Probiotic-Muscle Study
- Conditions
- Protein DepositionOld Age; DebilityProtein DeregulationMuscle Weakness
- Interventions
- Other: PlaceboDietary Supplement: Probiotic
- Registration Number
- NCT04297111
- Lead Sponsor
- University College Dublin
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo Placebo Maltodextrin containing capsule Probiotic Probiotic Probiotic containing capsule
- Primary Outcome Measures
Name Time Method Myofibrillar protein synthesis 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 6 months Assessed via GC-MS.
- Secondary Outcome Measures
Name Time Method Changes in gut hormones 6 months ELISA (enzyme-linked immunosorbent assay)
Changes in microbiome composition 6 months Assessed in faecal samples via 16s rRNA analysis
Change in metabolome 6 months Assesed in blood and faecal water via 600 MHz nuclear magnetic resonance (NMR) spectrometry
Changes in gut/digestion-related complaints 6 months Assessed via the Gastrointestinal Symptom Rating Scale (GSRS), where minimum and maximum values are: no discomfort at all, and very severe discomfort respectively (higher score means worse outcome).
Changes in bowel movement 6 months Assessed via the Bristol Stool chart, where average faecal appearance is indicated out of seven options available
Changes in strength 6 months Assessed via handgrip strength using a handgrip dynamometer
Changes in immuno-surveillance 6 months Assessed via the Common Cold Questonnaire (CCQ), where minimum and maximum values are: none, and severe respectively (higher score means worse outcome).
Changes in appetite 6 months Assessed via the Visual Analogue Scale (VAS) during 3 days of the trial period and after the protein-containing beverage, where the left and right side of the scale indicate: not hungry at all, and extremely hungry respectively (there is not an assigned better or worse outcome for this scale)
Trial Locations
- Locations (1)
University College Dublin
🇮🇪Dublin, Ireland