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

NCT ID: NCT06503172

Last Updated: 2024-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-14

Study Completion Date

2024-12-31

Brief Summary

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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

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Conditions

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Sarcopenia Frailty Hyperglycemia Hyperlipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

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

Group Type EXPERIMENTAL

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

Intervention Type BIOLOGICAL

300cc drink made from red job's tear, 2 bottle/day from week 0 to week 8

White job's tear

White job's tear

Group Type ACTIVE_COMPARATOR

White job's tear

Intervention Type BIOLOGICAL

300cc drink made from white job's tear, 2 bottle/day from week 0 to week 8

Active comparator group

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type BIOLOGICAL

300cc drink made from red job's tear, 2 bottle/day from week 0 to week 8

White job's tear

Intervention Type BIOLOGICAL

300cc drink made from white job's tear, 2 bottle/day from week 0 to week 8

Interventions

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

300cc drink made from red job's tear, 2 bottle/day from week 0 to week 8

Intervention Type BIOLOGICAL

White job's tear

300cc drink made from white job's tear, 2 bottle/day from week 0 to week 8

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Taichung District Agricultural Research and Extension Station, Ministry of Agriculture, Taiwan

UNKNOWN

Sponsor Role collaborator

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anchun Hwang, Doctor

Role: PRINCIPAL_INVESTIGATOR

Taipei Veterans General Hospital, Taiwan

Locations

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Taipei Veterans General hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Anchun Hwang, Doctor

Role: CONTACT

886-2-28712121

Facility Contacts

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Anchun Hwang

Role: primary

Other Identifiers

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2024-04-005C

Identifier Type: -

Identifier Source: org_study_id

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