Probiotic-Muscle Study

NCT ID: NCT04297111

Last Updated: 2022-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-25
• Study Completion Date: 2021-12-01

Brief 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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Maltodextrin containing capsule

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Maltodextrin capsule, no active ingredient

Probiotic

Probiotic containing capsule

Group Type: EXPERIMENTAL

Probiotic

Intervention Type: 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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Maltodextrin capsule, no active ingredient

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kerry Group

UNKNOWN

Sponsor Role: collaborator

University College Dublin

OTHER

Sponsor Role: lead

Responsible Party

Prof Helen M Roche

Professor Helen Roche

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Helen Roche, PhD

Role: PRINCIPAL_INVESTIGATOR

University College Dublin

Caoielann Murphy, PhD

Role: STUDY_DIRECTOR

University College Dublin

Locations

University College Dublin

Dublin, , Ireland

Countries

Ireland

Other Identifiers

IRCEB

Identifier Type: -

Identifier Source: org_study_id