None listed
Conditions
Brief summary
This will be a randomized, placebo-controlled, double-blinded study to evaluate the effects of a multi-strain synbiotic formulation on measures of physical performance, strength and muscle health in older populations. The study aims to investigate the effects of a multi-strain synbiotic supplement on muscle strength, mass and quality and functional performance in older individuals. Approximately 74 male and female participants aged between 60 - 85 will be randomized to receive in a double-blinded fashion either a synbiotic (Pro- + Pre-biotic) or placebo for 16 weeks. Participants will complete 5 visits: Screening (day-14), Baseline (day 1), mid-intervention (week 8), end of intervention (week 16), and a follow-up visit at 20 weeks. Participants will complete a range of tests at each visit that will assess muscle grip strength and functional performance (Short Physical Performance Battery), body composition and muscle quality (Dual X-Ray Absorptiometry and ultrasonography) and self-reported indicators on quality of life, mood and sleep quality via questionnaire. Blood and fecal samples will be collected from participants at each visit to assess clinical blood chemistry and gut microbiota composition. The expected outcomes are that 16 weeks of daily synbiotic supplementation will result in statistically greater 1) improvements in muscle strength, functional performance and muscle quality and 2) increases in microbial diversity compared to placebo.
Interventions
Participants will receive oral multi-strain synbiotic formulation or placebo (in the form of a sachet containing powder to be dissolved in water and consumed as a drink) daily for 16 weeks.
IP will be a newly developed formulation consisting of 3 strains of common probiotics and 1 prebiotic from Lallemand Health Solutions. Dose falls within the range of 1 to 100 billion CFU probiotic, 500 to 1000 mg of prebiotic, and the exact doses will be disclosed after IP restrictions are met.
Adherence to
Participants will receive oral multi-strain synbiotic formulation or placebo (in the form of a sachet containing powder to be dissolved in water and consumed as a drink) daily for 16 weeks. IP will be a newly developed formulation consisting of 3 strains of common probiotics and 1 prebiotic from Lallemand Health Solutions. Dose falls within the range of 1 to 100 billion CFU probiotic, 500 to 1000 mg of prebiotic, and the exact doses will be disclosed after IP restrictions are met. Adherence to study IP will be determined by collecting returned IP and calculating compliance: (quantity dispensed – returned) / (total dosing days) x 100 = % compliance
Sponsors
Swinburne University of Technology
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
60 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
1. Evidence of a personally signed and dated informed consent form (ICF) indicating that the subject has been informed of all pertinent aspects of the study. 2. Healthy adults* who are determined by medical history and clinical judgment of the investigator to be eligible for inclusion in the study. *Note: Healthy subjects with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease within 6 weeks before enrolment, can be included. 3. Male and female adults between ages of 60 and 85 years of age (inclusive) at the time of enrolment (signing of the ICF). 4. Willing and able to comply with scheduled visits, laboratory tests, and other study procedures. 5. Willing to refrain from consuming probiotic supplements and food containing added probiotics and/or prebiotics (e.g., yoghurts with live, active cultures or supplements) from screening until the end of the study (week 20). 6. Able to walk 10 meters. 7. Able to get up from a chair. 8. BMI between 18 and 30 (inclusive) and body weight of at least 40 kgs.
Exclusion criteria
1. Use of probiotics, prebiotics or antibiotics in the past 4 weeks (screened participants that are otherwise eligible may enrol into the study after a 4-week wash-out period). 2. Use of proton pump inhibitors in the last 3 months. 3. Chronic treatment with statins or other drugs with known myotoxicity. 4. Musculoskeletal or other disorder resulting in inability to perform physical function testing. 5. Presence of medical conditions causing secondary sarcopenia (i.e., stroke, osteoarthritis or other rheumatic diseases). 6. Presence of diseases or disorders that can impact muscle mass (i.e., cancer, CKD, chronic fatigue, etc.). 7. At risk for malnutrition (MNA-SF less than or equal to 7). 8. Milk or soy allergy.
Outcome results
None listed