Probiotic-Muscle Study

NCT04297111 | Completed DMC

• 1 other identifier: IRCEB
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

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

  Assessed via GC-MS.

  6 months

Secondary Outcomes (8)

• Changes in microbiome composition

  6 months

• Change in metabolome

  6 months

• Changes in gut hormones

  6 months

• Changes in gut/digestion-related complaints

  6 months

• Changes in bowel movement

  6 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Maltodextrin containing capsule

Other: Placebo

Probiotic

EXPERIMENTAL

Probiotic containing capsule

Dietary Supplement: Probiotic

Interventions

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.

Probiotic

Placebo OTHER

Maltodextrin capsule, no active ingredient

Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University College Dublin: lead
• Kerry Group: collaborator

Study Sites (1)

University College Dublin

Dublin, Ireland

Location

MeSH Terms

Conditions

Frailty; Muscle Weakness

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Helen Roche, PhD

  University College Dublin

  PRINCIPAL INVESTIGATOR

• Caoielann Murphy, PhD

  University College Dublin

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Helen Roche

Model Details: 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.

Study Record Dates

• First Submitted: March 3, 2020
• First Posted: March 5, 2020
• Study Start: November 25, 2019
• Primary Completion: October 3, 2020
• Study Completion: December 1, 2021
• Last Updated: November 3, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)