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Completed

NCT Number: NCT06062472

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

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.

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Key information

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan Sport University

Taoyuan, 333, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Probiotics

Dietary Supplement

Lactobacillus paracasei PS23 will be used in this study

heat-treated of Lactobacillus paracasei HT-PS23

Dietary Supplement

heat-treated probiotic capsule contain 10 billion of Lactobacillus paracasei, 2 caps daily use

Placebo

Dietary Supplement

The placebo capsule contains microcrystalline cellulose, 2 caps daily use

Primary outcomes

  1. 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

  2. 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.

  3. 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

  1. Generalized Anxiety Disorder 7-Item, GAD-7

    Time frame: 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

  2. Geriatric Depression Scale, GDS

    Time frame: 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.

  3. Q-LES-Q

    Time frame: 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).

  4. Visual Analogue Scale for GI symptoms, VAS-GI

    Time frame: 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

  5. PGI-C

    Time frame: 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).

  6. 10 meter walk

    Time frame: 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

  7. fat percentage

    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 fat percentage

  8. One-leg stance test

    Time frame: From Baseline, 6 weeks and 12 Weeks Assessed

    To evaluate static balance ability

  9. Get Up and Go test

    Time frame: From Baseline, 6 weeks and 12 Weeks Assessed

    To evaluate functional walking ability

  10. Sit and Reach Test

    Time frame: From Baseline, 6 weeks and 12 Weeks Assessed

    To evaluate lower-limb strength and flexibility

  11. Cardiorespiratory fitness

    Time frame: From Baseline, 6 weeks and 12 Weeks Assessed

    2-min step test to assess the functional capacity of the respiratory and cardiovascular systems

  12. Safety assessment - AST

    Time frame: From Baseline, 6 weeks and 12 Weeks Assessed

    Safety is assessed function of liver and kidney such as AST (8-38 IU/L).

  13. Safety assessment - ALT

    Time frame: From Baseline, 6 weeks and 12 Weeks Assessed

    Safety is assessed function of liver and kidney such as ALT (4-44 IU/L)

  14. Safety assessment - Bun

    Time frame: From Baseline, 6 weeks and 12 Weeks Assessed

    Safety is assessed function of liver and kidney such as Bun (6-20 mg/dl)

  15. Safety assessment - Creatinine

    Time frame: 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)

  16. Stress assessment - difference of Testosterone level

    Time frame: 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

  17. Difference in Oxidative stress - blood level of HSCRP

    Time frame: 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

  18. Gut microbiota

    Time frame: 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

  19. Level of Growth Differentiation Factor-15

    Time frame: From Baseline, 6 weeks and 12 Weeks Assessed

    Level of Growth Differentiation Factor-15

  20. Change in Insulin Sensitivity

    Time frame: From Baseline, 6 weeks and 12 Weeks Assessed

    Change in fasting glucose

  21. The serum IL-6 level

    Time frame: From Baseline, 6 weeks and 12 Weeks Assessed

    the measurement of serum IL-6 level in blood

  22. TNF-a determination using ELISA

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Chi-Chang Huang

Other

Collaborators

  • Bened Biomedical Co., Ltd.

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 2, 2023
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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