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

NCT06503172 | Recruiting Phase 2

• 1 other identifier: 2024-04-005C
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia; Frailty; Hyperglycemia; Hyperlipidemia

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• Changes of inflammation marker

  0, 8, 16 week

• Changes of insulin resistance

  0, 8, 16 week

• Changes of LDL

  0, 8, 16 week

• Changes of muscle biomarker 1

  0, 8 week

• Changes of muscle biomarker 2

  0, 8 week

Study Arms (3)

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

EXPERIMENTAL

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

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

White job's tear

ACTIVE COMPARATOR

White job's tear

Biological: White job's tear

Active comparator group

ACTIVE COMPARATOR

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); Biological: White job's tear

Interventions

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

Active comparator group; Taiwanese whole grain job's tear (Red job's tear)

White job's tear BIOLOGICAL

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

Active comparator group; White job's tear

Eligibility Criteria

• Age: 60 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead
• Taichung District Agricultural Research and Extension Station, Ministry of Agriculture, Taiwan: collaborator

Study Sites (1)

Taipei Veterans General hospital

Taipei, 112, Taiwan

RECRUITING

MeSH Terms

Conditions

Sarcopenia; Frailty; Hyperglycemia; Hyperlipidemias

Condition Hierarchy (Ancestors)

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

Study Officials

• Anchun Hwang, Doctor

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anchun Hwang, Doctor

CONTACT

886-2-28712121; anchun.hwang@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: July 16, 2024
• Study Start: June 14, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)