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Recruiting NCT06950125

Evaluation of the JUICE HA® as an Anti-sarcopenia

No phase Interventional Sarcopenia in Elderly

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Placebo, JUICE HA® supplement.
Who it may be relevant to
Registry conditions: Sarcopenia in Elderly. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other Placebo
    Bottle of 15 mL liquid (non-effective product) will be taken once a day for 12 weeks.
  • Other JUICE HA® supplement
    Bottle of 15 mL JUICE HA® supplement will be taken once a day for 12 weeks.

Primary outcome measures

  • Grip Strength [Time frame: From enrollment to the end of treatment at 24 weeks]
  • Chair Stand Test [Time frame: From enrollment to the end of treatment at 24 weeks]
  • Appendicular Skeletal Muscle Mass (ASM) [Time frame: From enrollment to the end of treatment at 24 weeks]
  • Appendicular Skeletal Muscle Mass Index [Time frame: From enrollment to the end of treatment at 24 weeks]
  • Gait Speed [Time frame: From enrollment to the end of treatment at 24 weeks]
  • Short Physical Performance Battery (SPPB) [Time frame: From enrollment to the end of treatment at 24 weeks]
  • Sarcopenia Quality of Life (SarQoL) [Time frame: From enrollment to the end of treatment at 24 weeks]
  • Clinical Biochemistry of total antioxidant capacity and lipid peroxidation [Time frame: From enrollment to the end of treatment at 24 weeks]
  • Clinical Biochemistry of the inflammatory response [Time frame: From enrollment to the end of treatment at 24 weeks]
  • Clinical Biochemistry of biomarkers of muscle synthesis and degradation [Time frame: From enrollment to the end of treatment at 24 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Other

Study locations

Taiwan · 1 center
  • China Medical University Hospital — Taichung

Identifiers

NCT: NCT06950125 · CMUH114-REC3-004

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗