An interventional study of HB05P and Placebo in Sarcopenia and Possible Sarcopenia, sponsored by Pusan National University Yangsan Hospital. Recruiting at 1 site in South Korea. Open to participants aged 50 Years to 79 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by Pusan National University Yangsan Hospital · Not applicable, Interventional, and Prevention
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).
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.
1,329 studies on the registry are indexed under Sarcopenia; 420 are open to participants now.
This study's planned enrollment of 80 is above the median of 60 across 855 interventional studies indexed under Sarcopenia.
Browse Sarcopenia studies →Pusan National University Yangsan Hospital is the lead sponsor of 108 studies on the registry; 27 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Dietary Supplement: HB05P
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.
Dietary Supplement: Placebo
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.
Also known as: Pasteurized Akkermansia muciniphila HB05
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.
Also known as: Comparator food
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)
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)
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)
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)
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)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: Day 0 to Week 24 (Day 168)
Plan to share: 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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