NCT04893746

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: National Taiwan Sport University · Academic / Other
• Sex: All
• Age: 65 Years – 90 Years
• Healthy volunteers: Accepted

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.

Conditions

• Frail Elderly Syndrome
• Sarcopenia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lactobacillus plantarum TWK10-L	Low dose: 2x1010 CFU/day
DIETARY_SUPPLEMENT	Maltodextrin	0x1010 CFU/day
DIETARY_SUPPLEMENT	Lactobacillus plantarum TWK10-H	High dose: 6x1010 CFU/day

Timeline

• Start date: 2020-07-01
• Primary completion: 2020-12-31
• Completion: 2021-04-30
• First posted: 2021-05-19
• Last updated: 2021-07-14

Locations

1 site across 1 country: Taiwan