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临床试验/NCT04297111
NCT04297111已完成不适用

Effect of Bacillus Coagulans on Skeletal Muscle Protein Synthesis in Response to Vegetable Protein Ingestion

University College Dublin1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2019年11月25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
12
试验地点
1
主要终点
Myofibrillar protein synthesis

研究概览

简要总结

This study will examine the effect of probiotic supplementation (Bacillus coagulans) on muscle protein synthesis in older adults in response to a plant-based diet.

The investigators hypothesize that probiotic supplementation will enhance the digestibility of plant protein, therefore increasing the proportion of ingested amino acids that appear in systemic circulation and enhancing rates of muscle protein synthesis.

详细描述

There is increasing interest in the use of plant-based proteins, both from the perspectives of global sustainability and growing consumer markets; however, plant-based proteins are known to have lower digestibility and lower ability to stimulate muscle protein synthesis (an important determinant of muscle mass) compared with animal-based proteins. Emerging evidence indicates that the probiotic Bacillus coagulans GBI-30, 6086 (GanedenBC30) can enhance plant protein digestibility. As such, Bacillus coagulans treatment may augment rates of muscle protein synthesis in response to plant-based protein intake in humans, by increasing the proportion of ingested amino acids that appear in systemic circulation after a plant meal, as circulating amino acids act as both a trigger to stimulate muscle protein synthesis in humans as well as providing the building block for new muscle tissue. An increase in muscle protein synthesis rates would be particularly critical in older adults as it is well established that one of the key mechanisms driving the loss of muscle mass with age is a reduction in muscle protein synthesis rates in response to dietary protein intake. Therefore, if probiotic supplementation can improve muscle protein synthesis rates following plant protein consumption, this indicates it may represent an effective and environmentally sensitive strategy to attenuate adverse age-related loss of muscle mass and muscle function. This is critical as the maintenance of skeletal muscle health is an important factor in the preservation of independence and quality of life as we age.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • •Age: ≥65 y
  • •Sex: males and female
  • •Body mass index (BMI) between 20-35 kg/m2
  • •Non-smokers
  • •Generally healthy according to responses to a standard health screening questionnaire

排除标准

  • •Cancer (malignancy in the past 5 years)
  • •Chronic kidney disease
  • •Liver failure
  • •Diabetes or pre-diabetes
  • •Conditions that will affect the ability to consume, digest and/or absorb the study supplement (i.e. gastrointestinal disease)
  • •Excess alcohol intake
  • •Regular resistance training
  • •Total walking incapacity
  • •Musculoskeletal or neuromuscular impairments
  • •Medications interfering with muscle metabolism
  • •Ongoing probiotic supplementation
  • •Antibiotic use in the previous 6 weeks
  • •Significant body mass loss in the 1 month period prior to the study

研究组 & 干预措施

Placebo

Placebo Comparator

Maltodextrin containing capsule

干预措施: Placebo (Other)

Probiotic

Experimental

Probiotic containing capsule

干预措施: Probiotic (Dietary Supplement)

结局指标

主要结局

Myofibrillar protein synthesis

时间窗: 6 months

Measured as fractional synthetic rate (%/day) over a 2-d period after each supplementation arm and in response to a plant-based diet

Pattern of change in plasma total amino acid, essential amino acid and leucine concentrations

时间窗: 6 months

Assessed via GC-MS.

次要结局

  • Changes in gut hormones(6 months)
  • Changes in microbiome composition(6 months)
  • Change in metabolome(6 months)
  • Changes in gut/digestion-related complaints(6 months)
  • Changes in bowel movement(6 months)
  • Changes in strength(6 months)
  • Changes in immuno-surveillance(6 months)
  • Changes in appetite(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof Helen M Roche

Professor Helen Roche

University College Dublin

研究点 (1)

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