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Clinical Trial Details

Trial ID: L1726
Source ID: NCT02568020
Associated Drug: Keto-Amino Acids
Title: LPD+α-ketoacids on Autophagy and Improving Muscle Wasting in CKD
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Muscular Atrophy
Interventions: DRUG: keto-amino acids
Outcome Measures: Primary: Body weight assessment, the parameters of skeletal muscle will be assessed before and after dietary intervention for 12 months. Body weight will be measured to calculate Body mass index., 1 year|skeletal muscle mass, the parameters of skeletal muscle will be assessed before and after dietary intervention for 12 months. muscle circumference including mid-arm, mid-thigh, and mid-calf circumferences will be assessed., 1 year|Quadriceps strength assessment, the parameters of skeletal muscle will be assessed before and after dietary intervention for 12 months. Quadriceps strength will be assessed with a seated leg press exercise instrument (Keiser Sport, Fresno, CA, USA) using the five repetition maximum technique., 1 year|Knee and hip extension power assessment, the parameters of skeletal muscle will be assessed before and after dietary intervention for 12 months. Knee and hip extension power (rate of generating force) will be assessed with a validated leg power instrument (University ofNottingham Medical College, Nottingham, UK)., 1 year|Fatigability assessment, the parameters of skeletal muscle will be assessed before and after dietary intervention for 12 months. Fatigability will be assessed with the same leg power instrument (University ofNottingham Medical College, Nottingham, UK) as used in strength testing., 1 year|Height assessment, the parameters of skeletal muscle will be assessed before and after dietary intervention for 12 months. Height will be measured to calculate Body mass index, 1 year | Secondary: Dietary assessment, The composition of the diet will be evaluated through questionnaire, 1 year|computer-based nutritional assessment, analyzed a computer-based nutritional evaluation with Dieta software., 1 year|Biochemical data, blood samples will be collected at baseline and every 3 months of routine examination, such as blood routine, biochemistry, HbA1c, Serum IGF-1, CRP, will be measured., 1 year|calculate HOMA-IR, Homeostatic model assessment score (HOMA-IR) was recorded., 1 year|Safety parameters, Blood routine:including WBC, RBC, Hb, PLT, HCT; Blood biochemistry:including Ca, P, iPTH, albumin, prealbumin, transferrin, creatinine, Bun,CRP Blood fat: cholesterol, triglyceride(VLDL、LDL、HDL), 1 year
Sponsor/Collaborators: Sponsor: YUAN Wei-jie
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 60
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2016-11
Completion Date: 2019-05
Results First Posted:
Last Update Posted: 2016-11-01
Locations:
URL: https://clinicaltrials.gov/show/NCT02568020