CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 132 enrolled
Drug / intervention
Yakult 300 LIGHT Fermented Milkdietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04985877
NCT04985877N/ACompleted

The Effect of Fermented Milk Containing Lactobacillus Casei Strain Shirota on Sarcopenia in Elderly Taiwanese: Interactions With the Nutrients Utilization, Diversity of Gut Microbiota, Microbiota-derived Metabolites and Muscle Loss

Taipei Medical University·interventional·Posted Aug 2, 2021·Updated Feb 17, 2026

In Brief

A clinical study evaluating Yakult 300 LIGHT Fermented Milk for Sarcopenia and 2 related conditions. Completed, enrolled 132 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesTaiwan

Timeline

N/ACompletedFinished
20222023202420252026
First PostedAug 2, 2021
Enrollment StartMar 23, 2021
Primary CompletionFeb 23, 2023
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 4.9 years ago

Interventions

Yakult 300 LIGHT Fermented Milkdietary

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