MedPath

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

Phase 2
Recruiting
Conditions
Hyperglycemia
Frailty
Sarcopenia
Hyperlipidemia
Interventions
Biological: Taiwanese whole grain job's tear (red job's tear)
Biological: White job's tear
Registration Number
NCT06503172
Lead Sponsor
Taipei Veterans General Hospital, Taiwan
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
80
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Taiwanese whole grain job's tear (Red job's tear)Taiwanese whole grain job's tear (red job's tear)Taiwanese whole grain job's tear (Red job's tear)
White job's tearWhite job's tearWhite job's tear
Active comparator groupTaiwanese whole grain job's tear (red job's tear)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
Active comparator groupWhite job's tearActive 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
Primary Outcome Measures
NameTimeMethod
Changes of appendicular skeletal muscle index(ASMI)0, 8, 16 week

ASMI=appendicular skeletal muscle mass(kg)/(height(m)2)

Changes of handgrip strength0, 8, 16 week

Maximal handgrip strength of dominant hand (kg)

Changes of gait speed0, 8, 16 week

Usual gait speed measured by 6-meter walking (m/s)

Changes of time required to finish timed up and go(TUG) test0, 8, 16 week

Changes of time required to finish timed up and go(TUG) test

Secondary Outcome Measures
NameTimeMethod
Changes of inflammation marker0, 8, 16 week

defined by hsCRP

Changes of insulin resistance0, 8, 16 week

Measured by HOMA-IR

Changes of muscle biomarker 10, 8 week

Measured by serum myostatin

Changes of muscle biomarker 30, 8 week

Measured by serum activin A

Changes of LDL0, 8, 16 week

Changes of LDL

Changes of muscle biomarker 20, 8 week

Measured by serum follistatin

Trial Locations

Locations (1)

Taipei Veterans General hospital

🇨🇳

Taipei, Taiwan

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