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临床试验/NCT04985877
NCT04985877已完成不适用

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 University3 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2021年3月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
132
试验地点
3
主要终点
Impact of LCS on the Change of Gut Microbiota

研究概览

简要总结

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.

详细描述

1. Subject Enrollment The definition of sarcopenia is based on the algorithm of Asian Working Group for Sarcopenia (AWGS).

  1. Muscle mass: measured by using Inbody S10 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 <5.7 kg/m2
  1. Handgrip strength: measured by electronic hand grip dynamometer. Low handgrip strength was defined as:
  • Men: <28 kg
  • Women: <18 kg
  1. 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) and one of (2), or (3)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None (Participant, Care Provider)

入排标准

年龄范围
65 Years 至 85 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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 <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)
  • 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 <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)

排除标准

  • of Three groups:
  • 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

研究组 & 干预措施

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.

干预措施: Yakult 300 LIGHT Fermented Milk (Dietary Supplement)

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.

结局指标

主要结局

Impact of LCS on the Change of Gut Microbiota

时间窗: 12 week

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.

次要结局

  • 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)
  • Impact of LCS on the Change of Anti-oxidant Biomarker(12 week)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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