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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hyperglycemia; Frailty; Sarcopenia; Hyperlipidemia
• Intervention / Treatment: Biological: Taiwanese whole grain job's tear (red job's tear); Biological: White job's tear

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Anchun Hwang, Doctor; Phone Number: 886-2-28712121; Email: anchun.hwang@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan, 112
    • Recruiting
    • Taipei Veterans General Hospital
    • Contact: Anchun Hwang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Taiwanese whole grain job's tear (Red job's tear)	Biological: 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
Active Comparator: White job's tear	Biological: White job's tear; 300cc drink made from white job's tear, 2 bottle/day from week 0 to week 8
Active Comparator: 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	Biological: 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; Biological: White job's tear; 300cc drink made from white job's tear, 2 bottle/day from week 0 to week 8

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of appendicular skeletal muscle index(ASMI)	ASMI=appendicular skeletal muscle mass(kg)/(height(m)2)	0, 8, 16 week
Changes of handgrip strength	Maximal handgrip strength of dominant hand (kg)	0, 8, 16 week
Changes of gait speed	Usual gait speed measured by 6-meter walking (m/s)	0, 8, 16 week
Changes of time required to finish timed up and go(TUG) test	Changes of time required to finish timed up and go(TUG) test	0, 8, 16 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of inflammation marker	defined by hsCRP	0, 8, 16 week
Changes of insulin resistance	Measured by HOMA-IR	0, 8, 16 week
Changes of LDL	Changes of LDL	0, 8, 16 week
Changes of muscle biomarker 1	Measured by serum myostatin	0, 8 week
Changes of muscle biomarker 2	Measured by serum follistatin	0, 8 week
Changes of muscle biomarker 3	Measured by serum activin A	0, 8 week

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan
• Collaborators: Taichung District Agricultural Research and Extension Station, Ministry of Agriculture, Taiwan
• Investigators: Principal Investigator: Anchun Hwang, Doctor, Taipei Veterans General Hospital, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: June 21, 2024
• First Submitted That Met QC Criteria: July 9, 2024
• First Posted (Actual): July 16, 2024

Study Record Updates

• Last Update Posted (Actual): July 16, 2024
• Last Update Submitted That Met QC Criteria: July 9, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Lipid Metabolism Disorders; Dyslipidemias; Muscular Atrophy; Atrophy; Hyperglycemia; Frailty; Sarcopenia; Hyperlipidemias
• Other Study ID Numbers: 2024-04-005C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No