A Study of Branched Chain Amino Acid Intake in Diabetes Mellitus

JRCT ID: jRCT1051240105

Registered date:07/08/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Diabetes Melitus
• Date of first enrollment: 07/08/2024
• Target sample size: 20
• Study type: Interventional
• 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 Outcome: Changes in body composition
• Secondary Outcome: Nutritional 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 maximum: Not applicable
• Gender: Both

Include criteria

Patients 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 criteria

Exclusion 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

• Primary Sponsor: Fukui Michiaki
• Source(s) of Monetary Support: Cosmic Corporation CO.