CompletedNot Applicable

Probiotic-Muscle Study

Ireland12 participantsStarted 2019-11-25

Plain-language 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.

Who can participate

Age range

65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Myofibrillar protein synthesis

Timeframe: 6 months

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

Timeframe: 6 months

Trial details

NCT IDNCT04297111

SponsorUniversity College Dublin

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-10-03

View on ClinicalTrials.gov More Old Age; Debility trials