Effect of Lactobacillus Paracasei PS23 on Improving Aging and Muscle Loss in the Elderly

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Lactobacillus Paracasei PS23 on Improving Aging and Muscle Loss in the Elderly

Conditions
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Elderly, Muscle Loss, Depression, Anxiety

Intervention / Treatment
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* Dietary Supplement: Probiotics


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotics<br>Probiotic capsules contain 10 billion CFU (colony forming units) of Lactobacillus paracasei, 2 caps daily use | Dietary Supplement: Probiotics<br>* Both live and heat-treated of Lactobacillus paracasei will be used in this study<br>|
| Experimental: Heat-Treated Probiotics<br>heat-treated probiotic capsule contain 10 billion of Lactobacillus paracasei, 2 caps daily use | Dietary Supplement: Probiotics<br>* Both live and heat-treated of Lactobacillus paracasei will be used in this study<br>|
| Placebo Comparator: Placebo<br>The placebo capsule contains microcrystalline cellulose, 2 caps daily use | Dietary Supplement: Probiotics<br>* Both live and heat-treated of Lactobacillus paracasei will be used in this study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| muscle mass | Use dual-energy X-ray absorptiometry, DXA (Lunar iDXA, GE Healthcare, IL, USA) for no-entry measurement to determine muscle mass | From Baseline, 6 weeks and 12 Weeks Assessed | 
| 30 seconds chair stand test | 30 seconds chair stand test will be used as a self-test. Number of stands will be counted. | From Baseline, 6 weeks and 12 Weeks Assessed | 
| Grip strength | Use the armed grip machine to measure, hold each of the left and right hands three times until they are weak, and record the maximum value | From Baseline, 6 weeks and 12 Weeks Assessed | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Generalized Anxiety Disorder 7-Item, GAD-7 | The GAD-7 Anxiety Questionnaire involves 7 items assessing how often participants have felt bothered by anxiety-related problems over the past two weeks. Each item is rated on a Likert scale from 0 (not at all) to 3 (nearly every day). The total score is the sum of responses and ranges from 0-21; where 0-4 = minimal anxiety; 5-9 = mild anxiety; 10-14 = moderate anxiety; 15-21 = severe anxiety | From Baseline, 6 weeks and 12 Weeks Assessed | 
| Geriatric Depression Scale, GDS | It consists of 30 questions questioning the mood in the last week. This short form consists of 15 questions questioning the mood of the patient. The answers are given according to the feelings in the last week; The answers are yes or no and 1 point is given for yes or no answers depending on the question. For the long form: Normal 0 - 10, Mild 11 - 20, Moderate to Severe 21 - 30.For the short form: Normal 0 - 4, Mild 5 - 9, Moderate to Severe 10 - 15. | From Baseline, 6 weeks and 12 Weeks Assessed | 
| Q-LES-Q | Participants who receive app-CBT will have greater improvement on quality of life, assessed using The Quality of Life, Enjoyment, and Satisfaction Questionnaire - Short Form (Q-LES-Q). The Q-LES-Q-SF is a self-report measure of subjective quality of life, containing Likert items ranging from 1 (Very Poor) to 5 (Very Good). Total scores are presented as a percentage of the maximum value (i.e., ranging from 0 to 100, with higher scores indicating greater quality of life). | From Baseline, 6 weeks and 12 Weeks Assessed | 
| Visual Analogue Scale for GI symptoms, VAS-GI | Visual Analogue Scale for GI symptoms, VAS-GI (visual analogue scale, VAS 0-10) was designed to measure the response of symptoms and well-being in patients after taking probiotics | From Baseline, 6 weeks and 12 Weeks Assessed | 
| PGI-C | The PGIC is a scale participants use to rate the level of change they have experienced following treatment. The PGIC is a 7-point scale from 1 (very much better) to 7 (very much worse). | From Baseline to 12 Weeks Assessed | 
| 10 meter walk | 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 | From Baseline, 6 weeks and 12 Weeks Assessed | 
| fat percentage | Use dual-energy X-ray absorptiometry, DXA (Lunar iDXA, GE Healthcare, IL, USA) for no-entry measurement to determine fat percentage | From Baseline, 6 weeks and 12 Weeks Assessed | 
| One-leg stance test | To evaluate static balance ability | From Baseline, 6 weeks and 12 Weeks Assessed | 
| Get Up and Go test | To evaluate functional walking ability | From Baseline, 6 weeks and 12 Weeks Assessed | 
| Sit and Reach Test | To evaluate lower-limb strength and flexibility | From Baseline, 6 weeks and 12 Weeks Assessed | 
| Cardiorespiratory fitness | 2-min step test to assess the functional capacity of the respiratory and cardiovascular systems | From Baseline, 6 weeks and 12 Weeks Assessed | 
| Safety assessment - AST | Safety is assessed function of liver and kidney such as AST (8-38 IU/L). | From Baseline, 6 weeks and 12 Weeks Assessed | 
| Safety assessment - ALT | Safety is assessed function of liver and kidney such as ALT (4-44 IU/L) | From Baseline, 6 weeks and 12 Weeks Assessed | 
| Safety assessment - Bun | Safety is assessed function of liver and kidney such as Bun (6-20 mg/dl) | From Baseline, 6 weeks and 12 Weeks Assessed | 
| Safety assessment - Creatinine | Safety is assessed function of liver and kidney such as Creatinine (0.6-1.3 mg/dl) | From Baseline, 6 weeks and 12 Weeks Assessed | 
| Stress assessment - difference of Testosterone level | To assess inflammation indicators, used commercial kit human Testosterone (Cayman, Mich, USA) and Elisa reader (PerkinElmer, Massachusetts, USA) for analysis Male 265-923 (in ng/dl) Female 15-70 (in ng/dl) for 19 years and older | From Baseline, 6 weeks and 12 Weeks Assessed | 
| Difference in Oxidative stress - blood level of HSCRP | To assess inflammation indicators, used commercial kit human CRP (Cayman, Mich, USA) and Elisa reader (PerkinElmer, Massachusetts, USA) for analysis | From Baseline, 6 weeks and 12 Weeks Assessed | 
| Gut microbiota | Collect the DNA of fecal flora to test the diversity and abundance of gut microbiota in Stool samples before and after probiotics | From Baseline 12 Weeks Assessed | 
| Level of Growth Differentiation Factor-15 | Level of Growth Differentiation Factor-15 | From Baseline, 6 weeks and 12 Weeks Assessed | 
| Change in Insulin Sensitivity | Change in fasting glucose | From Baseline, 6 weeks and 12 Weeks Assessed | 
| The serum IL-6 level | the measurement of serum IL-6 level in blood | From Baseline, 6 weeks and 12 Weeks Assessed | 
| TNF-a determination using ELISA | A serum level of TNF-a was determined by quantitative sandwich enzyme immunoassay (R&D Systems, Inc., Minneapolis, MN, USA) guided by to the manufacturer's instructions. The intensity of the color was measured at 490 nm. | From Baseline, 6 weeks and 12 Weeks Assessed |