Trial Outcomes & Findings for Effect of Fermented Milk Containing Lactobacillus Casei Strain Shirota in Sarcopenia Elderly (NCT NCT04985877)

Subjects are recruited from Taipei Medical University Hospital, Shuang Ho Hospital, Taipei Municipal Wanfang Hospital, and Taipei Community Care (Stone Soup). Participants who fail the first screening are classified as NS group. Those who pass second screening will be randomized into SC or LcS group.

First screening: (1)Calf Circumference(cm): Men\<34, Women\<33；(2)SARC-F Score≥4. Second screening: (3)SMI: Men\<7.0, Women\<5.7；(4)Handgrip Strength(kg): Men\<28, Women\<18；(5)Limb Strength Test≥12 sec. Sarcopenia is defined as meeting (3) and at least one of (4) or (5). If any participants withdraw during the trial, recruitment will continue until each group reaches a total of 40 completed cases.

Race and Ethnicity were not collected from any participant.

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.

Handgrip: The measurement used electronic hand grip dynamometer. Low handgrip strength was defined as Men: \<28 kg; Women: \<18kg.

Walk speed: The time required for participants to walk 6 meters along the line.

Chair stand test (second): Participants sat and stood five times, and time was calculated using a timer. Low limb strength was defined time ≧12s. TUG:Participants were instructed to stand up from the chair, walk 3 meters forward and go back to sit on the chair. Low Physical performance was defined ≧ 20s.

The Short Physical Performance Battery (SPPB) is a validated objective assessment tool developed by the National Institute on Aging to evaluate lower extremity function in older adults. It comprises three standardized components administered in sequence: a balance test (side-by-side, semi-tandem, and tandem stands), a 4-meter gait speed test, and a five-times chair stand test, each scored from 0-4 based on time or ability, yielding a total score of 0-12. Higher scores (10-12: minimal limitations; 4-6: moderate; 0-3: severe) indicate better physical performance and predict lower risks of mobility disability, falls, hospitalization, and mortality. The SPPB takes \~10 minutes, requires minimal equipment, and demonstrates excellent reliability for clinical and research use in geriatric populations, including sarcopenia studies. Low Physical performance was defined ≦ 9 scores

Serum pro-inflammatory cytokines (IL-6 and TNF-α) and anti-inflammatory cytokines (IL-10, IL-17 and TGF-β) were determined by using ELISA Kits (Elabscience Biotechnology Inc) via ELISA reader (BioTek, PowerWave XS2, City, State, USA).

Superoxide dismutase (SOD) (E-BC-K019, Elabscience Biotechnology Inc.), Glutathione peroxidase (GPx) (E-BC-K096, Elabscience Inc.) and Catalase (CAT) (E-BC-K031, Elabscience Biotechnology Inc.) are antioxidant enzymes in human. Enzymatic activity in serum was determined by using ELISA Kits via ELISA reader (BioTek, PowerWave XS2, City, State, USA).