TWK10 Improves Muscle Mass and Functional Performance in Frail Older Adults

National Taiwan Sport University

Status: Completed

Conditions: Sarcopenia; Frail Elderly Syndrome

Treatments: Dietary Supplement: Maltodextrin; Dietary Supplement: Lactobacillus plantarum TWK10-H; Dietary Supplement: Lactobacillus plantarum TWK10-L

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04893746

00003

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Ages: 65 to 90 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

68 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Maltodextrin

TWK10-L

Experimental group

Description:

Low dose

Treatment:

Dietary Supplement: Lactobacillus plantarum TWK10-L

TWK10-H

Experimental group

Description:

High dose

Treatment:

Dietary Supplement: Lactobacillus plantarum TWK10-H