Whole Grain Job's Tear, Muscle Health, Blood Glucose and Lipid Level

Taipei Veterans General Hospital

Status and phase: Enrolling; Phase 2

Conditions: Hyperlipidemia; Hyperglycemia; Frailty; Sarcopenia

Treatments: Biological: Taiwanese whole grain job's tear (red job's tear); Biological: White job's tear

Study type: Interventional

Funder types: Other

Identifiers

NCT06503172

2024-04-005C

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 60 to 95 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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80 participants in 3 patient groups

Taiwanese whole grain job's tear (Red job's tear)

Experimental group

Description:

Taiwanese whole grain job's tear (Red job's tear)

Treatment:

Biological: Taiwanese whole grain job's tear (red job's tear)

White job's tear

Active Comparator group

Description:

White job's tear

Treatment:

Biological: White job's tear

Active comparator group

Active Comparator group

Description:

Active comparator group * serve as comparator group from week 0 to week 8, * assigned to red job's tear or white job's tear group from week 8 to week 16

Treatment:

Biological: White job's tear

Biological: Taiwanese whole grain job's tear (red job's tear)