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JAPANESE
国立保健医療科学院
JRCT ID: jRCT1051240105

Registered date:07/08/2024

A Study of Branched Chain Amino Acid Intake in Diabetes Mellitus

Basic Information

Recruitment status Pending
Health condition(s) or Problem(s) studiedDiabetes Melitus
Date of first enrollment07/08/2024
Target sample size20
Countries of recruitment
Study typeInterventional
Intervention(s)Participants will be provided with 1 kg of BCAA powder. After returning home, they are instructed to measure 10g per day with a scale and dissolve it in 350~450ml of water using a bottle.

Outcome(s)

Primary OutcomeChanges in body composition
Secondary OutcomeNutritional status (cholinesterase, fasting blood glucose, HbA1c, urinary albumin), inflammatory status (high sensitivity CRP), grip strength, physical findings (blood pressure)

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteriaPatients participating in this study must meet all of the following criteria 1.Participants in the previous study, Cohort Study of Patients with diabetes (Decision Notice No.: RBMR-E-466). 2.Patients who wish to take branched-chain amino acids (BCAA) as an oral dietary supplement to counteract sarcopenia/frailty associated with diabetes mellitus and who will start taking BCAA powder. 3.Patients in the first or second stage of diabetic nephropathy 4.Patients who are able to obtain written consent for participation in the study from themselves of their own free will. 5.Age: 20 years and older
Exclude criteriaExclusion criteria 1.Women who are pregnant or may become pregnant 2.Patients with a history of anemia or undergoing treatment 3.Patients with congenital abnormality of branched-chain amino acid metabolism 4.Patients who are deemed inappropriate by the attending physician.

Related Information

Contact

Public contact
Name Masahide Hamaguchi
Address 465, Kajii-cho, Kawaramachi-Dori, Hirokoji-Agaru Kyoto Japan 602-8566
Telephone +81-752515506
E-mail mhama@koto.kpu-m.ac.jp
Affiliation Kyoto Prefectural University of Medicine
Scientific contact
Name Michiaki Fukui
Address 465, Kajii-cho, Kawaramachi-Dori, Hirokoji-Agaru Kyoto Japan 602-8566
Telephone +81-752515506
E-mail mhama@koto.kpu-m.ac.jp
Affiliation Kyoto Prefectural University of Medicine