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 muscle power, 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 Day 0, Day 84, and Day 168.
Inclusion Criteria:
Exclusion Criteria:
drsaylee@gmail.com
Participants receive one hard capsule of 430 mg containing 150 mg HB05P (pasteurized Akkermansia muciniphila HB05, 3 x 10\^10 cells) 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.
Participants receive one hard capsule of 430 mg containing microcrystalline cellulose 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.
Postacute Sarcopenia: Supplementation With β-hydroxyMethylbutyrate After Resistance Training
Nutritional Intervention for Age-related Muscular Function and Strength Losses-Study 2
Protein Supplementation Intervention for Improving Muscle Mass and Physical Performance in Older People With Sarcopenia
Effect of Lactiplantibacillus Plantarum LM1001 on Muscle Strength in Older Adults