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A 12-week, single-center, randomized, double-blind, placebo-controlled clinical trial to evaluate efficacy and safety for improvement of HFN2-017 on muscle strength

A 12-week, single-center, randomized, double-blind, placebo-controlled clinical trial to evaluate efficacy and safety for improvement of HFN2-017 on muscle strength

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0011350
Enrollment
100
Registered
2025-12-18
Start date
2025-10-17
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Others : The subjects were randomly assigned to one of the two groups, and for 12 weeks, they were given test and control foods Eat three capsules once a day, once a day, depending on the intake metho

Sponsors

Huons
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) The standard measurement of grip strength among adult men and women aged 50 to 85 at the time of screening Those who fall under the following* (However, according to the 2019 Asian Sarcopenia Guidelines, 28kg of grip strength, Except for women who weigh less than 18 kg)* 2022 National Health Statistics Standards 2) Those with skeletal muscle mass (SMM) less than 110% of the standard range 3) voluntarily agree to participate in this human body application test, understand the test method and process a person capable of compliance

Exclusion criteria

Exclusion criteria: 1) Those with a total score of 4 or more in the Sarcopenia Self-Diagnosis Questionnaire (SARC-F) 2) A person with a simple physical function test result of not more than 9 points 3) A person who falls under any of the following conditions ? Patients diagnosed with sarcopenia or with vulnerable hip fractures ? Patients with musculoskeletal abnormalities or damage in the lower extremities that affect walking (such as those requiring treatment) Matisse arthritis, claudication spinal stenosis, severe osteoarthritis, spinal injury, etc.) ? A person who is taking medication for depression or psychiatric disorders (however, intermittent due to sleep disorders) If administered, registration is possible) ? A person who has a history of cancer within five years or is currently being treated ...? Individuals who are unable to communicate or walk due to dementia or Parkinson's disease (mild symptoms may participate) ? Individuals with suspected or known alcohol addiction or drug abuse ? Individuals who have experienced a myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention (e.g., angioplasty or stent insertion), unstable angina classified as New York Heart Association Class III and IV heart failure, severe heart valve disease or defects (e.g., aortic or mitral stenosis), stroke, or untreated atrial fibrillation within the past 3 months ? Uncontrolled diabetic patients (HbA1C > 7.0 %) ? Uncontrolled hypertension (SBP > 160 mmHg or DBP > 100 mmHg) ? History of lung disease or systemic autoimmune disease 4) Taking the following medications/health functional foods/foods as of the screening visit: ? Taking medications related to muscle strength improvement within the past 3 months ? Taking health functional foods or foods related to muscle strength improvement (protein supplements containing amino acids, creatine, etc., muscle strength supplements, hormone supplements, vitamin D, etc.) within the past 3 months (However, vitamin D can be taken if the dosage has not changed for the past 3 months) ? Taking oral steroids or hormones (testosterone, estrogen, androgens, growth hormones, adrenal cortex hormones, etc.) within the past 4 weeks 5) Participating in aerobic or resistance exercise (strength training) consistently within the past 3 months as of the screening visit 6) Pregnant or lactating women or those planning to become pregnant. 7) Alcohol consumption [Men = 40 g/day, Women = 20 g/day (based on WHO daily alcohol intake guidelines)] 8) Heavy smokers (= 20 cigarettes/day) 9) Participants in other human clinical trials within the past 3 months prior to the screening date. 10) Participants with allergies/adverse reactions to test substances. 11) Participants who have participated or plan to participate in other human clinical trials or clinical studies within the past 3 months. 12) Participants with the following results in diagnostic laboratory tests: - eGFR 3 times the upper limit of normal - Creatinine > 2.0 mg/dL - Thyroid-stimulating hormone (TSH) levels 10 µIU/mL. 13) Results of diagnostic laboratory tests and Those deemed unsuitable for research participation by the principal investigator for other reasons

Design outcomes

Primary

MeasureTime frame
Strength of quadriceps femoris muscle

Secondary

MeasureTime frame
Grip strength; muscle mass;Short Physical performance battery; blood index; muscle metabolism and damage index;subjective questionnaire evaluation

Countries

Korea, Republic of

Contacts

Public ContactMoon Chul Lee

Bestian Seoul Hospital

mcbestian@bestian.kr+82-2-6211-7977

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026