TWK10 Improves Muscle Mass and Functional Performance in Frail Older Adults

NCT04893746 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2021-07-14

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Synbio Tech Inc.

    collaborator INDUSTRY
  • National Taiwan Sport University

    lead OTHER

Principal Investigators

  • Chi-Chang Huang, Ph.D · PI

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2020-12-31
Completion
2021-04-30

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04893746 on ClinicalTrials.gov