SarcopeniaNCT07749118
HB05P on Muscle Health
A study testing HB05P in people with Sarcopenia and Possible Sarcopenia, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Possible Sarcopenia
- What is being tested?
- HB05P
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Sep 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 22Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Pusan National University Yangsan Hospital
Yangsan, 50612
Professor, +82-55-360-2860, drsaylee@gmail.com
About this study
Official title: The Effect of HB05P Supplementation on Muscle Strength Improvement: A Randomized, Double-blind, Controlled Preliminary Clinical Trial (HB05P-Muscle 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.
Read more
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).
Read the detailed description
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.
Blinding Randomization code assignment is kept sealed by the principal investigator and is not disclosed until the end of the study. If emergency unblinding is required for a serious adverse reaction, only the assignment of the individual participant can be opened, using participant-specific sealed envelopes. The randomization code is opened for efficacy analysis after study completion.
Visit schedule Visit 1, screening, Day -14 to Day -1: informed consent, eligibility assessment, demographics, medical and medication history, physical examination, eligibility tests, vital signs, clinical laboratory tests.
Visit 2, baseline, Day 0: eligibility assessment, physical examination, clinical laboratory tests, efficacy assessments, questionnaires, concomitant medication check, dispensing of study food.
Visit 3, Day 84 plus or minus 8 days: physical examination, vital signs, clinical laboratory tests, efficacy assessments, questionnaires, adverse event check, concomitant medication check, compliance check, dispensing of study food.
Visit 4, Day 168 plus or minus 8 days: physical examination, vital signs, clinical laboratory tests, efficacy assessments, questionnaires, adverse event check, concomitant medication check, compliance check.
Efficacy assessments (Visit 2, Visit 3, Visit 4) Isokinetic dynamometry at 60 degrees per second: peak torque per body weight of the quadriceps and hamstrings (right, left, dominant, non-dominant, and the average of left and right), average power (right, left, dominant, non-dominant, and the average of left and right), and muscle strength (right, left, dominant, non-dominant, and the average of left and right). Dual-energy X-ray absorptiometry: absolute skeletal muscle mass, ASM/height^2, ASM/weight x 100, skeletal muscle mass/height^2, lower-limb muscle mass, and body fat percentage (total, trunk). Handgrip strength (right, left, dominant, non-dominant, and the average of left and right). Short Physical Performance Battery total score and subscores. Blood markers: creatinine, total protein, albumin, prealbumin, C-reactive protein, creatine kinase, insulin-like growth factor 1, follistatin, and myostatin. Quality of life by EQ-5D-5L, a 24-hour dietary recall, and an exercise diary.
Safety assessments Adverse events, vital signs, physical examination, and clinical laboratory tests are collected at the scheduled visits and evaluated for severity and causal relationship to the study food.
Concomitant exercise All participants perform walking and resistance exercise for 30 to 60 minutes at least 3 times per week until the end of the study and record it in an exercise diary.
- Conditions
- Sarcopenia, Possible Sarcopenia
- Being tested
- HB05P, Placebo
- Keywords
- Akkermansia muciniphila, Postbiotic, Muscle strength, Skeletal muscle mass, Functional food
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HB05PDietary supplement
Also called Pasteurized Akkermansia muciniphila HB05
Hard 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.
PlaceboDietary supplement
Also called Comparator food
Hard 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.
| Study group | Role | What they receive |
|---|---|---|
| Test group: HB05P | Experimental | 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. Receives: Dietary Supplement: HB05P |
| Control group: Placebo | Placebo comparator | 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 12 (Day 84), and Week 24 (Day 168)
Secondary outcomes (22)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
Change from baseline in absolute skeletal muscle mass (kg) measured by dual-energy X-ray absorptiometry.
Measured: Baseline, Week 12 (Day 84), and Week 24 (Day 168)
Change from baseline in appendicular skeletal muscle mass (ASM)/height^2
Change from baseline in appendicular skeletal muscle mass divided by height squared (kg/m^2), measured by dual-energy X-ray absorptiometry.
Measured: Baseline, Week 12 (Day 84), and Week 24 (Day 168)
Change from baseline in body fat percentage
Change from baseline in body fat percentage (total and trunk) measured by dual-energy X-ray absorptiometry.
Measured: Baseline, Week 12 (Day 84), and Week 24 (Day 168)
Change from baseline in appendicular skeletal muscle mass (ASM)/weight x 100
Change from baseline in appendicular skeletal muscle mass divided by body weight, multiplied by 100 (percent), measured by dual-energy X-ray absorptiometry.
Measured: Baseline, Week 12 (Day 84), and Week 24 (Day 168)
Change from baseline in skeletal muscle mass/height^2
Change from baseline in skeletal muscle mass divided by height squared (kg/m^2), measured by dual-energy X-ray absorptiometry.
Measured: Baseline, Week 12 (Day 84), and Week 24 (Day 168)
Change from baseline in lower-limb muscle mass
Change from baseline in lower-limb muscle mass (kg) measured by dual-energy X-ray absorptiometry.
Measured: 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)
Change from baseline in handgrip strength (kg) measured with a hand dynamometer. Values are reported for the right hand, the left hand, the dominant hand, the non-dominant hand, and the average of the left and right hands. The dominant hand is defined as the hand the participant habitually uses, as recorded at screening.
Measured: Baseline, Week 12 (Day 84), and Week 24 (Day 168)
Change from baseline in Short Physical Performance Battery (SPPB) score
Change from baseline in the Short Physical Performance Battery total score and its subscores. The total score ranges from 0 to 12, with higher scores indicating better physical performance.
Measured: Baseline, Week 12 (Day 84), and Week 24 (Day 168)
Change from baseline in serum creatinine
Change from baseline in serum creatinine (mg/dL). Blood samples are collected after an overnight fast of at least 8 hours.
Measured: Baseline, Week 12 (Day 84), and Week 24 (Day 168)
Change from baseline in serum total protein
Change from baseline in serum total protein (g/dL). Blood samples are collected after an overnight fast of at least 8 hours.
Measured: Baseline, Week 12 (Day 84), and Week 24 (Day 168)
Change from baseline in serum albumin
Change from baseline in serum albumin (g/dL). Blood samples are collected after an overnight fast of at least 8 hours.
Measured: Baseline, Week 12 (Day 84), and Week 24 (Day 168)
Change from baseline in serum prealbumin
Change from baseline in serum prealbumin (mg/dL). Blood samples are collected after an overnight fast of at least 8 hours.
Measured: Baseline, Week 12 (Day 84), and Week 24 (Day 168)
Change from baseline in serum C-reactive protein
Change from baseline in serum C-reactive protein (mg/L). Blood samples are collected after an overnight fast of at least 8 hours.
Measured: Baseline, Week 12 (Day 84), and Week 24 (Day 168)
Change from baseline in serum creatine kinase
Change from baseline in serum creatine kinase (IU/L). Blood samples are collected after an overnight fast of at least 8 hours.
Measured: Baseline, Week 12 (Day 84), and Week 24 (Day 168)
Change from baseline in serum insulin-like growth factor 1 (IGF-1)
Change from baseline in serum IGF-1 (ng/mL). Blood samples are collected after an overnight fast of at least 8 hours.
Measured: Baseline, Week 12 (Day 84), and Week 24 (Day 168)
Change from baseline in serum follistatin
Change from baseline in serum follistatin (ng/mL). Blood samples are collected after an overnight fast of at least 8 hours.
Measured: Baseline, Week 12 (Day 84), and Week 24 (Day 168)
Change from baseline in serum myostatin
Change from baseline in serum myostatin (ng/mL). Blood samples are collected after an overnight fast of at least 8 hours.
Measured: 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
Change from baseline in health-related quality of life assessed by the EQ-5D-5L questionnaire, reported as the index value and the EQ VAS score. Higher scores indicate better health status.
Measured: Baseline, Week 12 (Day 84), and Week 24 (Day 168)
Incidence of treatment-emergent adverse events
Number and proportion of participants with at least one treatment-emergent adverse event, summarized by severity and by causal relationship to the study food. Adverse events are collected from the first intake of study food until the final visit. Events occurring before the first intake are recorded as medical history.
Measured: Day 0 to Week 24 (Day 168)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion29 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang Yeoup Lee, Pusan National University Yangsan Hospital
- Investigators
- Sang Yeoup Lee, MD, PhD, Principal investigator, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07749118
- Sponsor's protocol ID
- 12-2026-011
- Status last verified
- Aug 2026
- First submitted
- 1 Aug 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. Data collected in this study are managed by the sponsor and are subject to confidentiality provisions of the study protocol and the informed consent obtained from participants. Summary results will be posted on ClinicalTrials.gov and reported in the clinical study report.
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of HB05P Supplementation on Muscle Strength Improvement: A Randomized, Double-blind, Controlled Preliminary Clinical Trial (HB05P-Muscle Trial)
- ClinicalTrials.gov ID
- NCT07749118
- Acronym / sponsor ID
- 12-2026-011
- Conditions
- Sarcopenia, Possible Sarcopenia
- Keywords
- Akkermansia muciniphila, Postbiotic, Muscle strength, Skeletal muscle mass, Functional food
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 29 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 6 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Blinding Randomization code assignment is kept sealed by the principal investigator and is not disclosed until the end of the study. If emergency unblinding is required for a serious adverse reaction, only the assignment of the individual participant can be opened, using participant-specific sealed envelopes. The randomization code is opened for efficacy analysis after study completion.
Visit schedule Visit 1, screening, Day -14 to Day -1: informed consent, eligibility assessment, demographics, medical and medication history, physical examination, eligibility tests, vital signs, clinical laboratory tests.
Visit 2, baseline, Day 0: eligibility assessment, physical examination, clinical laboratory tests, efficacy assessments, questionnaires, concomitant medication check, dispensing of study food.
Visit 3, Day 84 plus or minus 8 days: physical examination, vital signs, clinical laboratory tests, efficacy assessments, questionnaires, adverse event check, concomitant medication check, compliance check, dispensing of study food.
Visit 4, Day 168 plus or minus 8 days: physical examination, vital signs, clinical laboratory tests, efficacy assessments, questionnaires, adverse event check, concomitant medication check, compliance check.
Efficacy assessments (Visit 2, Visit 3, Visit 4) Isokinetic dynamometry at 60 degrees per second: peak torque per body weight of the quadriceps and hamstrings (right, left, dominant, non-dominant, and the average of left and right), average power (right, left, dominant, non-dominant, and the average of left and right), and muscle strength (right, left, dominant, non-dominant, and the average of left and right). Dual-energy X-ray absorptiometry: absolute skeletal muscle mass, ASM/height^2, ASM/weight x 100, skeletal muscle mass/height^2, lower-limb muscle mass, and body fat percentage (total, trunk). Handgrip strength (right, left, dominant, non-dominant, and the average of left and right). Short Physical Performance Battery total score and subscores. Blood markers: creatinine, total protein, albumin, prealbumin, C-reactive protein, creatine kinase, insulin-like growth factor 1, follistatin, and myostatin. Quality of life by EQ-5D-5L, a 24-hour dietary recall, and an exercise diary.
Safety assessments Adverse events, vital signs, physical examination, and clinical laboratory tests are collected at the scheduled visits and evaluated for severity and causal relationship to the study food.
Concomitant exercise All participants perform walking and resistance exercise for 30 to 60 minutes at least 3 times per week until the end of the study and record it in an exercise diary.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group: HB05P | Experimental | Dietary Supplement: HB05PParticipants 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. |
| Control group: Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants 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. |
Who may qualify
- Ages
- 50 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (22 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HB05PAlso: Pasteurized Akkermansia muciniphila HB05Hard 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. | Dietary supplement | Test group: HB05P |
| PlaceboAlso: Comparator foodHard 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. | Dietary supplement | Control group: Placebo |
Primary outcome
Change from baseline in peak torque per body weight of the quadriceps and hamstrings (average of left and right)
Time frame: 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.
22 secondary outcomes
Change from baseline in peak torque per body weight of the quadriceps and hamstrings (right, left, dominant, non-dominant)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Baseline, Week 12 (Day 84), and Week 24 (Day 168)
Change from baseline in appendicular skeletal muscle mass (ASM)/height^2
Time frame: Baseline, Week 12 (Day 84), and Week 24 (Day 168)
Change from baseline in body fat percentage
Time frame: Baseline, Week 12 (Day 84), and Week 24 (Day 168)
Change from baseline in appendicular skeletal muscle mass (ASM)/weight x 100
Time frame: Baseline, Week 12 (Day 84), and Week 24 (Day 168)
Change from baseline in skeletal muscle mass/height^2
Time frame: Baseline, Week 12 (Day 84), and Week 24 (Day 168)
Change from baseline in lower-limb muscle mass
Time frame: 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)
Time frame: Baseline, Week 12 (Day 84), and Week 24 (Day 168)
Change from baseline in Short Physical Performance Battery (SPPB) score
Time frame: Baseline, Week 12 (Day 84), and Week 24 (Day 168)
Change from baseline in serum creatinine
Time frame: Baseline, Week 12 (Day 84), and Week 24 (Day 168)
Change from baseline in serum total protein
Time frame: Baseline, Week 12 (Day 84), and Week 24 (Day 168)
Change from baseline in serum albumin
Time frame: Baseline, Week 12 (Day 84), and Week 24 (Day 168)
Change from baseline in serum prealbumin
Time frame: Baseline, Week 12 (Day 84), and Week 24 (Day 168)
Change from baseline in serum C-reactive protein
Time frame: Baseline, Week 12 (Day 84), and Week 24 (Day 168)
Change from baseline in serum creatine kinase
Time frame: Baseline, Week 12 (Day 84), and Week 24 (Day 168)
Change from baseline in serum insulin-like growth factor 1 (IGF-1)
Time frame: Baseline, Week 12 (Day 84), and Week 24 (Day 168)
Change from baseline in serum follistatin
Time frame: Baseline, Week 12 (Day 84), and Week 24 (Day 168)
Change from baseline in serum myostatin
Time frame: 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
Time frame: Baseline, Week 12 (Day 84), and Week 24 (Day 168)
Incidence of treatment-emergent adverse events
Time frame: Day 0 to Week 24 (Day 168)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. Data collected in this study are managed by the sponsor and are subject to confidentiality provisions of the study protocol and the informed consent obtained from participants. Summary results will be posted on ClinicalTrials.gov and reported in the clinical study report.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sang Yeoup Lee, MD, PhD principal investigator
Pusan National University Yangsan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HB05P in people with Sarcopenia and Possible Sarcopenia, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Professor (+82-55-360-2860, drsaylee@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in peak torque per body weight of the quadriceps and hamstrings (average of left and right) (time frame: Baseline, Week 12 (Day 84), and Week 24 (Day 168)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.