Clinical trial NCT04297111: Probiotic-Muscle Study
Official title: Effect of Bacillus Coagulans on Skeletal Muscle Protein Synthesis in Response to Vegetable Protein Ingestion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Old Age; Debility
Muscle Weakness
Protein Deregulation
Protein Deposition
Lead sponsor: University College Dublin
Sponsor class: OTHER
Collaborators: name: Kerry Group
First posted: 2020-03-05
Enrollment: 12
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The study will be a randomised, double-blind, placebo-controlled crossover study. Each participant will undergo 8 weeks of Bacillus coagulans (probiotic) supplementation and 8 weeks of placebo supplementation in a counterbalanced order. There will be a 5-day trial period at the end of each supplementation phase. There will be a wash-out period of 8 weeks between probiotic and placebo supplementation.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Cancer (malignancy in the past 5 years)
* CVD
* 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)
* Smokers
* 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

Primary outcomes:
measure: Myofibrillar protein synthesis
timeFrame: 6 months
measure: Pattern of change in plasma total amino acid, essential amino acid and leucine concentrations
timeFrame: 6 months
Secondary outcomes:
measure: Changes in microbiome composition
timeFrame: 6 months
measure: Change in metabolome
timeFrame: 6 months
measure: Changes in gut hormones
timeFrame: 6 months
measure: Changes in gut/digestion-related complaints
timeFrame: 6 months
measure: Changes in bowel movement
timeFrame: 6 months
measure: Changes in strength
timeFrame: 6 months
measure: Changes in immuno-surveillance
timeFrame: 6 months
measure: Changes in appetite
timeFrame: 6 months
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: University College Dublin
Study officials:
affiliation: University College Dublin
name: Helen Roche, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University College Dublin
name: Caoielann Murphy, PhD
role: STUDY_DIRECTOR
References: