Probiotic-Muscle Study

Muscle Weakness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04297111
• Other study ID #: IRCEB
• Status: Completed
• Phase: N/A
• Start date: November 25, 2019
• Est. completion date: December 1, 2021

Study information

• Verified date: November 2022
• Source: University College Dublin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 1, 2021
• Est. primary completion date: October 3, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Frailty
• Muscle Weakness
• Old Age; Debility
• Protein Deposition
• Protein Deregulation

Intervention

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.

Other:
• Placebo
Maltodextrin capsule, no active ingredient

Locations

Country	Name	City	State
Ireland	University College Dublin	Dublin

Sponsors (2)

Lead Sponsor	Collaborator
University College Dublin	Kerry Group

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Pattern of change in plasma total amino acid, essential amino acid and leucine concentrations	Assessed via GC-MS.	6 months
Secondary	Changes in microbiome composition	Assessed in faecal samples via 16s rRNA analysis	6 months
Secondary	Change in metabolome	Assesed in blood and faecal water via 600 MHz nuclear magnetic resonance (NMR) spectrometry	6 months
Secondary	Changes in gut hormones	ELISA (enzyme-linked immunosorbent assay)	6 months
Secondary	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
Secondary	Changes in bowel movement	Assessed via the Bristol Stool chart, where average faecal appearance is indicated out of seven options available	6 months
Secondary	Changes in strength	Assessed via handgrip strength using a handgrip dynamometer	6 months
Secondary	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
Secondary	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