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TWK10 Improves Muscle Mass and Functional Performance in Frail Older Adults

Lactobacillus Plantarum TWK10 Improves Muscle Mass and Functional Performance in Frail Older Adults: A Randomized, Double-Blind Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04893746
Enrollment
68
Registered
2021-05-19
Start date
2020-07-01
Completion date
2021-04-30
Last updated
2021-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frail Elderly Syndrome, Sarcopenia

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.

Interventions

DIETARY_SUPPLEMENTLactobacillus plantarum TWK10-L

Low dose: 2x1010 CFU/day

DIETARY_SUPPLEMENTMaltodextrin

0x1010 CFU/day

DIETARY_SUPPLEMENTLactobacillus plantarum TWK10-H

High dose: 6x1010 CFU/day

Sponsors

Synbio Tech Inc.
CollaboratorINDUSTRY
National Taiwan Sport University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
65 Years to 90 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Grip strengthevery 6 weeksUse 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 walkevery 6 weeksUse 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 sitevery 6 weeksUse a stopwatch to record the number of times get up from the chair in 30 seconds
10 meter walkevery 6 weeksUse 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 massevery 6 weeksUse dual-energy X-ray absorptiometry, DXA (Lunar iDXA, GE Healthcare, IL, USA) for no-entry measurement to determine muscle mass
fat percentageevery 6 weeksUse dual-energy X-ray absorptiometry, DXA (Lunar iDXA, GE Healthcare, IL, USA) for no-entry measurement to determine fat percentage
bone mineral density testevery 6 weeksUse dual-energy X-ray absorptiometry, DXA (Lunar iDXA, GE Healthcare, IL, USA) for no-entry measurement to determine bone mineral density

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026