Skip to main content
OpenTrials
Completed

NCT Number: NCT04297111

Probiotic-Muscle Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University College Dublin

Dublin, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic

Dietary Supplement

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.

Placebo

Other

Maltodextrin capsule, no active ingredient

Primary outcomes

  1. Myofibrillar protein synthesis

    Time frame: 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

  2. Pattern of change in plasma total amino acid, essential amino acid and leucine concentrations

    Time frame: 6 months

    Assessed via GC-MS.

Secondary outcomes

  1. Changes in microbiome composition

    Time frame: 6 months

    Assessed in faecal samples via 16s rRNA analysis

  2. Change in metabolome

    Time frame: 6 months

    Assesed in blood and faecal water via 600 MHz nuclear magnetic resonance (NMR) spectrometry

  3. Changes in gut hormones

    Time frame: 6 months

    ELISA (enzyme-linked immunosorbent assay)

  4. Changes in gut/digestion-related complaints

    Time frame: 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).

  5. Changes in bowel movement

    Time frame: 6 months

    Assessed via the Bristol Stool chart, where average faecal appearance is indicated out of seven options available

  6. Changes in strength

    Time frame: 6 months

    Assessed via handgrip strength using a handgrip dynamometer

  7. Changes in immuno-surveillance

    Time frame: 6 months

    Assessed via the Common Cold Questonnaire (CCQ), where minimum and maximum values are: none, and severe respectively (higher score means worse outcome).

  8. Changes in appetite

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University College Dublin

Other

Collaborators

  • Kerry Group

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Mar 5, 2020
Registry last updated
Nov 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.