Clinical trial NCT04893746: 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
Overall status: COMPLETED
Phase: NA
Conditions: Frail Elderly Syndrome
Sarcopenia
Lead sponsor: National Taiwan Sport University
Sponsor class: OTHER
Collaborators: name: Synbio Tech Inc.
First posted: 2021-05-19
Enrollment: 68
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Grip strength
timeFrame: every 6 weeks
measure: 3 meter walk
timeFrame: every 6 weeks
measure: 30 second up to sit
timeFrame: every 6 weeks
measure: 10 meter walk
timeFrame: every 6 weeks
measure: muscle mass
timeFrame: every 6 weeks
measure: fat percentage
timeFrame: every 6 weeks
measure: bone mineral density test
timeFrame: every 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: National Taiwan Sport University
Study officials:
affiliation: PI
name: Chi-Chang Huang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
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.