Muscle Weakness, Old Age; Debility, Protein Deposition, Protein Deregulation
Conditions
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.
Interventions
DIETARY_SUPPLEMENTProbiotic
GanedenBC30 (Bacillus coagulans GBI-30, 6086) capsule made of 1 billion colony forming units (cfu). Description: pure cell mass of an L-(+) lactic acid-producing, gram-positive, spore-forming shaped bacterium that is aerobic to microaerophilic. Maltodextrin used as filler.
OTHERPlacebo
Maltodextrin capsule, no active ingredient
Sponsors
Kerry Group
University College Dublin
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in gut hormones | 6 months | ELISA (enzyme-linked immunosorbent assay) |
| 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 microbiome composition | 6 months | Assessed in faecal samples via 16s rRNA analysis |
| 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) |
| Changes in strength | 6 months | Assessed via handgrip strength using a handgrip dynamometer |
| Change in metabolome | 6 months | Assesed in blood and faecal water via 600 MHz nuclear magnetic resonance (NMR) spectrometry |
Countries
Ireland
Outcome results
None listed