Authors
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[No authors listed]
Category
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Primary study
Registry of Trials»Japan Primary Registry Network
Year
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2020
INTERVENTION: By half is randomly assigned in one of the Biffidobacterium group or the placebo groups and takes in each examination food for 24 weeks CONDITION: Sarcopenia ; Sarcopenia Intestinal bacteria PRIMARY OUTCOME: the amount of change in intake 24 weeks from a baseline of the knee extension muscular strength SECONDARY OUTCOME: (1)Evaluation of the body composition; (the DXA method) a skeletal muscle mass index: It is a rate of change, the amount of change in intake 24 weeks from SMI (Skeletal Muscle Mass Index) (kg/m2), a baseline of the SMI; (the DEXA method) is a rate of change, the amount of change in intake 24 weeks from limbs skeletal muscle mass (kg), the baseline of the limbs skeletal muscle mass; (the DEXA method) is a rate of change, the amount of change in intake 24 weeks from quantity of non‐fat (kg), a baseline of the quantity of non‐fat; (the DEXA method) is a rate of change, the amount of change in intake 24 weeks from lumbar vertebrae, a thighbone neck (BMD, YAM(%), T‐score, Z‐score), the baseline of lumbar vertebrae, the thighbone neck (BMD, YAM(%), T‐score, Z‐score); (the BIA method) a skeletal muscle mass index: It is a rate of change, the amount of change in intake 12 weeks, 24 weeks from SMI (Skeletal Muscle Mass Index) (kg/m2), a baseline of the SMI; (the BIA method) is a rate of change, the amount of change in intake 12 weeks, 24 weeks from limbs skeletal muscle mass (kg), the baseline of the limbs skeletal muscle mass; (the BIA method) is a rate of change, the amount of change in intake 12 weeks, 24 weeks from a phase angle, the baseline of the phase angle; (2)Evaluation of the muscular strength; It is the rate of change in intake 24 weeks from knee extension muscular strength, a baseline of the knee extension muscular strength; It is a rate of change, the amount of change in intake 12 weeks, 24 weeks from grip (kg), the baseline of the grip; It is a rate of change, the amount of change in intake 12 weeks, 24 weeks from temporarily physical ability battery (Short Physical Performance Battery: SPPB), a baseline of SPPB; (3)Evaluation of the body function; It is usually a rate of change, the amount of change in intake 12 weeks, 24 weeks from a walking speed, the baseline of the normal walking speed; (4)I extract DNA from enterobacterial flora analysis, the feces before and after a change, a rate of change, the amount of change intake after intake 24 weeks ago of the enterobacterial flora analysis and carry out enterobacterial flora analysis by 16SrDNA sequensing. Specifically, I perform comparison of the enterobacterial flora, variety analysis, the main coordinate analysis, LEfSe analysis.; (5)Interview vote; It is a rate of change, the amount of change in intake 12 weeks, 24 weeks from Izumo scale (countercurrent, stomachache, heavy stomach, constipation, diarrhea), the baseline of the Izumo scale; It is a rate of change, the amount of change in 24 weeks from a rate of change, amount of change DVS in intake 12 weeks, 24 weeks, a baseline of DVS from a screening interview vote of rate of change, the amount of change in 24 weeks from a rate of change, amount of change EAT‐10 (deglutition screening tool) in intake 12 weeks, 24 weeks, a baseline of EAT‐10 from a screening interview vote of rate of change, amount of change oral frailty in intake 12 weeks, 24 weeks, the baseline of the screening interview vote of oral frailty from constipation scoring system (CSS), a baseline of the CSS for intake 12 weeks; (6)Oral cavity function evaluation; It is a rate of change, the amount of change in intake 12 weeks, 24 weeks from tongue pressure, a baseline of the tongue pressure; It is a rate of change, the amount of change in intake 12 weeks, 24 weeks from bite pressure, a baseline of the bite pressure; It is a rate of change, the amount of change in intake 12 weeks, 24 weeks from having periodontal disease or not, a baseline of having periodontal disease or not; It is a rate of change, the amount of change in 24 weeks from a rate of change, the amount of change denture (3 classifications of dentureless partial dentures, full dentures) in intake 12 weeks, 24 weeks, the baseline of the denture (3 classifications of dentureless partial dentures, full dentures) from the residual number of the teeth, intraoral dental formula confirmation (sound tooth, measures tooth, naive tooth, the number of the lost teeth), the residual number of the teeth, a baseline of the intraoral dental formula confirmation (sound tooth, measures tooth, naive tooth, the number of the lost teeth) for intake 12 weeks INCLUSION CRITERIA: (1)The age at agreement acquisition is man and woman younger than 90 years 50 years old or older (2)1 or 2 or both concretely following correspond and the patient whom sarcopenia was diagnosed in by the sarcopenia diagnosis that Asian Working Group for Sarcopenia proposes correspond to 3 AWGS 2019 1.A grip drop Male <28kg, woman <18kg 2.A walking speed drop <1.0 m/sec 3.By the measurement of the quantity of muscle the drop (male <7.0 kg/m2, woman <5.4 kg/m2) of the skeletal muscle mass index (SMI) by the DXA method (3)Written informed consent is provided about the participation in this study.
Epistemonikos ID: 99323d1dbd306a00136e70fba3c258b6fd3c1260
First added on: Aug 24, 2024