Clinical trial NCT06503172: Whole Grain Job's Tear, Muscle Health, Blood Glucose and Lipid Level
Official title: The Clinical Effectiveness of Taiwanese Whole Grain Job's Tear on Muscle Health, Blood Glucose and Lipid Levels- a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Sarcopenia
Frailty
Hyperglycemia
Hyperlipidemia
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
Collaborators: name: Taichung District Agricultural Research and Extension Station, Ministry of Agriculture, Taiwan
First posted: 2024-07-16
Enrollment: 80
Sex: ALL
Minimum age (years): 60
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes of appendicular skeletal muscle index(ASMI)
timeFrame: 0, 8, 16 week
measure: Changes of handgrip strength
timeFrame: 0, 8, 16 week
measure: Changes of gait speed
timeFrame: 0, 8, 16 week
measure: Changes of time required to finish timed up and go(TUG) test
timeFrame: 0, 8, 16 week
Secondary outcomes:
measure: Changes of inflammation marker
timeFrame: 0, 8, 16 week
measure: Changes of insulin resistance
timeFrame: 0, 8, 16 week
measure: Changes of LDL
timeFrame: 0, 8, 16 week
measure: Changes of muscle biomarker 1
timeFrame: 0, 8 week
measure: Changes of muscle biomarker 2
timeFrame: 0, 8 week
measure: Changes of muscle biomarker 3
timeFrame: 0, 8 week
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General hospital
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Anchun Hwang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: