Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06503172

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Sarcopenia Atrophy Dyslipidemias Frailty Glucose Metabolism Disorders Hyperglycemia Hyperlipidemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Taipei Veterans General hospital

Taipei, 112, Taiwan

Location status: Recruiting

Location contact

Anchun Hwang

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Biological

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

White job's tear

Biological

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

Primary outcomes

  1. Changes of appendicular skeletal muscle index(ASMI)

    Time frame: 0, 8, 16 week

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

  2. Changes of handgrip strength

    Time frame: 0, 8, 16 week

    Maximal handgrip strength of dominant hand (kg)

  3. Changes of gait speed

    Time frame: 0, 8, 16 week

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

  4. 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

  1. Changes of inflammation marker

    Time frame: 0, 8, 16 week

    defined by hsCRP

  2. Changes of insulin resistance

    Time frame: 0, 8, 16 week

    Measured by HOMA-IR

  3. Changes of LDL

    Time frame: 0, 8, 16 week

    Changes of LDL

  4. Changes of muscle biomarker 1

    Time frame: 0, 8 week

    Measured by serum myostatin

  5. Changes of muscle biomarker 2

    Time frame: 0, 8 week

    Measured by serum follistatin

  6. Changes of muscle biomarker 3

    Time frame: 0, 8 week

    Measured by serum activin A

Study contacts

Contact information is provided by the study sponsor or research team.

Anchun Hwang, Doctor

CONTACT

[email protected]

886-2-28712121

Sponsors and collaborators

Lead sponsor

Taipei Veterans General Hospital, Taiwan

Other Gov

Collaborators

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

Registry information

Official study title

The Clinical Effectiveness of Taiwanese Whole Grain Job's Tear on Muscle Health, Blood Glucose and Lipid Levels- a Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 16, 2024
Registry last updated
Jul 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.