ElderlyNCT06062472
Effect of Lactobacillus Paracasei PS23 on Improving Aging and Muscle Loss in the Elderly
A study testing Probiotics and heat-treated of Lactobacillus paracasei HT-PS23 in people with Elderly and Muscle Loss, run by Chi-Chang Huang at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Elderly, Muscle Loss, Depression
- What is being tested?
- Probiotics and heat-treated of Lactobacillus paracasei HT-PS23
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 119 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Aug 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- age between 65 and 85 years old
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Elderly, Muscle Loss, Depression, Anxiety
- Being tested
- Probiotics, heat-treated of Lactobacillus paracasei HT-PS23, Placebo
- Medical subject headings
- Muscular Atrophy, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsDietary supplement
Lactobacillus paracasei PS23 will be used in this study
heat-treated of Lactobacillus paracasei HT-PS23Dietary supplement
heat-treated probiotic capsule contain 10 billion of Lactobacillus paracasei, 2 caps daily use
PlaceboDietary supplement
The placebo capsule contains microcrystalline cellulose, 2 caps daily use
| Study group | Role | What they receive |
|---|---|---|
| Probiotics | Experimental | Probiotic capsules contain 10 billion CFU (colony forming units) of Lactobacillus paracasei, 2 caps daily use Receives: Dietary Supplement: Probiotics |
| Heat-Treated Probiotics | Experimental | heat-treated probiotic capsule contain 10 billion of Lactobacillus paracasei, 2 caps daily use Receives: Dietary Supplement: heat-treated of Lactobacillus paracasei HT-PS23 |
| Placebo | Placebo comparator | The placebo capsule contains microcrystalline cellulose, 2 caps daily use Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle mass
Use dual-energy X-ray absorptiometry, DXA (Lunar iDXA, GE Healthcare, IL, USA) for no-entry measurement to determine muscle mass
Measured: From Baseline, 6 weeks and 12 Weeks Assessed
30 seconds chair stand test
30 seconds chair stand test will be used as a self-test. Number of stands will be counted.
Measured: From Baseline, 6 weeks and 12 Weeks Assessed
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
Measured: From Baseline, 6 weeks and 12 Weeks Assessed
Secondary outcomes (22)
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
Measured: From Baseline, 6 weeks and 12 Weeks Assessed
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.
Measured: From Baseline, 6 weeks and 12 Weeks Assessed
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).
Measured: From Baseline, 6 weeks and 12 Weeks Assessed
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
Measured: From Baseline, 6 weeks and 12 Weeks Assessed
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).
Measured: From Baseline to 12 Weeks Assessed
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
Measured: From Baseline, 6 weeks and 12 Weeks Assessed
fat percentage
Use dual-energy X-ray absorptiometry, DXA (Lunar iDXA, GE Healthcare, IL, USA) for no-entry measurement to determine fat percentage
Measured: From Baseline, 6 weeks and 12 Weeks Assessed
One-leg stance test
To evaluate static balance ability
Measured: From Baseline, 6 weeks and 12 Weeks Assessed
Get Up and Go test
To evaluate functional walking ability
Measured: From Baseline, 6 weeks and 12 Weeks Assessed
Sit and Reach Test
To evaluate lower-limb strength and flexibility
Measured: From Baseline, 6 weeks and 12 Weeks Assessed
Cardiorespiratory fitness
2-min step test to assess the functional capacity of the respiratory and cardiovascular systems
Measured: From Baseline, 6 weeks and 12 Weeks Assessed
Safety assessment - AST
Safety is assessed function of liver and kidney such as AST (8-38 IU/L).
Measured: From Baseline, 6 weeks and 12 Weeks Assessed
Safety assessment - ALT
Safety is assessed function of liver and kidney such as ALT (4-44 IU/L)
Measured: From Baseline, 6 weeks and 12 Weeks Assessed
Safety assessment - Bun
Safety is assessed function of liver and kidney such as Bun (6-20 mg/dl)
Measured: From Baseline, 6 weeks and 12 Weeks Assessed
Safety assessment - Creatinine
Safety is assessed function of liver and kidney such as Creatinine (0.6-1.3 mg/dl)
Measured: From Baseline, 6 weeks and 12 Weeks Assessed
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
Measured: From Baseline, 6 weeks and 12 Weeks Assessed
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
Measured: From Baseline, 6 weeks and 12 Weeks Assessed
Gut microbiota
Collect the DNA of fecal flora to test the diversity and abundance of gut microbiota in Stool samples before and after probiotics
Measured: From Baseline 12 Weeks Assessed
Level of Growth Differentiation Factor-15
Level of Growth Differentiation Factor-15
Measured: From Baseline, 6 weeks and 12 Weeks Assessed
Change in Insulin Sensitivity
Change in fasting glucose
Measured: From Baseline, 6 weeks and 12 Weeks Assessed
The serum IL-6 level
the measurement of serum IL-6 level in blood
Measured: From Baseline, 6 weeks and 12 Weeks Assessed
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.
Measured: From Baseline, 6 weeks and 12 Weeks Assessed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start8 Aug 2023
- Primary completion30 Nov 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chi-Chang Huang
- Sponsor type
- University, hospital or other
- Collaborators
- Bened Biomedical Co., Ltd.
- Responsible party
- Sponsor-investigator, Chi-Chang Huang, National Taiwan Sport University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06062472
- Sponsor's protocol ID
- 23-006-A2
- Status last verified
- Apr 2024
- First submitted
- 25 Sep 2023
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lactobacillus Paracasei PS23 on Improving Aging and Muscle Loss in the Elderly
- ClinicalTrials.gov ID
- NCT06062472
- Acronym / sponsor ID
- 23-006-A2
- Conditions
- Elderly, Muscle Loss, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Chi-Chang HuangUniversity, hospital or other
- Collaborators
- Bened Biomedical Co., Ltd.
- Study start
- 8 Aug 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 2 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Probiotics | Experimental | Dietary Supplement: ProbioticsProbiotic capsules contain 10 billion CFU (colony forming units) of Lactobacillus paracasei, 2 caps daily use |
| Heat-Treated Probiotics | Experimental | Dietary Supplement: heat-treated of Lactobacillus paracasei HT-PS23heat-treated probiotic capsule contain 10 billion of Lactobacillus paracasei, 2 caps daily use |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThe placebo capsule contains microcrystalline cellulose, 2 caps daily use |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- age between 65 and 85 years old
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticsLactobacillus paracasei PS23 will be used in this study | Dietary supplement | Probiotics |
| heat-treated of Lactobacillus paracasei HT-PS23heat-treated probiotic capsule contain 10 billion of Lactobacillus paracasei, 2 caps daily use | Dietary supplement | Heat-Treated Probiotics |
| PlaceboThe placebo capsule contains microcrystalline cellulose, 2 caps daily use | Dietary supplement | Placebo |
Primary outcome
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
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.
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
22 secondary outcomes
Generalized Anxiety Disorder 7-Item, GAD-7
Time frame: From Baseline, 6 weeks and 12 Weeks Assessed
Geriatric Depression Scale, GDS
Time frame: From Baseline, 6 weeks and 12 Weeks Assessed
Q-LES-Q
Time frame: 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
PGI-C
Time frame: From Baseline to 12 Weeks Assessed
10 meter walk
Time frame: From Baseline, 6 weeks and 12 Weeks Assessed
fat percentage
Time frame: From Baseline, 6 weeks and 12 Weeks Assessed
One-leg stance test
Time frame: From Baseline, 6 weeks and 12 Weeks Assessed
Get Up and Go test
Time frame: From Baseline, 6 weeks and 12 Weeks Assessed
Sit and Reach Test
Time frame: From Baseline, 6 weeks and 12 Weeks Assessed
Cardiorespiratory fitness
Time frame: From Baseline, 6 weeks and 12 Weeks Assessed
Safety assessment - AST
Time frame: From Baseline, 6 weeks and 12 Weeks Assessed
Safety assessment - ALT
Time frame: From Baseline, 6 weeks and 12 Weeks Assessed
Safety assessment - Bun
Time frame: From Baseline, 6 weeks and 12 Weeks Assessed
Safety assessment - Creatinine
Time frame: From Baseline, 6 weeks and 12 Weeks Assessed
Stress assessment - difference of Testosterone level
Time frame: 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
Gut microbiota
Time frame: From Baseline 12 Weeks Assessed
Level of Growth Differentiation Factor-15
Time frame: From Baseline, 6 weeks and 12 Weeks Assessed
Change in Insulin Sensitivity
Time frame: From Baseline, 6 weeks and 12 Weeks Assessed
The serum IL-6 level
Time frame: From Baseline, 6 weeks and 12 Weeks Assessed
TNF-a determination using ELISA
Time frame: From Baseline, 6 weeks and 12 Weeks Assessed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics and heat-treated of Lactobacillus paracasei HT-PS23 in people with Elderly and Muscle Loss, run by Chi-Chang Huang at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
muscle mass (time frame: From Baseline, 6 weeks and 12 Weeks Assessed). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.