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Completed

NCT Number: NCT04893746

TWK10 Improves Muscle Mass and Functional Performance in Frail Older Adults

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.

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Key information

Conditions

Frail Elderly Syndrome Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan Sport University

Taoyuan, 333, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lactobacillus plantarum TWK10-L

Dietary Supplement

Low dose: 2x1010 CFU/day

Maltodextrin

Dietary Supplement

0x1010 CFU/day

Lactobacillus plantarum TWK10-H

Dietary Supplement

High dose: 6x1010 CFU/day

Primary outcomes

  1. Grip strength

    Time frame: every 6 weeks

    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

  2. 3 meter walk

    Time frame: every 6 weeks

    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

  3. 30 second up to sit

    Time frame: every 6 weeks

    Use a stopwatch to record the number of times get up from the chair in 30 seconds

  4. 10 meter walk

    Time frame: every 6 weeks

    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

  5. muscle mass

    Time frame: every 6 weeks

    Use dual-energy X-ray absorptiometry, DXA (Lunar iDXA, GE Healthcare, IL, USA) for no-entry measurement to determine muscle mass

  6. fat percentage

    Time frame: every 6 weeks

    Use dual-energy X-ray absorptiometry, DXA (Lunar iDXA, GE Healthcare, IL, USA) for no-entry measurement to determine fat percentage

  7. bone mineral density test

    Time frame: every 6 weeks

    Use dual-energy X-ray absorptiometry, DXA (Lunar iDXA, GE Healthcare, IL, USA) for no-entry measurement to determine bone mineral density

Sponsors and collaborators

Lead sponsor

National Taiwan Sport University

Other

Collaborators

  • Synbio Tech Inc.

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
May 19, 2021
Registry last updated
Jul 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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