Anxiety, Depression, Elderly, Muscle Loss
Conditions
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.
Interventions
DIETARY_SUPPLEMENTProbiotics
Lactobacillus paracasei PS23 will be used in this study
DIETARY_SUPPLEMENTheat-treated of Lactobacillus paracasei HT-PS23
heat-treated probiotic capsule contain 10 billion of Lactobacillus paracasei, 2 caps daily use
DIETARY_SUPPLEMENTPlacebo
The placebo capsule contains microcrystalline cellulose, 2 caps daily use
Sponsors
Bened Biomedical Co., Ltd.
Chi-Chang Huang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to 85 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| muscle mass | 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 |
| 30 seconds chair stand test | 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. |
| Grip strength | 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
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale for GI symptoms, VAS-GI | From Baseline, 6 weeks and 12 Weeks Assessed | 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 |
| PGI-C | From Baseline to 12 Weeks Assessed | 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). |
| 10 meter walk | From Baseline, 6 weeks and 12 Weeks Assessed | 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 |
| fat percentage | 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 fat percentage |
| One-leg stance test | From Baseline, 6 weeks and 12 Weeks Assessed | To evaluate static balance ability |
| Get Up and Go test | From Baseline, 6 weeks and 12 Weeks Assessed | To evaluate functional walking ability |
| Sit and Reach Test | From Baseline, 6 weeks and 12 Weeks Assessed | To evaluate lower-limb strength and flexibility |
| Cardiorespiratory fitness | From Baseline, 6 weeks and 12 Weeks Assessed | 2-min step test to assess the functional capacity of the respiratory and cardiovascular systems |
| Safety assessment - AST | From Baseline, 6 weeks and 12 Weeks Assessed | Safety is assessed function of liver and kidney such as AST (8-38 IU/L). |
| Generalized Anxiety Disorder 7-Item, GAD-7 | From Baseline, 6 weeks and 12 Weeks Assessed | 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 |
| Safety assessment - Bun | From Baseline, 6 weeks and 12 Weeks Assessed | Safety is assessed function of liver and kidney such as Bun (6-20 mg/dl) |
| Safety assessment - Creatinine | From Baseline, 6 weeks and 12 Weeks Assessed | Safety is assessed function of liver and kidney such as Creatinine (0.6-1.3 mg/dl) |
| Stress assessment - difference of Testosterone level | From Baseline, 6 weeks and 12 Weeks Assessed | 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 |
| Difference in Oxidative stress - blood level of HSCRP | From Baseline, 6 weeks and 12 Weeks Assessed | To assess inflammation indicators, used commercial kit human CRP (Cayman, Mich, USA) and Elisa reader (PerkinElmer, Massachusetts, USA) for analysis |
| Gut microbiota | From Baseline 12 Weeks Assessed | Collect the DNA of fecal flora to test the diversity and abundance of gut microbiota in Stool samples before and after probiotics |
| Level of Growth Differentiation Factor-15 | From Baseline, 6 weeks and 12 Weeks Assessed | Level of Growth Differentiation Factor-15 |
| Change in Insulin Sensitivity | From Baseline, 6 weeks and 12 Weeks Assessed | Change in fasting glucose |
| The serum IL-6 level | From Baseline, 6 weeks and 12 Weeks Assessed | the measurement of serum IL-6 level in blood |
| TNF-a determination using ELISA | From Baseline, 6 weeks and 12 Weeks Assessed | 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. |
| Safety assessment - ALT | From Baseline, 6 weeks and 12 Weeks Assessed | Safety is assessed function of liver and kidney such as ALT (4-44 IU/L) |
| Geriatric Depression Scale, GDS | From Baseline, 6 weeks and 12 Weeks Assessed | 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. |
| Q-LES-Q | From Baseline, 6 weeks and 12 Weeks Assessed | 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). |
Countries
Taiwan
Outcome results
None listed