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Probiotic-Muscle Study

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University College Dublin

Status

Completed

Conditions

Protein Deregulation
Protein Deposition
Muscle Weakness
Old Age; Debility

Treatments

Other: Placebo
Dietary Supplement: Probiotic

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 patients

Sex

All

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

12 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Maltodextrin containing capsule
Treatment:
Other: Placebo
Probiotic
Experimental group
Description:
Probiotic containing capsule
Treatment:
Dietary Supplement: Probiotic

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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