Study for confirming anti-obesity effect by ingesting test food (preliminary examination)
- Conditions
- Healthy male
- Registration Number
- JPRN-UMIN000037428
- Lead Sponsor
- CPCC CO., LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 40
Not provided
(1) Subjects who are given continuous treatment by taking medicines. (2) Subjects who having Food for Specified Health Uses (FOSHU), functional food, health food and/or supplements having a possibility of affecting test results. (3) Subjects who have weak digestive organ. Especially subjects who may feel discomfort for example stomach astigmatism after intake of drinks containing tannin like strong green tea, black tea and coffee. (4) Subjects who are severe anemia, or who have been diagnosed with severe anemia by the doctor (5) Subjects who have previous and/or current medical history of serious disease (e.g., heart, liver, kidney, digestive organ). (6) Subjects who excessive alcohol intake. (7) Subjects who have extremely irregular dining habits, and subjects who have midnight work or irregular shift work. (8) Subjects who have previous medical history of drug and/or food allergy. (9) Subjects who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests. (10) Subjects who donated over 200mL blood and/or blood components within the last one month to the current study. (11) Subjects who donated over 400mL blood and/or blood components within the last three month to the current study. (12) Subjects who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study. (13) Others who have been determined ineligible by principal investigator or sub-investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Body weight BMI Body fat percentage Visceral fat area
- Secondary Outcome Measures
Name Time Method Amount of liver fat Fatty liver Waist circumference Incidence of adverse events and/or side effects