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

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: Completed
• Conditions: Depression; Anxiety; Elderly; Muscle Loss
• Intervention / Treatment: Dietary supplement: Probiotics

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: Interventional
• Enrollment (Actual): 119
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotics; Probiotic capsules contain 10 billion CFU (colony forming units) of Lactobacillus paracasei, 2 caps daily use	Dietary supplement: Probiotics; Both live and heat-treated of Lactobacillus paracasei 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: Probiotics; Both live and heat-treated of Lactobacillus paracasei will be used in this study
Placebo Comparator: Placebo; The placebo capsule contains microcrystalline cellulose, 2 caps daily use	Dietary supplement: Probiotics; Both live and heat-treated of Lactobacillus paracasei will be used in this study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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	From Baseline, 6 weeks and 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	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	From Baseline, 6 weeks and 12 Weeks Assessed
One-leg stance test	To evaluate static balance ability	From Baseline, 6 weeks and 12 Weeks Assessed
Get Up and Go test	To evaluate functional walking ability	From Baseline, 6 weeks and 12 Weeks Assessed
Sit and Reach Test	To evaluate lower-limb strength and flexibility	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	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).	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)	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)	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)	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	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	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	From Baseline 12 Weeks Assessed
Change in Insulin Sensitivity	Change in fasting glucose	From Baseline, 6 weeks and 12 Weeks Assessed
The serum IL-6 level	the measurement of serum IL-6 level in blood	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.	From Baseline, 6 weeks and 12 Weeks Assessed
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	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.	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).	From Baseline to 12 Weeks Assessed
Level of Growth Differentiation Factor-15	Level of Growth Differentiation Factor-15	From Baseline, 6 weeks and 12 Weeks Assessed

Collaborators and Investigators

• Sponsor: Chi-Chang Huang
• Collaborators: Bened Biomedical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2023
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: September 25, 2023
• First Submitted That Met QC Criteria: September 25, 2023
• First Posted (Actual): October 2, 2023

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID 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