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

NCT ID: NCT06062472

Last Updated: 2024-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-08

Study Completion Date

2023-12-31

Brief Summary

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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

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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

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Elderly Muscle Loss Depression Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Probiotics

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

Group Type EXPERIMENTAL

Probiotics

Intervention Type DIETARY_SUPPLEMENT

Lactobacillus paracasei PS23 will be used in this study

Heat-Treated Probiotics

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

Group Type EXPERIMENTAL

heat-treated of Lactobacillus paracasei HT-PS23

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

The placebo capsule contains microcrystalline cellulose, 2 caps daily use

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

The placebo capsule contains microcrystalline cellulose, 2 caps daily use

Interventions

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Placebo

The placebo capsule contains microcrystalline cellulose, 2 caps daily use

Intervention Type DIETARY_SUPPLEMENT

Probiotics

Lactobacillus paracasei PS23 will be used in this study

Intervention Type DIETARY_SUPPLEMENT

heat-treated of Lactobacillus paracasei HT-PS23

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bened Biomedical Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Chi-Chang Huang

OTHER

Sponsor Role lead

Responsible Party

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Chi-Chang Huang

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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National Taiwan Sport University

Taoyuan District, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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23-006-A2

Identifier Type: -

Identifier Source: org_study_id

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