informed consent
排除标准
- •Short Physical Performance Battery total score of 3 or less
- •Cachexia or unintentional weight loss of 5 percent or more within the past 3 months
- •History of fracture or musculoskeletal surgery within the past 6 months
- •Musculoskeletal or functional limitation that precludes isokinetic strength testing or performance of the standardized exercise program (for example, severe osteoarthritis or rheumatoid arthritis)
- •Uncontrolled or clinically unstable endocrine disease (for example, Cushing syndrome or adrenal insufficiency)
- •Severe respiratory disease (COPD GOLD stage III to IV or long-term oxygen therapy)
- •Uncontrolled hypertension (systolic blood pressure 160 mmHg or higher, or diastolic blood pressure 100 mmHg or higher), uncontrolled diabetes mellitus (fasting glucose 160 mg/dL or higher), or uncontrolled thyroid disease
- •Major cardiovascular or cerebrovascular event within the past 6 months (acute myocardial infarction, stroke, unstable angina, percutaneous coronary intervention, or coronary artery bypass grafting)
- •History of malignancy within 3 years before screening or currently receiving anticancer treatment, except malignancies with negligible risk of metastasis or death such as adequately treated non-melanoma skin cancer or carcinoma in situ
- •AST or ALT greater than 3 times the upper limit of normal at screening
- •Serum creatinine greater than 2 times the upper limit of normal at screening
- •History of gastrointestinal surgery or gastrointestinal disease that may affect absorption of the study food, except simple appendectomy or hernia repair
- •Known hypersensitivity to the active ingredient or any component of the study food
- •Use of systemic antibiotics or bowel preparation agents within 2 weeks before screening
- •Intake of probiotics, prebiotics, or lactic acid bacteria or fermented milk products 4 or more times per week within 2 weeks before screening, excluding fermented foods included in a regular diet
- •Continuous use of protein supplements or muscle-related health functional foods within 1 month before screening
- •Use of medications that may affect muscle mass or muscle strength within 3 months before screening, including systemic corticosteroids (oral or injectable), testosterone, growth hormone preparations, selective androgen receptor modulators, and anti-obesity drugs
- •Severe alcohol use disorder according to DSM-5 diagnostic criteria
- •Continuous use of psychiatric medication for schizophrenia, bipolar disorder, or severe major depressive disorder, excluding intermittent medication for sleep disturbance
- •Participation in another clinical trial within 3 months before screening, or current participation in another clinical trial
- •Women who are pregnant, breastfeeding, or planning to become pregnant during the study period
- •Any other condition that, in the judgment of the principal investigator, may affect the safety of the participant or the integrity of the study results
研究组 & 干预措施
Test group: HB05P
Participants receive one hard capsule of 430 mg containing 150 mg HB05P (pasteurized Akkermansia muciniphila HB05, 3 x 10^10 cells per day) once daily with water after breakfast for 168 days (24 weeks). In addition, participants perform walking and resistance exercise for 30 to 60 minutes at least 3 times per week throughout the study period.
干预措施: HB05P (Dietary Supplement)
Control group: Placebo
Participants receive one hard capsule of 430 mg without HB05P, once daily with water after breakfast for 168 days (24 weeks). The capsule is identical to the test capsule in internal and external appearance and packaging. In addition, participants perform walking and resistance exercise for 30 to 60 minutes at least 3 times per week throughout the study period.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Change from baseline in peak torque per body weight of the quadriceps and hamstrings (average of left and right)
时间窗: Baseline, Week 12 (Day 84), and Week 24 (Day 168)
Change from baseline in peak torque normalized to body weight (Nm/kg) of the quadriceps and hamstrings, measured with an isokinetic dynamometer at an angular velocity of 60 degrees per second. The value is the average of the left and right sides.
次要结局
- Change from baseline in peak torque per body weight of the quadriceps and hamstrings (right, left, dominant, non-dominant)(Baseline, Week 12 (Day 84), and Week 24 (Day 168))
- Change from baseline in average power of the quadriceps and hamstrings (right, left, dominant, non-dominant, average of left and right)(Baseline, Week 12 (Day 84), and Week 24 (Day 168))
- Change from baseline in muscle strength of the quadriceps and hamstrings (right, left, dominant, non-dominant, average of left and right)(Baseline, Week 12 (Day 84), and Week 24 (Day 168))
- Change from baseline in skeletal muscle mass by dual-energy X-ray absorptiometry (DXA)(Baseline, Week 12 (Day 84), and Week 24 (Day 168))
- Change from baseline in appendicular skeletal muscle mass (ASM)/height^2(Baseline, Week 12 (Day 84), and Week 24 (Day 168))
- Change from baseline in body fat percentage(Baseline, Week 12 (Day 84), and Week 24 (Day 168))
- Change from baseline in appendicular skeletal muscle mass (ASM)/weight x 100(Baseline, Week 12 (Day 84), and Week 24 (Day 168))
- Change from baseline in skeletal muscle mass/height^2(Baseline, Week 12 (Day 84), and Week 24 (Day 168))
- Change from baseline in lower-limb muscle mass(Baseline, Week 12 (Day 84), and Week 24 (Day 168))
- Change from baseline in Short Physical Performance Battery (SPPB) score(Baseline, Week 12 (Day 84), and Week 24 (Day 168))
- Change from baseline in quality of life assessed by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire(Baseline, Week 12 (Day 84), and Week 24 (Day 168))
- Change from baseline in serum albumin(Baseline, Week 12 (Day 84), and Week 24 (Day 168))
- Change from baseline in serum prealbumin(Baseline, Week 12 (Day 84), and Week 24 (Day 168))
- Change from baseline in handgrip strength (right, left, dominant, non-dominant, average of left and right)(Baseline, Week 12 (Day 84), and Week 24 (Day 168))
- Change from baseline in serum creatinine(Baseline, Week 12 (Day 84), and Week 24 (Day 168))
- Change from baseline in serum total protein(Baseline, Week 12 (Day 84), and Week 24 (Day 168))
- Change from baseline in serum C-reactive protein(Baseline, Week 12 (Day 84), and Week 24 (Day 168))
- Change from baseline in serum creatine kinase(Baseline, Week 12 (Day 84), and Week 24 (Day 168))
- Change from baseline in serum insulin-like growth factor 1 (IGF-1)(Baseline, Week 12 (Day 84), and Week 24 (Day 168))
- Change from baseline in serum follistatin(Baseline, Week 12 (Day 84), and Week 24 (Day 168))
- Change from baseline in serum myostatin(Baseline, Week 12 (Day 84), and Week 24 (Day 168))
- Change from baseline in absolute skeletal muscle mass measured by dual-energy X-ray absorptiometry (DXA)(Baseline, Week 12 (Day 84), and Week 24 (Day 168))
- Incidence of treatment-emergent adverse events(Day 0 to Week 24 (Day 168))
研究者
Sang Yeoup Lee
Professor
Pusan National University Yangsan Hospital