Probiotic-Muscle Study

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

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.

Study Overview

• Status: Completed
• Conditions: Muscle Weakness; Old Age; Debility; Protein Deposition; Protein Deregulation
• Intervention / Treatment: Other: Placebo; Dietary supplement: Probiotic

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland
    • University College Dublin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Maltodextrin containing capsule	Other: Placebo; Maltodextrin capsule, no active ingredient
Experimental: Probiotic; Probiotic containing capsule	Dietary supplement: Probiotic; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myofibrillar protein synthesis	Measured as fractional synthetic rate (%/day) over a 2-d period after each supplementation arm and in response to a plant-based diet	6 months
Pattern of change in plasma total amino acid, essential amino acid and leucine concentrations	Assessed via GC-MS.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in microbiome composition	Assessed in faecal samples via 16s rRNA analysis	6 months
Change in metabolome	Assesed in blood and faecal water via 600 MHz nuclear magnetic resonance (NMR) spectrometry	6 months
Changes in gut hormones	ELISA (enzyme-linked immunosorbent assay)	6 months
Changes in gut/digestion-related complaints	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).	6 months
Changes in bowel movement	Assessed via the Bristol Stool chart, where average faecal appearance is indicated out of seven options available	6 months
Changes in strength	Assessed via handgrip strength using a handgrip dynamometer	6 months
Changes in immuno-surveillance	Assessed via the Common Cold Questonnaire (CCQ), where minimum and maximum values are: none, and severe respectively (higher score means worse outcome).	6 months
Changes in appetite	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)	6 months

Collaborators and Investigators

• Sponsor: University College Dublin
• Collaborators: Kerry Group
• Investigators: Principal Investigator: Helen Roche, PhD, University College Dublin; Study Director: Caoielann Murphy, PhD, University College Dublin

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2019
• Primary Completion (Actual): October 3, 2020
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: March 3, 2020
• First Submitted That Met QC Criteria: March 3, 2020
• First Posted (Actual): March 5, 2020

Study Record Updates

• Last Update Posted (Actual): November 3, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Weakness; Frailty
• Other Study ID Numbers: IRCEB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Research results will be published in a peer-reviewed journal once the study has finalised and the data has been analized.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No