TWK10 Improves Muscle Mass and Functional Performance in Frail Older Adults
Primary Purpose
Frail Elderly Syndrome, Sarcopenia
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Lactobacillus plantarum TWK10-L
Maltodextrin
Lactobacillus plantarum TWK10-H
Sponsored by
About this trial
This is an interventional treatment trial for Frail Elderly Syndrome
Eligibility Criteria
Inclusion Criteria:
- The clinical frailty scale (Clinical Frailty Scale, CFS) assessed as frailty grade 1~4.
Exclusion Criteria:
- Diagnosed by the attending physician and confirmed that there is no stroke, hypertension patients and no exercise contraindications
- Can't sit to stand independently
- long-term antibiotics.
Sites / Locations
- National Taiwan Sport University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo
TWK10-L
TWK10-H
Arm Description
Low dose
High dose
Outcomes
Primary Outcome Measures
Grip strength
Use the armed grip machine (T.K.K.5401, Takei Scientific Instruments Co.,Ltd, Niigata, Japan) to measure, hold each of the left and right hands three times until they are weak, and record the maximum value
3 meter walk
Use a pyramid, a chair, and a measuring tape to measure a distance of three meters, and ask the subject to stand up from the chair, go around the pyramid and sit down, and record the time
30 second up to sit
Use a stopwatch to record the number of times get up from the chair in 30 seconds
10 meter walk
Use a pyramid and a measuring tape to measure a distance of ten meters, and ask the subject to stand up from the chair, go around the pyramid and sit down, and record the time
muscle mass
Use dual-energy X-ray absorptiometry, DXA (Lunar iDXA, GE Healthcare, IL, USA) for no-entry measurement to determine muscle mass
fat percentage
Use dual-energy X-ray absorptiometry, DXA (Lunar iDXA, GE Healthcare, IL, USA) for no-entry measurement to determine fat percentage
bone mineral density test
Use dual-energy X-ray absorptiometry, DXA (Lunar iDXA, GE Healthcare, IL, USA) for no-entry measurement to determine bone mineral density
Secondary Outcome Measures
Full Information
NCT ID
NCT04893746
First Posted
May 14, 2021
Last Updated
July 8, 2021
Sponsor
National Taiwan Sport University
Collaborators
Synbio Tech Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04893746
Brief Title
TWK10 Improves Muscle Mass and Functional Performance in Frail Older Adults
Official Title
Lactobacillus Plantarum TWK10 Improves Muscle Mass and Functional Performance in Frail Older Adults: A Randomized, Double-Blind Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
April 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Taiwan Sport University
Collaborators
Synbio Tech Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To explore the effect of "Lactobacillus plantarum TWK10 (hereinafter referred to as TWK10)" produced by synbiotech Biotechnology Co., Ltd. on alleviating and improving the aging and debilitating diseases of the elderly. Methods: It is expected to recruit 55-85-year-old senior citizens, who are assessed by the Clinical Frailty Scale (CFS) as debilitating disease grades 1 to 4 as the experimental subjects of this study. All subjects were divided into three groups according to the principle of balance order of frailty grades, namely (1) placebo group (Placebo group, average 77.4 years old), (2) supplement TWK10 probiotic 2x1010 CFU/day dose group (TWK10-L) Group, average 77.1 years old), (3) supplemented with TWK10 probiotic 6x1010 CFU/day dose group (TWK10-H group, average 79.0 years old). The experiment was supplemented for 24 consecutive weeks, and before supplementation, 6 weeks, 12 weeks, 18 weeks, the whole body composition and bone density test, as well as the functional fitness test were carried out in sequence. The items include: 3 meters walking ( Balance and gait assessment), 10-meter walking, 30-second sit-ups, and changes in the maximum grip strength of the left and right hands. Results: The experimental data showed that in the functional test, supplementing the TWK10-H group significantly improved the 3m gait balance, 10m walking, and lower limb muscle strength (30-second sit-ups) in the functional test. In terms of body composition and bone density, TWK10-H can significantly increase relative muscle mass after 18 weeks of supplementation. Conclusion: This study confirmed that supplementation of Lactobacillus plantarum TWK10 for 18 consecutive weeks can significantly promote the improvement of functional tests for the elderly, such as: 3m gait balance, 10m walking, lower limb muscle strength and grip strength, and can maintain and improve muscle mass. It has the effect of improving the frailty and muscle loss of the elderly.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frail Elderly Syndrome, Sarcopenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
TWK10-L
Arm Type
Experimental
Arm Description
Low dose
Arm Title
TWK10-H
Arm Type
Experimental
Arm Description
High dose
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus plantarum TWK10-L
Intervention Description
Low dose: 2x1010 CFU/day
Intervention Type
Dietary Supplement
Intervention Name(s)
Maltodextrin
Intervention Description
0x1010 CFU/day
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus plantarum TWK10-H
Intervention Description
High dose: 6x1010 CFU/day
Primary Outcome Measure Information:
Title
Grip strength
Description
Use the armed grip machine (T.K.K.5401, Takei Scientific Instruments Co.,Ltd, Niigata, Japan) to measure, hold each of the left and right hands three times until they are weak, and record the maximum value
Time Frame
every 6 weeks
Title
3 meter walk
Description
Use a pyramid, a chair, and a measuring tape to measure a distance of three meters, and ask the subject to stand up from the chair, go around the pyramid and sit down, and record the time
Time Frame
every 6 weeks
Title
30 second up to sit
Description
Use a stopwatch to record the number of times get up from the chair in 30 seconds
Time Frame
every 6 weeks
Title
10 meter walk
Description
Use a pyramid and a measuring tape to measure a distance of ten meters, and ask the subject to stand up from the chair, go around the pyramid and sit down, and record the time
Time Frame
every 6 weeks
Title
muscle mass
Description
Use dual-energy X-ray absorptiometry, DXA (Lunar iDXA, GE Healthcare, IL, USA) for no-entry measurement to determine muscle mass
Time Frame
every 6 weeks
Title
fat percentage
Description
Use dual-energy X-ray absorptiometry, DXA (Lunar iDXA, GE Healthcare, IL, USA) for no-entry measurement to determine fat percentage
Time Frame
every 6 weeks
Title
bone mineral density test
Description
Use dual-energy X-ray absorptiometry, DXA (Lunar iDXA, GE Healthcare, IL, USA) for no-entry measurement to determine bone mineral density
Time Frame
every 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
The clinical frailty scale (Clinical Frailty Scale, CFS) assessed as frailty grade 1~4.
Exclusion Criteria:
Diagnosed by the attending physician and confirmed that there is no stroke, hypertension patients and no exercise contraindications
Can't sit to stand independently
long-term antibiotics.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chi-Chang Huang, Ph.D
Organizational Affiliation
PI
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan Sport University
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
34361902
Citation
Lee MC, Tu YT, Lee CC, Tsai SC, Hsu HY, Tsai TY, Liu TH, Young SL, Lin JS, Huang CC. Lactobacillus plantarum TWK10 Improves Muscle Mass and Functional Performance in Frail Older Adults: A Randomized, Double-Blind Clinical Trial. Microorganisms. 2021 Jul 8;9(7):1466. doi: 10.3390/microorganisms9071466.
Results Reference
derived
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TWK10 Improves Muscle Mass and Functional Performance in Frail Older Adults
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