TWK10 Improves Muscle Mass and Functional Performance in Frail Older Adults

Study Overview
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Brief Summary
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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.

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

Conditions
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Frail Elderly Syndrome, Sarcopenia

Intervention / Treatment
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* Dietary Supplement: Lactobacillus plantarum TWK10-L
* Dietary Supplement: Maltodextrin
* Dietary Supplement: Lactobacillus plantarum TWK10-H


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Dietary Supplement: Maltodextrin<br>* 0x1010 CFU/day<br>|
| Experimental: TWK10-L<br>Low dose | Dietary Supplement: Lactobacillus plantarum TWK10-L<br>* Low dose: 2x1010 CFU/day<br>|
| Experimental: TWK10-H<br>High dose | Dietary Supplement: Lactobacillus plantarum TWK10-H<br>* High dose: 6x1010 CFU/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | every 6 weeks | 
| 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 | every 6 weeks | 
| 30 second up to sit | Use a stopwatch to record the number of times get up from the chair in 30 seconds | every 6 weeks | 
| 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 | every 6 weeks | 
| muscle mass | Use dual-energy X-ray absorptiometry, DXA (Lunar iDXA, GE Healthcare, IL, USA) for no-entry measurement to determine muscle mass | every 6 weeks | 
| fat percentage | Use dual-energy X-ray absorptiometry, DXA (Lunar iDXA, GE Healthcare, IL, USA) for no-entry measurement to determine fat percentage | every 6 weeks | 
| 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 | every 6 weeks |