AJI-2022VLIT-S1

JRCT ID: jRCT1050230137

Registered date:25/11/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Health Conditions
• Date of first enrollment: 25/11/2023
• Target sample size: 120
• Study type: Interventional
• Intervention(s): Each of the four amino acids will be randomly assigned to one of the four Dose groups and ingested for four weeks. The intervention period of the study intake will be one term, and each subject will be assigned four times.

Outcome(s)

• Primary Outcome: For each amino acid evaluated in this study, laboratory values at each intake dose will be evaluated in comparison to placebo.
• Secondary Outcome: For each amino acid evaluated in this study, the number of adverse events (excluding laboratory tests) at each intake dose will be evaluated in comparison to placebo.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 60age old
• Gender: Male

Include criteria

1) Healthy male aged between 20 and 60 years at the time of informed consent.
2) Subjects who have fully understood the purpose and content of this research after receiving a sufficient explanation about participating in the research, and who have given their voluntary written consent.

Exclude criteria

1) Are taking or are likely to take pharmaceuticals on an ongoing basis during the period of consumption of the test food.
2) Is taking or will take a supplement containing amino acids as a major component from the time of study entry until the end of the test food intake period.
3) Are currently participating in another human study as a study subject, have participated in another human study within 4 weeks of the completion of the study, or plan to participate in another human study during the study period.
4) Any of the following
(1) Persons with heart, liver, or kidney disease (including complications from other diseases)
(2) Persons with respiratory system diseases
(3) Those with a history of cardiovascular disease
(4) Those who have diabetes mellitus
(5) Those who have intestinal disease
(6) Those who have heavy burden of cancer, tuberculosis, etc.Those who are under treatment for or have a history of serious diseases such as cancer and tuberculosis
(7) Those with congenital metabolic disorders of branched-chain amino acids
5) Subjects with allergies to medicinal products or food
6) Other subjects who are judged by the investigator to be unsuitable for the study

Related Information

• Primary Sponsor: Miura Naoki
• Secondary Sponsor: AJINOMOTO CO., INC.