Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
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 |
|
| Primary |
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 |
|
| Primary |
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 |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
One-leg stance test |
To evaluate static balance ability |
From Baseline, 6 weeks and 12 Weeks Assessed |
|
| Secondary |
Get Up and Go test |
To evaluate functional walking ability |
From Baseline, 6 weeks and 12 Weeks Assessed |
|
| Secondary |
Sit and Reach Test |
To evaluate lower-limb strength and flexibility |
From Baseline, 6 weeks and 12 Weeks Assessed |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
Level of Growth Differentiation Factor-15 |
Level of Growth Differentiation Factor-15 |
From Baseline, 6 weeks and 12 Weeks Assessed |
|
| Secondary |
Change in Insulin Sensitivity |
Change in fasting glucose |
From Baseline, 6 weeks and 12 Weeks Assessed |
|
| Secondary |
The serum IL-6 level |
the measurement of serum IL-6 level in blood |
From Baseline, 6 weeks and 12 Weeks Assessed |
|
| Secondary |
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 |
|
