Old Age; DebilityNCT04297111
Probiotic-Muscle Study
A study testing Probiotic in people with Old Age; Debility and Muscle Weakness, run by University College Dublin at 1 site in Ireland.
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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Old Age; Debility, Muscle Weakness, Protein Deregulation
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteIreland
- Study dates
- 25 Nov 2019to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Probiotic, Placebo
- Medical subject headings
- Frailty, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary 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.
PlaceboOther
Maltodextrin capsule, no active ingredient
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Maltodextrin containing capsule Receives: Other: Placebo |
| Probiotic | Experimental | Probiotic containing capsule Receives: Dietary Supplement: Probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Pattern of change in plasma total amino acid, essential amino acid and leucine concentrations
Assessed via GC-MS.
Measured: 6 months
Secondary outcomes (8)
Changes in microbiome composition
Assessed in faecal samples via 16s rRNA analysis
Measured: 6 months
Change in metabolome
Assesed in blood and faecal water via 600 MHz nuclear magnetic resonance (NMR) spectrometry
Measured: 6 months
Changes in gut hormones
ELISA (enzyme-linked immunosorbent assay)
Measured: 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).
Measured: 6 months
Changes in bowel movement
Assessed via the Bristol Stool chart, where average faecal appearance is indicated out of seven options available
Measured: 6 months
Changes in strength
Assessed via handgrip strength using a handgrip dynamometer
Measured: 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).
Measured: 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)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start25 Nov 2019
- Primary completion3 Oct 2020
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Old Age; DebilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Collaborators
- Kerry Group
- Responsible party
- Principal investigator, Prof Helen M Roche, University College Dublin
- Investigators
- Helen Roche, PhD, Principal investigator, University College DublinCaoielann Murphy, PhD, Study director, University College Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04297111
- Sponsor's protocol ID
- IRCEB
- Status last verified
- Nov 2022
- First submitted
- 3 Mar 2020
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Research results will be published in a peer-reviewed journal once the study has finalised and the data has been analized.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bacillus Coagulans on Skeletal Muscle Protein Synthesis in Response to Vegetable Protein Ingestion
- ClinicalTrials.gov ID
- NCT04297111
- Acronym / sponsor ID
- IRCEB
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Collaborators
- Kerry Group
- Study start
- 25 Nov 2019 (actual)
- Primary completion
- 3 Oct 2020 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 5 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboMaltodextrin containing capsule |
| Probiotic | Experimental | Dietary Supplement: ProbioticProbiotic containing capsule |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- Cancer (malignancy in the past 5 years)
- CVD
- Chronic kidney disease
- Liver failure
- Diabetes or pre-diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticGanedenBC30 (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. | Dietary supplement | Probiotic |
| PlaceboMaltodextrin capsule, no active ingredient | Other | Placebo |
Primary outcome
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
Pattern of change in plasma total amino acid, essential amino acid and leucine concentrations
Time frame: 6 months
Assessed via GC-MS.
8 secondary outcomes
Changes in microbiome composition
Time frame: 6 months
Change in metabolome
Time frame: 6 months
Changes in gut hormones
Time frame: 6 months
Changes in gut/digestion-related complaints
Time frame: 6 months
Changes in bowel movement
Time frame: 6 months
Changes in strength
Time frame: 6 months
Changes in immuno-surveillance
Time frame: 6 months
Changes in appetite
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Individual participant dataSharing planned: No. Research results will be published in a peer-reviewed journal once the study has finalised and the data has been analized.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helen Roche, PhD principal investigator
University College Dublin
Caoielann Murphy, PhD study director
University College Dublin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Old Age; Debility and Muscle Weakness, run by University College Dublin at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myofibrillar protein synthesis (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.