Evaluation of the JUICE HA® as an Anti-sarcopenia
ConditionSarcopenia in Elderly
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorChina Medical University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants that have been diagnosed with sarcopenia by a physician and meet the AWGS 2019 criteria for sarcopenia.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Placebo
Other interventionBottle of 15 mL liquid (non-effective product) will be taken once a day for 12 weeks.
JUICE HA® supplement
Other interventionBottle of 15 mL JUICE HA® supplement will be taken once a day for 12 weeks.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: JUICE HA® supplementExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From enrollment to the end of treatment at 24 weeks2
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.
Time frame
From enrollment to the end of treatment at 24 weeks3
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.
Time frame
From enrollment to the end of treatment at 24 weeks4
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.
Time frame
From enrollment to the end of treatment at 24 weeksSponsors and contacts
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Source ClinicalTrials.gov