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

Primary Purpose

Elderly, Muscle Loss, Depression

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Probiotics
Sponsored by
Chi-Chang Huang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Elderly

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • National Taiwan Sport UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Probiotics

Heat-Treated Probiotics

Placebo

Arm Description

Probiotic capsules contain 10 billion CFU (colony forming units) of Lactobacillus paracasei, 2 caps daily use

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

The placebo capsule contains microcrystalline cellulose, 2 caps daily use

Outcomes

Primary Outcome Measures

muscle mass
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
30 seconds chair stand test will be used as a self-test. Number of stands will be counted.
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

Secondary Outcome Measures

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
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.
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).
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
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).
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
fat percentage
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
To evaluate static balance ability
Get Up and Go test
To evaluate functional walking ability
Sit and Reach Test
To evaluate lower-limb strength and flexibility
Cardiorespiratory fitness
2-min step test to assess the functional capacity of the respiratory and cardiovascular systems
Safety assessment - AST
Safety is assessed function of liver and kidney such as AST (8-38 IU/L).
Safety assessment - ALT
Safety is assessed function of liver and kidney such as ALT (4-44 IU/L)
Safety assessment - Bun
Safety is assessed function of liver and kidney such as Bun (6-20 mg/dl)
Safety assessment - Creatinine
Safety is assessed function of liver and kidney such as Creatinine (0.6-1.3 mg/dl)
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
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
Gut microbiota
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
Level of Growth Differentiation Factor-15
Change in Insulin Sensitivity
Change in fasting glucose
The serum IL-6 level
the measurement of serum IL-6 level in blood
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.

Full Information

First Posted
September 25, 2023
Last Updated
October 3, 2023
Sponsor
Chi-Chang Huang
Collaborators
Bened Biomedical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT06062472
Brief Title
Effect of Lactobacillus Paracasei PS23 on Improving Aging and Muscle Loss in the Elderly
Official Title
Effect of Lactobacillus Paracasei PS23 on Improving Aging and Muscle Loss in the Elderly
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 8, 2023 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Chi-Chang Huang
Collaborators
Bened Biomedical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elderly, Muscle Loss, Depression, Anxiety

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Probiotics
Arm Type
Experimental
Arm Description
Probiotic capsules contain 10 billion CFU (colony forming units) of Lactobacillus paracasei, 2 caps daily use
Arm Title
Heat-Treated Probiotics
Arm Type
Experimental
Arm Description
heat-treated probiotic capsule contain 10 billion of Lactobacillus paracasei, 2 caps daily use
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The placebo capsule contains microcrystalline cellulose, 2 caps daily use
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotics
Intervention Description
Both live and heat-treated of Lactobacillus paracasei will be used in this study
Primary Outcome Measure Information:
Title
muscle mass
Description
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
Title
30 seconds chair stand test
Description
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
Title
Grip strength
Description
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
Secondary Outcome Measure Information:
Title
Generalized Anxiety Disorder 7-Item, GAD-7
Description
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
Title
Geriatric Depression Scale, GDS
Description
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
Title
Q-LES-Q
Description
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
Title
Visual Analogue Scale for GI symptoms, VAS-GI
Description
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
Title
PGI-C
Description
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
Title
10 meter walk
Description
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
Title
fat percentage
Description
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
Title
One-leg stance test
Description
To evaluate static balance ability
Time Frame
From Baseline, 6 weeks and 12 Weeks Assessed
Title
Get Up and Go test
Description
To evaluate functional walking ability
Time Frame
From Baseline, 6 weeks and 12 Weeks Assessed
Title
Sit and Reach Test
Description
To evaluate lower-limb strength and flexibility
Time Frame
From Baseline, 6 weeks and 12 Weeks Assessed
Title
Cardiorespiratory fitness
Description
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
Title
Safety assessment - AST
Description
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
Title
Safety assessment - ALT
Description
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
Title
Safety assessment - Bun
Description
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
Title
Safety assessment - Creatinine
Description
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
Title
Stress assessment - difference of Testosterone level
Description
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
Title
Difference in Oxidative stress - blood level of HSCRP
Description
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
Title
Gut microbiota
Description
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
Title
Level of Growth Differentiation Factor-15
Description
Level of Growth Differentiation Factor-15
Time Frame
From Baseline, 6 weeks and 12 Weeks Assessed
Title
Change in Insulin Sensitivity
Description
Change in fasting glucose
Time Frame
From Baseline, 6 weeks and 12 Weeks Assessed
Title
The serum IL-6 level
Description
the measurement of serum IL-6 level in blood
Time Frame
From Baseline, 6 weeks and 12 Weeks Assessed
Title
TNF-a determination using ELISA
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
National Taiwan Sport University
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chi-Chang Huang
Phone
+886033283201
Ext
2409
Email
john5523@ntsu.edu.tw

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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