Effect of Fermented Milk Containing Lactobacillus Casei Strain Shirota in Sarcopenia Elderly

NCT04985877 | Completed Results

• 1 other identifier: N202010025
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 3

Brief Summary

Sarcopenia, which refers to the progressive loss of skeletal muscle mass and strength, shares many characteristics with other disease states typically associated with risks of falling and fracture, including osteoporosis, frailty, and obesity. Sarcopenia often is linked to an increase in connective tissue, muscle steatosis, impaired muscle metabolism, an increase in inflammatory markers, an increased stiffness of myofibers, slower kinetics in establishing myosin-actin crossing bridges, increased oxidative stress, mitochondria dysfunction, hormonal imbalance, and decreased capillary flow. In addition to the Lactobacillus casei strain, Shirota is a well-known probiotic strain that has been approved and is generally recognized as safe by the United States Food and Drug Administration. L. casei strain Shirota (LCS) has been suggested to confer health benefits. Investigators found that LCS decelerated age-related muscle loss via ensuring mitochondrial function in Senescence-Accelerated Mouse Prone 8 (SAMP8) mice. Investigators also found that 3-Indolepropionic Acid (IPA) is a microbiota-derived metabolite from a healthy intestinal gut. IPA is also a protective factor for the progression of chronic kidney disease in the Chinese population. This clinical trial focuses on the effect of fermented milk containing LCS on sarcopenia in elderly Taiwanese individuals. Investigators focus on the topic of the interaction of LCS with the diversity of the gut microbiota, microbiota-derived metabolites, and protein utilization. The proposal will have four research goals. First, investigators try to investigate whether long term supplementation LCS could restructure the gut microbiota composition and gut microbial metabolites to against Aging related -Gut Dysbiosis in elderly. Second, investigators also try to link the LCS play an important role on muscle loss and alternation of gut microbiota composition. Third, investigators try to study the LCS effect of muscle deterioration with aging, and highlight the two underpinning mechanisms (ROS and protein utilization) regulating declines in muscle mass and function. Fourth, Since IPA is important Microbiota-derived metabolites in health gut, investigators try to investigate whether LCS could play an important role on modulation of IPA production in GI. Fifth, investigators hope that investigators can through gut microbiota composition found some selective microbiota clusters perform positively correlation with IPA.

Conditions

Sarcopenia; Inflammation; Aging

Keywords

Sarcopenia; Inflammation; Aging; Lactobacillus casei strain Shirota

Outcome Measures

Primary Outcomes (1)

• Impact of LCS on the Change of Gut Microbiota

  The V1-V9 region of the 16S rRNA gene was amplified by PCR following the Illumina 16S Metagenomic Sequencing Library Preparation protocol and sequenced on an Illumina MiSeq 2000 platform. Data analysis used QIIME2 with UPARSE for OTU clustering (97% similarity), Shannon index for alpha diversity, weighted PCoA for beta diversity, and LEfSe via Galaxy for differential analysis. In sarcopenia patients, Synergistaceae and Oscillibacter are elevated while Bifidobacterium is reduced. Post-intervention improvement (decreased Synergistaceae/Oscillibacter, increased Bifidobacterium) alleviates dysbiosis, lowers inflammation, and enhances gut-muscle axis function. This shift boosts SCFA production, muscle protein synthesis, grip strength, and mass while reducing pathogen-induced insulin resistance for metabolic recovery and symptom relief.

  12 week

Secondary Outcomes (6)

• Impact of LCS on the Change of Sarcopenia Markers (Handgrip)

  12 week

• Impact of LCS on the Change of Sarcopenia Markers (Walk Speed)

  12 weeks

• Impact of LCS on the Change of Sarcopenia Markers (Chair Stand Test & TUG Test)

  12 week

• Impact of LCS on the Change of Sarcopenia Markers (SPPB Score)

  12 weeks

• Impact of LCS on the Change of Inflammatory Biomarker

  12 week

Study Arms (3)

Sarcopenia plus LcS group(LcS)

EXPERIMENTAL

LcS group must conform to inclusion criteria of LcS group and exclusion criteria. NS group need to intervene Yakult light 300 supplementation. NS group need to finish pre test and post test.

Dietary Supplement: Yakult 300 LIGHT Fermented Milk

Sarcopenia group(SC)

NO INTERVENTION

SC group must conform to inclusion criteria of SC group and exclusion criteria. NS group dosen't need to intervene Yakult light 300 supplementation. NS group need to finish pre test and post test.

non-sarcopenia group(NS)

NO INTERVENTION

NS group must conform to inclusion criteria of NS group and exclusion criteria. NS group dosen't need to intervene Yakult light 300 supplementation. NS group only need to finish the post test.

Interventions

Yakult 300 LIGHT Fermented Milk DIETARY_SUPPLEMENT

2 bottles of fermented Milk containing Lactobacillus casei Strain Shirota per day, Intervention for 12 weeks.

Sarcopenia plus LcS group(LcS)

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Age between 65 and 85 years
• No use of hormonal replacement therapy (women)
• No hospital admissions within the last 3 months
• Sarcopenia criteria:
• (1) Muscle mass: measured by using InbodyS10 and standardized by height, shown by skeletal muscle index \[SMI=appendicular muscle mass (kg)/height (m2)\]. Low muscle mass was defined as:
• Men: SMI \<7.0 kg/m2
• Women: SMI \<5.4 kg/m2 (2) Handgrip strength: measured by electronic hand grip dynamometer. Low handgrip strength was defined as:
• Men: \<28 kg
• Women: \<18 kg (3) Limb strength: measured by Time for 5 times for chair stand method. Low limb strength was defined as:
• Time for 5 times for chair stand: ≧12s Sarcopenia was defined by (1), (2) or (3) Sarcopenia plus Lactobacillus casei strain Shirota (LcS)
• Age between 65 and 85 years
• No use of hormonal replacement therapy (women)
• No hospital admissions within the last 3 months
• Sarcopenia criteria:
• (1) Muscle mass: measured by using InbodyS10 and standardized by height, shown by skeletal muscle index \[SMI=appendicular muscle mass (kg)/height (m2)\]. Low muscle mass was defined as:

You may not qualify if:

• Active cancer: currently receiving cancer treatment or have received cancer treatment within the last 3 months
• Weight change ≥ 5% or weight change ≥ 5 kg within the past 3 months
• BMI \> 35 kg/m2
• Disease requiring chronic use of prescription corticosteroids
• History of ischemic or hemorrhage stroke
• Unstable or uncontrollable hypertension (\>180/110 mmHg)
• Doing hemodialysis or peritoneal dialysis within the last 3 months
• Participation in a structured physical exercise training program within the past 2 year; previous use of creatinine supplementation; use of drugs that can affect bone metabolism (e.g., glucocorticoids, bisphosphonates, vitamin D or calcium).
• Antibiotics were used in the past 3 months.
• Products of probiotic were used in the past 2 weeks.
• Living abroad for one month in the past 3 months
• Hyperthyroidism without medication therapy
• Allergic to milk

Sponsors & Collaborators

• Taipei Medical University: lead
• Yakult Honsha Co., LTD: collaborator

Study Sites (3)

Taipei Medical University Hospital

Taipei, 110, Taiwan

Location

Taipei Medical University

Taipei, 110, Taiwan

Location

Wanfang Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Sarcopenia; Inflammation

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pathologic Processes

Results Point of Contact

• Title: Hui-Yu, Hunag
• Organization: Taipei Medical University

maggieh323@tmu.edu.tw

0227361661

Study Officials

• Huang Hui-Yu, PhD

  Taipei Medical University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: August 2, 2021
• Study Start: March 23, 2021
• Primary Completion: February 23, 2023
• Study Completion: February 23, 2023
• Last Updated: February 17, 2026
• Results First Posted: February 17, 2026

Record last verified: 2026-01

Locations

TW (3)