TWK10 Improves Muscle Mass and Functional Performance in Frail Older Adults

NCT04893746 | Completed

• 1 other identifier: 00003
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Frail Elderly Syndrome; Sarcopenia

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Maltodextrin

TWK10-L

EXPERIMENTAL

Low dose

Dietary Supplement: Lactobacillus plantarum TWK10-L

TWK10-H

EXPERIMENTAL

High dose

Dietary Supplement: Lactobacillus plantarum TWK10-H

Interventions

Lactobacillus plantarum TWK10-L DIETARY_SUPPLEMENT

Low dose: 2x1010 CFU/day

TWK10-L

Maltodextrin DIETARY_SUPPLEMENT

0x1010 CFU/day

Placebo

Lactobacillus plantarum TWK10-H DIETARY_SUPPLEMENT

High dose: 6x1010 CFU/day

TWK10-H

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• The clinical frailty scale (Clinical Frailty Scale, CFS) assessed as frailty grade 1\~4.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan Sport University: lead
• Synbio Tech Inc.: collaborator

Study Sites (1)

National Taiwan Sport University

Taoyuan District, 333, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 34361902 DERIVED

MeSH Terms

Conditions

Sarcopenia

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Chi-Chang Huang, Ph.D

  PI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: May 14, 2021
• First Posted: May 19, 2021
• Study Start: July 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: April 30, 2021
• Last Updated: July 14, 2021

Record last verified: 2021-07

Locations

TW (1)