A Study on the Effect of Food Containing Plant Extract on Liver Function -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study
- Conditions
- o
- Registration Number
- JPRN-UMIN000047438
- Lead Sponsor
- KSO Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 60
Not provided
(1)Subjects who regularly use medications. (2) Subjects who contract or are under treatment for serious diseases (e.g., liver disease, cardiovascular disease, respiratory disease, endocrine disease and/or metabolic disease). (3)Subjects who have a history and/or a surgical history of digestive disease affecting digestion and absorption. (4) Subjects who have a history of and/or contract drug addiction and/or alcoholism. (5)Subjects who have excessive alcohol intake more than approximately 60 g/day of pure alcohol equivalent or habit of drinking not less than 5 days a week. (6)Subjects who can't stop using supplements and/or functional foods (including Foods with Function Claims) during test periods. (7)Subjects who can't stop drinking from 2 days before each measurement. (8)Subjects who have declared allergic reaction to ingredients of test foods. (9)Subjects who are shiftworker and/or midnight-shift worker. (10)Subjects with extremely irregular dietary habits. (11)Subjects who plan to travel abroad, including overseas travel, during test periods. (12)Subjects who have been pregnant or have a plan to become pregnant, or breast feed during the study period. (13)Subjects who have donated over 200 mL of blood and/or blood components within the last 4 weeks prior to the current study or over 400 mL of blood and/or blood components within the last three months prior to the current study. (14)Subjects who are planning to participate and/or had participated in other clinical studies within the last one month prior to the current study. (15)Subjects who are judged as unsuitable for the current study by the investigator for other reasons.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method iver function enzyme
- Secondary Outcome Measures
Name Time Method Questionnaire survey (Visual Analogue Scale)