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

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.

Study Overview

• Status: Completed
• Conditions: Frail Elderly Syndrome; Sarcopenia
• Intervention / Treatment: Dietary supplement: Maltodextrin; Dietary supplement: Lactobacillus plantarum TWK10-L; Dietary supplement: Lactobacillus plantarum TWK10-H

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan, Taiwan, 333
    • National Taiwan Sport University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 90 years (OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Dietary supplement: Maltodextrin; 0x1010 CFU/day
EXPERIMENTAL: TWK10-L; Low dose	Dietary supplement: Lactobacillus plantarum TWK10-L; Low dose: 2x1010 CFU/day
EXPERIMENTAL: TWK10-H; High dose	Dietary supplement: Lactobacillus plantarum TWK10-H; High dose: 6x1010 CFU/day

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Taiwan Sport University
• Collaborators: Synbio Tech Inc.
• Investigators: Principal Investigator: Chi-Chang Huang, Ph.D, PI

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2020
• Primary Completion (ACTUAL): December 31, 2020
• Study Completion (ACTUAL): April 30, 2021

Study Registration Dates

• First Submitted: May 14, 2021
• First Submitted That Met QC Criteria: May 14, 2021
• First Posted (ACTUAL): May 19, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 14, 2021
• Last Update Submitted That Met QC Criteria: July 8, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: 00003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No