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A clinical study for evaluating the safety of excessive intake of amino acid mixture in a double-blind, placebo-controlled study.

A clinical study for evaluating the safety of excessive intake of amino acid mixture in a double-blind, placebo-controlled study. - A clinical study for evaluating the safety of excessive intake of amino acid mixture.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000024506
Enrollment
30
Registered
2016-10-23
Start date
2016-10-24
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

placebo intake test food intake

Sponsors

KSO Corporation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Adults 20 to 65 years age 2) Subjects whose BMI of 18.5 to 30 kg/m^2 3) Subjects giving written informed consent

Exclusion criteria

Exclusion criteria: 1) Subjects who regularly use medication affecting obesity, hyperlipidemia, lipid metabolism. 2) Subjects who cantract serious diseases (e.g., liver disease, heart disease, respiratory disease, endocrine disease, metabolic disorder, food allergic disease.) 3) Subjects who can't stop using supplements and/or functional foods affecting obesity, hyperlipidemia, lipid metabolism. 4) Subjects whoare under treatment for or have a history of drug addication and/or alcoholism. 5) Subjects who can't stop drinking from 2 days before each inspection date. 6) Subjects who have medical history of deseases or surgeries which affect digestion and absorption. 7) Phenylketonuria, and hyperphenylalaninemia 8) Subjects who have been diagnosed with familial hyperlipidemia 9) Subjects who are pregnant or nursing, or who wish to become pregnant during the study. 10) Subjects whose eating habits are extremely irregulae (ex. midnight and irregulae shift worker) 11) Subjects who are planning to participate in other clinical studies. 12) Subjects who are judged as unsuitable for the study by the investigator for other reason.

Design outcomes

Primary

MeasureTime frame
Hematologic test Biochemistry test Urinalysis Blood pressure/pulse Weight/body mass index Medical interview Adverse event

Countries

Japan

Contacts

Public ContactEiji Yoshikawa

KSO Corporation Sales department

yoshikawa@kso.co.jp03-3452-7733

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026