TWK10 Improves Muscle Mass and Functional Performance in Frail Older Adults

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04893746
• Other study ID #: 00003
• Status: Completed
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: April 30, 2021

Study information

• Verified date: July 2021
• Source: National Taiwan Sport University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: April 30, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Frail Elderly Syndrome
• Sarcopenia

Intervention

Dietary Supplement:
• Lactobacillus plantarum TWK10-L
Low dose: 2x1010 CFU/day
• Maltodextrin
0x1010 CFU/day
• Lactobacillus plantarum TWK10-H
High dose: 6x1010 CFU/day

Locations

Country	Name	City	State
Taiwan	National Taiwan Sport University	Taoyuan

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan Sport University	SYNBIO TECH INC.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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