Investigating the effects of synbiotic supplementation on functional movement, strength and muscle health in older Australians

Not Applicable

Recruiting

• Conditions: sarcopenia; Diet and Nutrition - Other diet and nutrition disorders; Alternative and Complementary Medicine - Other alternative and complementary medicine; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12622000652774
• Lead Sponsor: Swinburne University of Technology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-03
• Last Update Posted: 30 January 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 74

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the effectiveness of a multi-strain synbiotic formulation on indicators of functional performance: <br>Within group and between group effect in 4-meter gait speed. <br><br><br>[Baseline, 8 weeks, 16 weeks (primary timepoint) and 20 weeks following commencement of intervention];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). [Baseline, 8 weeks, 16 weeks (primary timepoint) and 20 weeks following commencement of intervention.];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.[Baseline, 8 weeks, 16 weeks (primary timepoint) and 20 weeks following commencement of intervention.]