Clinical trial NCT06062472: Effect of Lactobacillus Paracasei PS23 on Improving Aging and Muscle Loss in the Elderly
Official title: Effect of Lactobacillus Paracasei PS23 on Improving Aging and Muscle Loss in the Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly
Muscle Loss
Depression
Anxiety
Lead sponsor: National Taiwan Sport University
Sponsor class: OTHER
Collaborators: name: Bened Biomedical Co., Ltd.
First posted: 2023-10-02
Enrollment: 119
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study refers to the supplementation of PS23 in human experiments to help the elderly maintain muscle mass, delay muscle loss, promote physical activity, and delay the occurrence of disability and debilitation in elderly people.

Detailed description: Taiwan has become an aging society in recent years. There are important issues to attenuate aging and activate the potential capacity of elderly population. The physical function of middle-aged and older people will degenerate with age and produce age-related diseases. Common symptoms are organ function deterioration, and old age disability caused by malnutrition and muscle loss is also a common care problem. Therefore, how to prevent the complications of muscle loss is one of the important ten years of geriatric research. Although past research has been confirmed, it can improve the debilitating condition of the elderly through nutrition counseling and exercise intervention. However, there is not much in-depth discussion on how probiotics can improve muscle loss and delay symptoms in elderly people. Therefore, this study refers to the supplementation of PS23 in human experiments to help the elderly maintain muscle mass, delay muscle loss, promote physical activity, and delay the occurrence of disability and debilitation in elderly people. One hundred and twenty elderly people will be recruited and then divided into three groups with 40 people in each group: (A) placebo group, (B) PS23 probiotic group, (C) PS23-HT prebiotic group, supplemented for 12 weeks. The diet record, functional test and muscle mass will be carried out every six weeks after the start, to understand whether PS23 is effective in improving muscle loss and weakness in elderly people.

Eligibility criteria: Inclusion Criteria:

* age between 65 and 85 years old

Exclusion Criteria:

* Have taken antibiotics within one month or are receiving antibiotic treatment
* Have used probiotic products in powder, capsule or tablet form within two weeks (except for yogurt, yogurt, Yakut and other related foods)
* People allergic to lactic acid bacteria products
* Patients diagnosed with stroke or hypertension (systolic blood pressure greater than 139, diastolic blood pressure greater than 89)
* Exclusion of limbs and hips that have been replaced with artificial joints
* Persons with incapacity/insufficient decision-making ability
* Who has been determines that it is not suitable to participate in the research.

Primary outcomes:
measure: muscle mass
timeFrame: From Baseline, 6 weeks and 12 Weeks Assessed
measure: 30 seconds chair stand test
timeFrame: From Baseline, 6 weeks and 12 Weeks Assessed
measure: Grip strength
timeFrame: From Baseline, 6 weeks and 12 Weeks Assessed
Secondary outcomes:
measure: Generalized Anxiety Disorder 7-Item, GAD-7
timeFrame: From Baseline, 6 weeks and 12 Weeks Assessed
measure: Geriatric Depression Scale, GDS
timeFrame: From Baseline, 6 weeks and 12 Weeks Assessed
measure: Q-LES-Q
timeFrame: From Baseline, 6 weeks and 12 Weeks Assessed
measure: Visual Analogue Scale for GI symptoms, VAS-GI
timeFrame: From Baseline, 6 weeks and 12 Weeks Assessed
measure: PGI-C
timeFrame: From Baseline to 12 Weeks Assessed
measure: 10 meter walk
timeFrame: From Baseline, 6 weeks and 12 Weeks Assessed
measure: fat percentage
timeFrame: From Baseline, 6 weeks and 12 Weeks Assessed
measure: One-leg stance test
timeFrame: From Baseline, 6 weeks and 12 Weeks Assessed
measure: Get Up and Go test
timeFrame: From Baseline, 6 weeks and 12 Weeks Assessed
measure: Sit and Reach Test
timeFrame: From Baseline, 6 weeks and 12 Weeks Assessed
measure: Cardiorespiratory fitness
timeFrame: From Baseline, 6 weeks and 12 Weeks Assessed
measure: Safety assessment - AST
timeFrame: From Baseline, 6 weeks and 12 Weeks Assessed
measure: Safety assessment - ALT
timeFrame: From Baseline, 6 weeks and 12 Weeks Assessed
measure: Safety assessment - Bun
timeFrame: From Baseline, 6 weeks and 12 Weeks Assessed
measure: Safety assessment - Creatinine
timeFrame: From Baseline, 6 weeks and 12 Weeks Assessed
measure: Stress assessment - difference of Testosterone level
timeFrame: From Baseline, 6 weeks and 12 Weeks Assessed
measure: Difference in Oxidative stress - blood level of HSCRP
timeFrame: From Baseline, 6 weeks and 12 Weeks Assessed
measure: Gut microbiota
timeFrame: From Baseline 12 Weeks Assessed
measure: Level of Growth Differentiation Factor-15
timeFrame: From Baseline, 6 weeks and 12 Weeks Assessed
measure: Change in Insulin Sensitivity
timeFrame: From Baseline, 6 weeks and 12 Weeks Assessed
measure: The serum IL-6 level
timeFrame: From Baseline, 6 weeks and 12 Weeks Assessed
measure: TNF-a determination using ELISA
timeFrame: From Baseline, 6 weeks and 12 Weeks Assessed
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: National Taiwan Sport University
Study officials:
References: