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

October 14, 2024 updated by: Chi-Chang Huang
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
119

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taoyuan, Taiwan, 333
        • National Taiwan Sport University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Probiotics
Probiotic capsules contain 10 billion CFU (colony forming units) of Lactobacillus paracasei, 2 caps daily use
Dietary supplement: Probiotics
Lactobacillus paracasei PS23 will be used in this study
Experimental: Heat-Treated Probiotics
heat-treated probiotic capsule contain 10 billion of Lactobacillus paracasei, 2 caps daily use
Dietary supplement: heat-treated of Lactobacillus paracasei HT-PS23
heat-treated probiotic capsule contain 10 billion of Lactobacillus paracasei, 2 caps daily use
Placebo Comparator: Placebo
The placebo capsule contains microcrystalline cellulose, 2 caps daily use
Dietary supplement: Placebo
The placebo capsule contains microcrystalline cellulose, 2 caps daily use

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
From Baseline, 6 weeks and 12 Weeks Assessed
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.
From Baseline, 6 weeks and 12 Weeks Assessed
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
From Baseline, 6 weeks and 12 Weeks Assessed

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
From Baseline, 6 weeks and 12 Weeks Assessed
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
From Baseline, 6 weeks and 12 Weeks Assessed
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
From Baseline, 6 weeks and 12 Weeks Assessed
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
From Baseline, 6 weeks and 12 Weeks Assessed
One-leg stance test
Time Frame: From Baseline, 6 weeks and 12 Weeks Assessed
To evaluate static balance ability
From Baseline, 6 weeks and 12 Weeks Assessed
Get Up and Go test
Time Frame: From Baseline, 6 weeks and 12 Weeks Assessed
To evaluate functional walking ability
From Baseline, 6 weeks and 12 Weeks Assessed
Sit and Reach Test
Time Frame: From Baseline, 6 weeks and 12 Weeks Assessed
To evaluate lower-limb strength and flexibility
From Baseline, 6 weeks and 12 Weeks Assessed
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
From Baseline, 6 weeks and 12 Weeks Assessed
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).
From Baseline, 6 weeks and 12 Weeks Assessed
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)
From Baseline, 6 weeks and 12 Weeks Assessed
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)
From Baseline, 6 weeks and 12 Weeks Assessed
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)
From Baseline, 6 weeks and 12 Weeks Assessed
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
From Baseline, 6 weeks and 12 Weeks Assessed
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
From Baseline, 6 weeks and 12 Weeks Assessed
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
From Baseline 12 Weeks Assessed
Change in Insulin Sensitivity
Time Frame: From Baseline, 6 weeks and 12 Weeks Assessed
Change in fasting glucose
From Baseline, 6 weeks and 12 Weeks Assessed
The serum IL-6 level
Time Frame: From Baseline, 6 weeks and 12 Weeks Assessed
the measurement of serum IL-6 level in blood
From Baseline, 6 weeks and 12 Weeks Assessed
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.
From Baseline, 6 weeks and 12 Weeks Assessed
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
From Baseline, 6 weeks and 12 Weeks Assessed
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.
From Baseline, 6 weeks and 12 Weeks Assessed
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).
From Baseline to 12 Weeks Assessed
Level of Growth Differentiation Factor-15
Time Frame: From Baseline, 6 weeks and 12 Weeks Assessed
Level of Growth Differentiation Factor-15
From Baseline, 6 weeks and 12 Weeks Assessed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chi-Chang Huang

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bened Biomedical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 8, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 25, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 2, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 23-006-A2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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