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

Swinburne University of Technology0 个研究点目标入组 74 人开始时间: 2022年5月3日最近更新: 2023年1月30日

适应症

试验速览

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•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.

•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.

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