HB05P on Muscle Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-79
SponsorPusan National University Yangsan Hospital
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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/height² measured by bioelectrical impedance analysis below 7.6 kg/m² for men and below 5.7 kg/m² for women aged 50 to 64 years, and below 7.0 kg/m² for men and below 5.7 kg/m² 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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
HB05P
Dietary supplementHard capsule of 430 mg containing 150 mg HB05P (pasteurized Akkermansia muciniphila HB05), microcrystalline cellulose, silicon dioxide, and magnesium stearate. One capsule once daily with water after breakfast for 168 days, providing 3 x 10\^10 cells per day. Study food is dispensed at Visit 2 and Visit 3, 92 capsules at each visit.
Placebo
Dietary supplementHard capsule of 430 mg containing microcrystalline cellulose, silicon dioxide, and magnesium stearate, without HB05P. One capsule once daily with water after breakfast for 168 days. Study food is dispensed at Visit 2 and Visit 3, 92 capsules at each visit.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Test group: HB05PExperimental treatment 1 intervention
Group B: Control group: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline in peak torque per body weight of the quadriceps and hamstrings (average of left and right)
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.
Time frame
Baseline, Week 12 (Day 84), and Week 24 (Day 168)Secondary outcomes
1
Change from baseline in peak torque per body weight of the quadriceps and hamstrings (right, left, dominant, non-dominant)
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. Values are reported for the right side, the left side, the dominant side, and the non-dominant side. The dominant side is defined as the participant's dominant leg as recorded at screening.
Time frame
Baseline, Week 12 (Day 84), and Week 24 (Day 168)2
Change from baseline in average power of the quadriceps and hamstrings (right, left, dominant, non-dominant, average of left and right)
Change from baseline in average power (Watts) of the quadriceps and hamstrings, measured with an isokinetic dynamometer at an angular velocity of 60 degrees per second. Values are reported for the right side, the left side, the dominant side, the non-dominant side, and the average of the left and right sides.
Time frame
Baseline, Week 12 (Day 84), and Week 24 (Day 168)3
Change from baseline in muscle strength of the quadriceps and hamstrings (right, left, dominant, non-dominant, average of left and right)
Change from baseline in muscle strength (Nm) of the quadriceps and hamstrings, measured with an isokinetic dynamometer at an angular velocity of 60 degrees per second. Values are reported for the right side, the left side, the dominant side, the non-dominant side, and the average of the left and right sides.
Time frame
Baseline, Week 12 (Day 84), and Week 24 (Day 168)4
Change from baseline in absolute skeletal muscle mass measured by dual-energy X-ray absorptiometry (DXA)
Change from baseline in absolute skeletal muscle mass (kg) measured by dual-energy X-ray absorptiometry.
Time frame
Baseline, Week 12 (Day 84), and Week 24 (Day 168)Sponsors and contacts
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Source ClinicalTrials.gov