Effect of Lactobacillus Paracasei PS23 on Improving Aging and Muscle Loss in the Elderly
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 119
- Locations
- 1
- Primary Endpoint
- 30 seconds chair stand test
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 65 Years to 85 Years (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Probiotics
Probiotic capsules contain 10 billion CFU (colony forming units) of Lactobacillus paracasei, 2 caps daily use
Intervention: Probiotics (Dietary Supplement)
Heat-Treated Probiotics
heat-treated probiotic capsule contain 10 billion of Lactobacillus paracasei, 2 caps daily use
Intervention: heat-treated of Lactobacillus paracasei HT-PS23 (Dietary Supplement)
Placebo
The placebo capsule contains microcrystalline cellulose, 2 caps daily use
Intervention: Placebo (Dietary Supplement)
Outcomes
Primary Outcomes
30 seconds chair stand test
Time Frame: From Baseline, 6 weeks and 12 Weeks Assessed
30 seconds chair stand test will be used as a self-test. Number of stands will be counted.
muscle mass
Time Frame: From Baseline, 6 weeks and 12 Weeks Assessed
Use dual-energy X-ray absorptiometry, DXA (Lunar iDXA, GE Healthcare, IL, USA) for no-entry measurement to determine muscle mass
Grip strength
Time Frame: From Baseline, 6 weeks and 12 Weeks Assessed
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
Secondary Outcomes
- Stress assessment - difference of Testosterone level(From Baseline, 6 weeks and 12 Weeks Assessed)
- Gut microbiota(From Baseline 12 Weeks Assessed)
- Visual Analogue Scale for GI symptoms, VAS-GI(From Baseline, 6 weeks and 12 Weeks Assessed)
- Get Up and Go test(From Baseline, 6 weeks and 12 Weeks Assessed)
- Sit and Reach Test(From Baseline, 6 weeks and 12 Weeks Assessed)
- Safety assessment - Bun(From Baseline, 6 weeks and 12 Weeks Assessed)
- Q-LES-Q(From Baseline, 6 weeks and 12 Weeks Assessed)
- Safety assessment - AST(From Baseline, 6 weeks and 12 Weeks Assessed)
- Safety assessment - ALT(From Baseline, 6 weeks and 12 Weeks Assessed)
- Change in Insulin Sensitivity(From Baseline, 6 weeks and 12 Weeks Assessed)
- fat percentage(From Baseline, 6 weeks and 12 Weeks Assessed)
- One-leg stance test(From Baseline, 6 weeks and 12 Weeks Assessed)
- Safety assessment - Creatinine(From Baseline, 6 weeks and 12 Weeks Assessed)
- Difference in Oxidative stress - blood level of HSCRP(From Baseline, 6 weeks and 12 Weeks Assessed)
- The serum IL-6 level(From Baseline, 6 weeks and 12 Weeks Assessed)
- Generalized Anxiety Disorder 7-Item, GAD-7(From Baseline, 6 weeks and 12 Weeks Assessed)
- Geriatric Depression Scale, GDS(From Baseline, 6 weeks and 12 Weeks Assessed)
- PGI-C(From Baseline to 12 Weeks Assessed)
- 10 meter walk(From Baseline, 6 weeks and 12 Weeks Assessed)
- Cardiorespiratory fitness(From Baseline, 6 weeks and 12 Weeks Assessed)
- Level of Growth Differentiation Factor-15(From Baseline, 6 weeks and 12 Weeks Assessed)
- TNF-a determination using ELISA(From Baseline, 6 weeks and 12 Weeks Assessed)
Investigators
Chi-Chang Huang
Principal Investigator
National Taiwan Sport University