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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
119
Lactobacillus paracasei PS23 will be used in this study
heat-treated probiotic capsule contain 10 billion of Lactobacillus paracasei, 2 caps daily use
The placebo capsule contains microcrystalline cellulose, 2 caps daily use
National Taiwan Sport University
Taoyuan, Taiwan
muscle mass
Use dual-energy X-ray absorptiometry, DXA (Lunar iDXA, GE Healthcare, IL, USA) for no-entry measurement to determine muscle mass
Time frame: 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.
Time frame: 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
Time frame: From Baseline, 6 weeks and 12 Weeks Assessed
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
Time frame: 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.
Time frame: From Baseline, 6 weeks and 12 Weeks Assessed
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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).
Time frame: 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
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: From Baseline, 6 weeks and 12 Weeks Assessed
One-leg stance test
To evaluate static balance ability
Time frame: From Baseline, 6 weeks and 12 Weeks Assessed
Get Up and Go test
To evaluate functional walking ability
Time frame: From Baseline, 6 weeks and 12 Weeks Assessed
Sit and Reach Test
To evaluate lower-limb strength and flexibility
Time frame: 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
Time frame: 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).
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From Baseline 12 Weeks Assessed
Level of Growth Differentiation Factor-15
Level of Growth Differentiation Factor-15
Time frame: From Baseline, 6 weeks and 12 Weeks Assessed
Change in Insulin Sensitivity
Change in fasting glucose
Time frame: From Baseline, 6 weeks and 12 Weeks Assessed
The serum IL-6 level
the measurement of serum IL-6 level in blood
Time frame: 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.
Time frame: From Baseline, 6 weeks and 12 Weeks Assessed