N/A
N=132
Effect of Fermented Milk Containing Lactobacillus Casei Strain Shirota in Sarcopenia Elderly
Sarcopenia · Inflammation · Aging
Bottom Line
View on ClinicalTrials.gov: NCT04985877 ↗Enrolled (actual)
132
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcome: Primary: Impact of LCS on the Change of Gut Microbiota — 0.023577513; 0.248239465; 0.003810442; 0.10325558 % of total Bacteria — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Yakult 300 LIGHT Fermented Milk (Dietary_supplement)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Taipei Medical University
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Impact of LCS on the Change of Gut Microbiota |
0.023577513; 0.248239465; 0.003810442; 0.10325558; 0.374706279; 0.173954697 | <0.05 sig |
| SECONDARY Impact of LCS on the Change of Sarcopenia Markers (Handgrip) |
22.17; 18.95; 19.07 | 0.05 |
| SECONDARY Impact of LCS on the Change of Sarcopenia Markers (Walk Speed) |
0.89; 0.82; 1.08 | 0.05 |
| SECONDARY Impact of LCS on the Change of Sarcopenia Markers (Chair Stand Test & TUG Test) |
12.91; 14.95; 12.31; 10.12; 11.18; 9.06 | <0.05 sig |
| SECONDARY Impact of LCS on the Change of Sarcopenia Markers (SPPB Score) |
11; 9; 11 | 0.05 |
| SECONDARY Impact of LCS on the Change of Inflammatory Biomarker |
5.97; 29.30; 7.94; 22520; 5050; 16600 | <0.05 sig |
| SECONDARY Impact of LCS on the Change of Anti-oxidant Biomarker |
39; 38; 26; 111; 106; 105 | <0.05 sig |
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.
Eligibility Criteria
Sarcopenia without treatment
Inclusion Criteria
- 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 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
Data sourced from ClinicalTrials.gov (NCT04985877). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.