A clinical study for evaluating the safety of excessive intake of amino acid mixture in a double-blind, placebo-controlled study.
- Conditions
- o
- Registration Number
- JPRN-UMIN000024506
- Lead Sponsor
- KSO Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hematologic test Biochemistry test Urinalysis Blood pressure/pulse Weight/body mass index Medical interview Adverse event
- Secondary Outcome Measures
Name Time Method