Evaluation of the JUICE HA® as an Anti-sarcopenia

NCT06950125 | Recruiting

• 1 other identifier: CMUH114-REC3-004
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia in Elderly

Keywords

sarcopenia; quality of life

Outcome Measures

Primary Outcomes (10)

• Grip Strength

  Participants will be instructed to stand naturally with both arms relaxed at their sides. The examiner will adjust the grip span of the dynamometer, ensuring that when holding the handle, the second joint of the index finger forms approximately a 90-degree angle. Handgrip strength will be measured for both the dominant and non-dominant hands. After completing the measurement for one hand, the dynamometer will be reset to zero, and the participant will rest for 30 seconds before testing the other hand. Each hand will be tested twice, and the highest value recorded (in kilograms) will be used for analysis. Standard for male participants: \< 28 kg; for female participants: \< 18 kg.

  From enrollment to the end of treatment at 24 weeks

• Chair Stand Test

  Prior to data collection, participants will perform three practice trials to familiarize themselves with the test procedure. At the start of the test, participants will be seated on a chair with a neutral spine posture and both feet flat on the floor. Participants will be instructed to rise from the chair and return to a seated position as quickly as possible. The verbal cue "1, 2, 3, GO" will be given, and the stopwatch will be started simultaneously with the "GO" command. Participants will be instructed to complete five full sit-to-stand cycles as quickly as possible without using their arms for assistance. A total time exceeding 15 seconds is considered indicative of low muscle strength.

  From enrollment to the end of treatment at 24 weeks

• Appendicular Skeletal Muscle Mass (ASM)

  Appendicular skeletal muscle mass (ASM) will be measured using a Dual-Energy X-ray Absorptiometry (DXA) scanner. The skeletal muscle mass of the four limbs will be assessed to determine the participants' muscle status. A cut-off value of 20 kilograms for males and 15 kilograms for females will be used to define low muscle mass, with values below these thresholds indicating reduced skeletal muscle mass.

  From enrollment to the end of treatment at 24 weeks

• Appendicular Skeletal Muscle Mass Index

  The appendicular skeletal muscle mass (ASM) obtained from the DXA measurement will be divided by the square of the participant's height to calculate the appendicular skeletal muscle mass index (ASMI). A cut-off value of 7.0 kg/m² for males and 5.5 kg/m² for females will be used to define low muscle mass index, with values below these thresholds indicating low skeletal muscle mass relative to body size.

  From enrollment to the end of treatment at 24 weeks

• Gait Speed

  A 6-meter gait speed test will be conducted to assess walking speed. Participants will be instructed to walk at their usual pace over a distance of 6 meters, and the time taken to complete the distance will be recorded. Gait speed will be calculated by dividing the distance by the time, and a gait speed of less than 1.0 meter per second will be considered indicative of low physical performance.

  From enrollment to the end of treatment at 24 weeks

• Short Physical Performance Battery (SPPB)

  Researchers received training in the administration of the Short Physical Performance Battery (SPPB) and were audited by the same trainer to ensure accurate and standardized execution. The SPPB, with a total score of 12 points, comprises three components: a standing balance test, a gait speed test, and a chair stand test. Based on the total score, participants are classified as frail (4-7 points), pre-frail (8-9 points), or functionally normal (10-12 points). Before testing, researchers explained the procedures and purpose of the assessments to the participants and demonstrated the key points of each movement. Participants were allowed one practice trial before formal testing. A 3-minute rest period was provided between the practice and formal test for each component.

  From enrollment to the end of treatment at 24 weeks

• Sarcopenia Quality of Life (SarQoL)

  The Sarcopenia and Quality of Life (SarQoL) questionnaire will be used to assess the quality of life in individuals with sarcopenia. The questionnaire can be either self-administered by the participants or administered with the assistance of researchers through verbal questioning. The SarQoL consists of 55 items grouped into 22 questions and is designed to be completed within approximately 10 minutes.

  From enrollment to the end of treatment at 24 weeks

• Clinical Biochemistry of total antioxidant capacity and lipid peroxidation

  Blood samples were collected at five different time points (week 0, week 6, week 12, week 18, week 24). The scavenging ability of antioxidants (6-hydroxy-2,5,7,8-tetramethylchroman-2-carboxylic acid, Trolox) was determined using a curve, and the amount of Trolox equivalent to the test serum's inhibition rate was calculated. Next, the level of malondialdehyde (MDA), a standard biomarker of lipid peroxidation, was determined by an ELISA kit provided by the Caman Company (Cayman Chemical Company, Michigan, USA). As described in the protocol, the reaction mixture was boiled at 90-100°C for 60 min, and the absorbance at 550 nm was measured using an ELISA plate reader (Tecan GENios, A-5082, Austria). The values are expressed as micromoles of MDA per liter.

  From enrollment to the end of treatment at 24 weeks

• Clinical Biochemistry of the inflammatory response

  Blood samples were collected at five different time points (week 0, week 6, week 12, week 18, week 24). The concentrations of serum cytokines IL-6, IL-10, TNF-α, and high-sensitivity C-reactive protein (hs-CRP) will be measured using commercially available assay kits (Bio-Legend Inc., No. 430207, San Diego, CA) and enzyme-linked immunosorbent assay (ELISA) methods (Tecan GENios, A-5082, Austria). Absorbance readings will be taken at wavelengths of 450 nm, 545 nm, 520 nm, and 570 nm, respectively. The concentrations of IL-6, IL-10, TNF-α, and hs-CRP in serum samples will be calculated based on the corresponding standard curves.

  From enrollment to the end of treatment at 24 weeks

• Clinical Biochemistry of biomarkers of muscle synthesis and degradation

  Blood samples were collected at five different time points (week 0, week 6, week 12, week 18, week 24). Then will be assessed by measuring serum levels of mTOR and RSK (muscle synthesis markers) and MuRF1 and atrogin-1 (muscle degradation markers). These biomarkers will be quantified using commercially available assay kits and enzyme-linked immunosorbent assay (ELISA) methods (Tecan GENios, A-5082, Austria). Absorbance readings will be taken at wavelengths of 450 nm and 570 nm, respectively. The concentrations of mTOR, RSK, MuRF1, and atrogin-1 in serum samples will be determined based on the corresponding standard curves.

  From enrollment to the end of treatment at 24 weeks

Study Arms (2)

JUICE HA® supplement

EXPERIMENTAL

Bottle with 15 ml of JUICE HA® supplement

Other: JUICE HA® supplement

Placebo

PLACEBO COMPARATOR

Bottle of 15 mL liquid (non-effective product).

Other: Placebo

Interventions

Placebo OTHER

Bottle of 15 mL liquid (non-effective product) will be taken once a day for 12 weeks.

Placebo

JUICE HA® supplement OTHER

Bottle of 15 mL JUICE HA® supplement will be taken once a day for 12 weeks.

JUICE HA® supplement

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, 404327, Taiwan

RECRUITING

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Central Study Contacts

Chih-Hsueh Lin, Medical Master Degree

CONTACT

+886422053366; d5496lin@mail.cmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: April 30, 2025
• Study Start: June 23, 2025
• Primary Completion: December 31, 2025
• Study Completion: March 13, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)