The Clinical Effectiveness of Taiwanese Whole Grain Job's Tear on Muscle Health, Blood Glucose and Lipid Levels- a Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- Changes of appendicular skeletal muscle index(ASMI)
Study Overview
Brief Summary
Background: This investigation aims to explore efficacy of Taiwanese whole grain job's tear on muscle health and blood glucose and lipid levels in community-dwelling older adults.
Methods: An open-label, 16-week, randomized controlled, cross-over trial involving participants with subject complaint of slower gait or weakness or fall in last year were recruited. The intervention group consumed Taiwanese whole grain job's tear (red job's tear) or white job's tear. Assessments included laboratory tests, functional assessments, and body composition.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 60 Years to 95 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •People who aged 60-95 years
- •Patients with following characteristics:
- •feeling loss in activity detecting decline in self's walking speed. feeling tired of doing everything. having fall event in last year. People willing to follow the program and cooperate with us for following tracking.
- •People who are neither vegan nor vegetarian People agree and be able to sign the informed consent.
Exclusion Criteria
- •People with any disease affecting their limbs, including:
- •having fracture on limbs in the past 6 months having severe arthritis in the past 6 months any other whom PI recognized as weak control of their nervous system( e.g.: Parkinson's disease and stroke).
- •People with intermittent limp caused by peripheral artery diseases People with weak control of mental disorder People with weak control of Cardiopulmonary disease People with weak control of Malignant tumor People with weak control of kidney diseases (eGFR <60ml/min/1.73) People with Visual impairment and Hearing disorder which cannot help to complete the program.
- •People who have underwent hormone treatment and planned to undergo hormone treatment during program session.
- •Any other condition that PI recognized as not suitable
Outcomes
Primary Outcomes
Changes of appendicular skeletal muscle index(ASMI)
Time Frame: 0, 8, 16 week
ASMI=appendicular skeletal muscle mass(kg)/(height(m)2)
Changes of handgrip strength
Time Frame: 0, 8, 16 week
Maximal handgrip strength of dominant hand (kg)
Changes of gait speed
Time Frame: 0, 8, 16 week
Usual gait speed measured by 6-meter walking (m/s)
Changes of time required to finish timed up and go(TUG) test
Time Frame: 0, 8, 16 week
Changes of time required to finish timed up and go(TUG) test
Secondary Outcomes
- Changes of inflammation marker(0, 8, 16 week)
- Changes of insulin resistance(0, 8, 16 week)
- Changes of muscle biomarker 1(0, 8 week)
- Changes of muscle biomarker 3(0, 8 week)
- Changes of LDL(0, 8, 16 week)
- Changes of muscle biomarker 2(0, 8 week)