NCT06062472

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
119

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 8, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 2, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

October 16, 2024

Status Verified

April 1, 2024

Enrollment Period

4 months

First QC Date

September 25, 2023

Last Update Submit

October 14, 2024

Conditions

ElderlyMuscle LossDepressionAnxiety

Outcome Measures

Primary Outcomes (3)

  • muscle mass

    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

    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

    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 Outcomes (22)

  • Generalized Anxiety Disorder 7-Item, GAD-7

    From Baseline, 6 weeks and 12 Weeks Assessed

  • Geriatric Depression Scale, GDS

    From Baseline, 6 weeks and 12 Weeks Assessed

  • Q-LES-Q

    From Baseline, 6 weeks and 12 Weeks Assessed

  • Visual Analogue Scale for GI symptoms, VAS-GI

    From Baseline, 6 weeks and 12 Weeks Assessed

  • PGI-C

    From Baseline to 12 Weeks Assessed

  • +17 more secondary outcomes

Study Arms (3)

Probiotics

EXPERIMENTAL

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

Dietary Supplement: Probiotics

Heat-Treated Probiotics

EXPERIMENTAL

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

Dietary Supplement: heat-treated of Lactobacillus paracasei HT-PS23

Placebo

PLACEBO COMPARATOR

The placebo capsule contains microcrystalline cellulose, 2 caps daily use

Dietary Supplement: Placebo

Interventions

ProbioticsDIETARY_SUPPLEMENT

Lactobacillus paracasei PS23 will be used in this study

Probiotics
heat-treated of Lactobacillus paracasei HT-PS23DIETARY_SUPPLEMENT

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

Heat-Treated Probiotics
PlaceboDIETARY_SUPPLEMENT

The placebo capsule contains microcrystalline cellulose, 2 caps daily use

Placebo

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • age between 65 and 85 years old

You may not qualify if:

  • 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)
  • Persons with incapacity/insufficient decision-making ability
  • Who has been determines that it is not suitable to participate in the research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan Sport University

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Muscular AtrophyDepressionAnxiety Disorders

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsBehavioral SymptomsBehaviorMental Disorders

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 25, 2023

First Posted

October 2, 2023

Study Start

August 8, 2023

Primary Completion

November 30, 2023

Study Completion

December 31, 2023

Last Updated

October 16, 2024

Record last verified: 2024-04

Locations

TW(1)