TWK10 Improves Muscle Mass and Functional Performance in Frail Older Adults

NCT ID: NCT04893746

Last Updated: 2021-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2021-04-30

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.

Detailed Description

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Conditions

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Frail Elderly Syndrome Sarcopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Maltodextrin

Intervention Type DIETARY_SUPPLEMENT

0x1010 CFU/day

TWK10-L

Low dose

Group Type EXPERIMENTAL

Lactobacillus plantarum TWK10-L

Intervention Type DIETARY_SUPPLEMENT

Low dose: 2x1010 CFU/day

TWK10-H

High dose

Group Type EXPERIMENTAL

Lactobacillus plantarum TWK10-H

Intervention Type DIETARY_SUPPLEMENT

High dose: 6x1010 CFU/day

Interventions

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Lactobacillus plantarum TWK10-L

Low dose: 2x1010 CFU/day

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin

0x1010 CFU/day

Intervention Type DIETARY_SUPPLEMENT

Lactobacillus plantarum TWK10-H

High dose: 6x1010 CFU/day

Intervention Type DIETARY_SUPPLEMENT

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.
Minimum Eligible Age

65 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Synbio Tech Inc.

INDUSTRY

Sponsor Role collaborator

National Taiwan Sport University

OTHER

Sponsor Role lead

Responsible Party

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Chi-Chang Huang

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chi-Chang Huang, Ph.D

Role: PRINCIPAL_INVESTIGATOR

PI

Locations

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National Taiwan Sport University

Taoyuan District, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type DERIVED
PMID: 34361902 (View on PubMed)

Other Identifiers

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00003

Identifier Type: -

Identifier Source: org_study_id

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