Clinical trial NCT06950125: Evaluation of the JUICE HA® as an Anti-sarcopenia
Official title: Evaluation of the JUICE HA® as an Anti-sarcopenia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sarcopenia in Elderly
Keywords: sarcopenia
quality of life
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2025-04-30
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 60 participants aged 65 and above who have been diagnosed with sarcopenia will be randomly assigned into two groups using an envelope-drawing method: one group will receive the JUICE HA® supplement, while the other group will receive a placebo. The supplementation period will last for 12 weeks. Comparisons between the two groups will be conducted at baseline (pre-test) and after the intervention (post-test).
Primary purpose: OTHER

Brief summary: This study plans to recruit 60 participants aged 65 years and older who have been diagnosed with sarcopenia by a physician. Participants will be randomly assigned into JUICE HA® supplement and placebo group. All of the participants will be asked to take 15 mL/day of JUICE HA® supplement or placebo group for 12 weeks. The aim of this trial is to evaluate the potential of JUICE HA® to enhance physiological status (muscle mass and functional fitness) and to improve the quality of life in patients with sarcopenia.

Detailed description: JUICE HA® is a nutritional supplement formulated with hyaluronic acid (HA), branched-chain amino acids (BCAA), and chondroitin. Hyaluronic acid contributes to enhancing hydration levels in the skin and connective tissues; BCAA promotes muscle protein synthesis and repair; and chondroitin is believed to support the structural integrity and functionality of joints. The synergistic combination of these components is anticipated to provide comprehensive, multidimensional support for individuals with sarcopenia, potentially alleviating symptoms and improving overall quality of life. Therefore, this study will explore 15 mL/day of JUICE HA® supplement to improve the muscle mass and functional fitness in the elderly with sarcopenia.

This study aims to recruit 60 participants aged 65 years and older who have been diagnosed with sarcopenia by a physician and meet the Asian Working Group for Sarcopenia (AWGS) 2019 diagnostic criteria. Participants will be enrolled in a randomized control-group pretest-posttest design and randomly assigned to receive either the JUICE HA® supplement or a placebo (Lin et al., 2021). Functional fitness assessments, the Sarcopenia Quality of Life questionnaire (SarQoL), and blood sample collections will be conducted at baseline, at the 6th and 12th weeks of the supplementation period, and at the 6th and 12th weeks of the follow-up period. Blood samples will be analyzed for oxidative stress markers (SOD, MDA), inflammatory markers (TNF-α, IL-10), and muscle synthesis and degradation indicators (mTOR, MuRF1, atrogin-1). Body composition assessments will be performed at baseline, at the 12th week of the supplementation period, and at the 12th week of the follow-up period.

Eligibility criteria: Inclusion Criteria:

* Participants that have been diagnosed with sarcopenia by a physician and meet the AWGS 2019 criteria for sarcopenia.

Exclusion Criteria:

* Participants with a history of severe lower extremity musculoskeletal injuries within the past six months or those who have a fear of blood sampling will be excluded.

Primary outcomes:
measure: Grip Strength
timeFrame: From enrollment to the end of treatment at 24 weeks
measure: Chair Stand Test
timeFrame: From enrollment to the end of treatment at 24 weeks
measure: Appendicular Skeletal Muscle Mass (ASM)
timeFrame: From enrollment to the end of treatment at 24 weeks
measure: Appendicular Skeletal Muscle Mass Index
timeFrame: From enrollment to the end of treatment at 24 weeks
measure: Gait Speed
timeFrame: From enrollment to the end of treatment at 24 weeks
measure: Short Physical Performance Battery (SPPB)
timeFrame: From enrollment to the end of treatment at 24 weeks
measure: Sarcopenia Quality of Life (SarQoL)
timeFrame: From enrollment to the end of treatment at 24 weeks
measure: Clinical Biochemistry of total antioxidant capacity and lipid peroxidation
timeFrame: From enrollment to the end of treatment at 24 weeks
measure: Clinical Biochemistry of the inflammatory response
timeFrame: From enrollment to the end of treatment at 24 weeks
measure: Clinical Biochemistry of biomarkers of muscle synthesis and degradation
timeFrame: From enrollment to the end of treatment at 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
References: