ACTRN12622000652774Recruiting未知
Investigating the effects of synbiotic supplementation on functional movement, strength and muscle health in older Australians
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Recruiting
- Enrollment
- 74
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 60 Years to 85 Years (—)
- Sex
- All
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.
Investigators
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