Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000652774
Ethics application status
Approved
Date submitted
18/04/2022
Date registered
3/05/2022
Date last updated
25/01/2023
Date data sharing statement initially provided
3/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the effects of synbiotic supplementation on functional movement, strength and muscle health in older Australians
Scientific title
Investigating the effects of synbiotic supplementation on functional movement, strength and muscle health in older Australians
Secondary ID [1] 306954 0
SB1001
(Protocol Number- Swinburne University of Technology)
Universal Trial Number (UTN)
U1111-1277-2798
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sarcopenia 326070 0
Condition category
Condition code
Diet and Nutrition 323378 323378 0 0
Other diet and nutrition disorders
Alternative and Complementary Medicine 323379 323379 0 0
Other alternative and complementary medicine
Musculoskeletal 323380 323380 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 323400 0
Treatment: Other
Comparator / control treatment
placebo (maltodextrin)
Control group
Placebo

Outcomes
Primary outcome [1] 331114 0
To determine the effectiveness of a multi-strain synbiotic formulation on indicators of functional performance:
Within group and between group effect in 4-meter gait speed.


Timepoint [1] 331114 0
Baseline, 8 weeks, 16 weeks (primary timepoint) and 20 weeks following commencement of intervention
Primary outcome [2] 331115 0
To determine the effectiveness of a multi-strain synbiotic formulation on balance: within group and between group effect in balance (side-by-side, semi-tandem, tandem and one-foot).
Timepoint [2] 331115 0
Baseline, 8 weeks, 16 weeks (primary timepoint) and 20 weeks following commencement of intervention.
Primary outcome [3] 331116 0
To determine the effectiveness of a multi-strain synbiotic formulation on muscle strength: within group and between group effect in handgrip strength via handheld dynamometer.
Timepoint [3] 331116 0
Baseline, 8 weeks, 16 weeks (primary timepoint) and 20 weeks following commencement of intervention.
Secondary outcome [1] 408802 0
To determine the effectiveness of a multi-strain synbiotic formulation on muscle mass and quality:
Within group and between group effect in bone density and body composition will be assessed as a composite of [lean body mass (LBM), appendicular lean mass (ALM), total and regional body fat mass (FM) and fat-free mass (FFM)] as determined via Dual-energy X-ray Absorptiometry (DXA).
Timepoint [1] 408802 0
Baseline, 8 weeks, 16 weeks and 20 weeks following commencement of intervention.
Secondary outcome [2] 408803 0
To determine the effectiveness of a multi-strain synbiotic formulation on gut microbiota composition and diversity and their associated metabolites: 1) within group and between group effect in fecal microbiota composition, diversity and probiotic strain recovery. 2) within group and between group effect in untargeted and/or targeted fecal and plasma metabolomics.
Timepoint [2] 408803 0
Baseline, 8 weeks, 16 weeks and 20 weeks following commencement of intervention.
Secondary outcome [3] 408804 0
To determine the effectiveness of a multi-strain synbiotic formulation on self-reported indicators of sarcopenia: within group and between group effect in SARC-F.
Timepoint [3] 408804 0
Baseline, 8 weeks, 16 weeks and 20 weeks following commencement of intervention.
Secondary outcome [4] 409049 0
Primary Outcome
To determine the effectiveness of a multi-strain synbiotic formulation on indicators of functional performance:
Within group and between group effect in repeat chair stands.
Timepoint [4] 409049 0
Baseline, 8 weeks, 16 weeks (primary timepoint) and 20 weeks following commencement of intervention.
Secondary outcome [5] 409050 0
Primary Outcome
To determine the effectiveness of a multi-strain synbiotic formulation on indicators of functional performance:
Within group and between group effect in timed up and go test.
Timepoint [5] 409050 0
Baseline, 8 weeks, 16 weeks (primary timepoint) and 20 weeks following commencement of intervention.
Secondary outcome [6] 409051 0
To determine the effectiveness of a multi-strain synbiotic formulation on muscle mass and quality:
Within group and between group effect in total LBM, cross-sectional area (CSA) and quality of quadriceps femoris muscle via ultrasonography.
Timepoint [6] 409051 0
Baseline, 8 weeks, 16 weeks and 20 weeks following commencement of intervention.
Secondary outcome [7] 409052 0
Safety Outcome
Changes (outside normal variation) in clinical hematology markers (Complete Blood Count [CBC] including hemaglobin, hematocrit, red blood cell indices, platelet count, leukocyte count and differential elicited after baseline and through week 16.
Timepoint [7] 409052 0
Baseline, 8 weeks and 16 weeks following commencement of intervention.
Secondary outcome [8] 409053 0
Safety Outcome
Changes (outside normal variation) in clinical chemistry markers (Comprehensive Metabolic Panel [CMP] including glucose, calcium, albumin, protein, sodium, potassium, bicarbonate, chloride, blood urea nitrogen, creatinine, alkaline phosphatase, alanine amino transferase, aspartate amino transferase and bilirubin) elicited after baseline and through week 16.
Timepoint [8] 409053 0
Baseline, 8 weeks and 16 weeks following commencement of intervention.
Secondary outcome [9] 409054 0
Safety Outcome
Adverse events (AEs) elicited after baseline and through week 20.
Known/possible AEs may include minor gastrointestinal symptoms (abdominal cramping, nausea, soft stools, flatulence). These will be assessed via direct participant questioning and study-specific questionnaires: Gastrointestinal Symptom Rating Scale (GSRS) and Constipation Assessment Scale (CAS).
Timepoint [9] 409054 0
Baseline, 8 weeks, 16 weeks and 20 weeks following commencement of intervention.
Secondary outcome [10] 409055 0
Safety Outcome
Serious adverse events (SAEs) until study completion.
SAEs will be assessed via direct participant questioning. During their involvement in the study, participants will be asked to report any hospitalisations or medically-attended events to the study team. Medical records will be obtained and/or coordination with treating medical practitioners will be undertaken if and when necessary.
Timepoint [10] 409055 0
SAEs will be assessed at each study visit (Baseline, week 8, week 16 and week 20) and as per participant report until 20 weeks following commencement of intervention.

Eligibility
Key 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.
Minimum age
60 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
1) Numbered containers.
2) Allocation involved contacting the holder of the allocation schedule who was “off-site” or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
1) Stratified allocation.
2) Simple randomisation using a randomisation table created by computer software.

Stratification involved Short Physical Performance Battery (SPPB*) and handgrip strength (HGS) conducted during SCREENING (visit 1). *SPPB is a composite of Balance, Repeat Chair Stands and 4-m gait speed.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
The study will be a randomized, double-blinded, placebo-controlled, parallel group design. Approximately 74 eligible participants will be enrolled in the study to receive oral synbiotic formulation or placebo (n=37 per group) daily for 16 weeks. The study duration will be approximately 22 weeks. This will consist of a screening period of no greater than 2 weeks, a 16-week intervention period (including a mid-point at 8 weeks), and a 4-week follow-up period following intervention.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The estimated sample size for the main outcome measures of physical performance was based on an assumed correlation of 0.7 between the pre- and post-intervention outcome measures, and an effect size of Cohen’s d=1.2 for gait speed based on a recent study that examined the effects of a multi-strain probiotic on gait speed and the Timed Up and Go test. In order to have power of 80% and a significance level of 5%, our study anticipates an estimated sample size of 37 per group, taking into account a conservative ~30% dropout rate.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/11/2022
Actual
10/11/2022
Date of last participant enrolment
Anticipated
31/05/2023
Actual
Date of last data collection
Anticipated
31/10/2023
Actual
Sample size
Target
74
Accrual to date
23
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 37368 0
3122 - Hawthorn
Recruitment postcode(s) [2] 37370 0
3124 - Camberwell
Recruitment postcode(s) [3] 37371 0
3126 - Canterbury

Funding & Sponsors
Funding source category [1] 311272 0
University
Name [1] 311272 0
Swinburne University of Technology
Country [1] 311272 0
Australia
Funding source category [2] 311273 0
Commercial sector/Industry
Name [2] 311273 0
Lallemand Health Solutions
Country [2] 311273 0
Canada
Primary sponsor type
University
Name
Swinburne University of Technology
Address
35 Wakefield Street, Hawthorn VIC 3122
Country
Australia
Secondary sponsor category [1] 312632 0
None
Name [1] 312632 0
Address [1] 312632 0
Country [1] 312632 0
Other collaborator category [1] 282264 0
Commercial sector/Industry
Name [1] 282264 0
Lallemand Health Solutions
Address [1] 282264 0
6100 Royalmount ave
Montreal, QC, Canada H4P 2R2
Country [1] 282264 0
Canada

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310780 0
Swinburne University Human Research Ethics Committee
Ethics committee address [1] 310780 0
35 Wakefield Street, Hawthorn VIC 3122
Ethics committee country [1] 310780 0
Australia
Date submitted for ethics approval [1] 310780 0
04/03/2022
Approval date [1] 310780 0
29/04/2022
Ethics approval number [1] 310780 0
20226246-9780
Ethics committee name [2] 312303 0
Deakin University Human Research Ethics Committee
Ethics committee address [2] 312303 0
Melbourne Burwood Campus
221 Burwood Highway, Burwood, VIC 3125
Ethics committee country [2] 312303 0
Australia
Date submitted for ethics approval [2] 312303 0
27/10/2022
Approval date [2] 312303 0
27/10/2022
Ethics approval number [2] 312303 0
2022-296

Summary
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.
Trial website
https://www.swinburne.edu.au/research/centres-groups-clinics/centre-for-human-psychopharmacology/our-clinical-trials/synbiotic-supplementation-movement-strength-muscle-health-older-australians/
Trial related presentations / publications
Public notes
Newly developed formulation of 3 strains of common probiotics and 1 prebiotic from Lallemand Health Solutions.

Contacts
Principal investigator
Name 118838 0
A/Prof Matthew Cooke
Address 118838 0
Department of Health Science and Biostatistics
School of Health Sciences
Swinburne University of Technology
Mail no 21, PO Box 218, HAWTHORN, VIC, 3122
Country 118838 0
Australia
Phone 118838 0
+61 3 9214 5560
Fax 118838 0
Email 118838 0
mbcooke@swin.edu.au
Contact person for public queries
Name 118839 0
Dr David Barry
Address 118839 0
Department of Health Science and Biostatistics
School of Health Sciences
Swinburne University of Technology
Mail no 21, PO Box 218 HAWTHORN, VIC, 3122
Country 118839 0
Australia
Phone 118839 0
+61 468 364 576
Fax 118839 0
Email 118839 0
davidbarry@swin.edu.au
Contact person for scientific queries
Name 118840 0
Dr David Barry
Address 118840 0
Department of Health Science and Biostatistics
School of Health Sciences
Swinburne University of Technology
Mail no 21, PO Box 218 HAWTHORN, VIC, 3122
Country 118840 0
Australia
Phone 118840 0
+61 468 364 576
Fax 118840 0
Email 118840 0
davidbarry@swin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.