臨床研究等提出・公開システム

Japanese

Date of registration	April. 02, 2026
Last modified on	April. 02, 2026
Trial ID	jRCT1050260004

Scientific Title	An Exploratory, Randomized, Double-Blind, Parallel-Group Controlled Trial to Evaluate the Safety of L-Aspartate Sodium and L-Cystine Intake in Healthy Adults (AJI-2026AC)
Public Title	An Exploratory, Randomized, Double-Blind, Parallel-Group Controlled Trial to Evaluate the Safety of L-Aspartate Sodium and L-Cystine Intake in Healthy Adults

Contact for Scientific Queries	Name	Miura Naoki
	Affiliation	Miura Clinic, Medical Corporation Kanonkai
	Address	Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka
	Telephone	+81-6-6135-5200
	E-mail	k.miura.cl@gmail.com
Contact for Public Queries	Name	Terashima Makoto
	Affiliation	Oneness Support Co., Ltd.
	Address	Higashitenma building 4F, 1-7-17, Higashitenma, Kita-ku, Osaka
	Telephone	+81-6-4801-8917
	E-mail	mterashima@oneness-sup.co.jp

Recruitment status	Pending

Anticipated date of first enrollment		April. 02, 2026
Actual date of first enrollment		May. 11, 2026
Target sample size		200
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	1) Healthy male subjects aged >=20 and <60 years at the time of informed consent 2) Subjects who have received a full explanation of the study, have fully understood its purpose and procedures, and have provided written informed consent of their own free will
	Exclusion Criteria	1) Subjects who are continuously taking medications during the intake period of the test food, or who are expected to take such medications 2) Subjects who are currently taking, or plan to take, supplements containing amino acids as the main component from the time of study participation until the end of the test food intake period 3) Subjects who are currently participating in another clinical study, who have participated in another study within 4 weeks prior to enrollment, or who plan to participate in another study during the study period 4) Subjects who meet any of the following criteria: 1 Subjects with diseases of the heart, liver, or kidneys (including those secondary to other diseases) 2 Subjects with respiratory diseases 3 Subjects with a history of cardiovascular disease 4 Subjects with diabetes mellitus 5 Subjects with gastrointestinal diseases 6 Subjects who are currently undergoing treatment for, or have a history of, serious diseases such as cancer or tuberculosis 5) Subjects with allergies to medications or foods 6) Subjects who are otherwise considered inappropriate for participation in the study by the principal investigator
	Age Minimum	20age old over
	Age Maximum	60age old not
	Gender	Male
Health Condition(s) or Problem(s) Studied		Healthy adults
Intervention(s)		L-Aspartate Sodium Monohydrate will be administered orally at doses of 0 g/day (placebo), 4 g/day, 6 g/day, 8 g/day, or 10 g/day for 12 weeks. L-Cystine will be administered orally at doses of 0 g/day (placebo), 3 g/day, 4 g/day, 5 g/day, or 6 g/day for 12 weeks.
Health Condition(s) Keyword		Healthy adults
Health Condition(s) Code		D064806
Primary Outcome(s)		Comparison of clinical laboratory values at each dose level of amino acid intake with those in the placebo group.
Secondary Outcome(s)		Comparison of the incidence of adverse events at each dose level for each amino acid with those in the placebo group.

Primary Sponsor	AJINOMOTO CO., INC.

Secondary Sponsor	Not applicable

Secondary Sponsor

Name of Certified Review Board	Miura Clinic, Medical Corporation Kanonkai IRB
Address	Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka, Osaka, Osaka
Telephone	+81-6-6135-5200
E-Mail	info@miura-cl.jp
Approval Status	Approval
Date of approval	Mar. 30, 2026

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none