None
Conditions
Interventions
Ingestion of test food A for 4 consecutive weeks
Ingestion of test food B for 4 consecutive weeks
Ingestion of test food C for 4 consecutive weeks
Ingestion of test food D for 4 consecutive weeks
Sponsors
KANEKA CORPORATION
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Healthy males aged of 20-44 years 2) Subjects whose BMI18.5 kg/m2 <= and <25.0 kg/m2 3) Subjects who eat three meals a day(Subjects who are able to eat three meals a day during the intake period) 4) Subjects who can visit the clinic on the scheduled visit date 5) Subjects who agreed in writing with sufficient understanding of the purpose and contents of this study
Exclusion criteria
Exclusion criteria: 1) Subjects who have systolic blood pressure <90 mmHg 2) Subjects who donated their blood components and/or whole blood 200mL within the past 4 weeks 3) Subjects who participated in other clinical studies in the past 4 weeks or who are scheduled to participate in another study during the study period 4) Subjects who meet any of the following: a) suffering from heart, liver, or kidney disease (including complications of other diseases) b) having a history of cardiovascular disease c) diabetes d) allergic to the test food e) Subjects with a positive or suspected positive test for infectious diseases 5) Subjects who are under treatment at the time of obtaining consent to participate in the study 6) Subjects who have history of surgery on gastrointestinal part such as gastrectomy, gastrointestinal suture and intestinal resection 7) Subjects who have some kind of food allergy 8) Subjects who have experienced sickness due to blood collection 9) Subjects who have difficulty drawing blood from the peripheral vein 10) Heavy drinker (over 40g alcohol/day) 11) Subjects who quit smoking for less than 6 months or smokers 12) Subjects who are shift workers and night workers 13) Subjects who regularly use, or have regularly taken within the past month, oral medications or supplements that may affect this study 14) Subjects judged as unsuitable for this study by the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-660hr of the plasma concentration change of the ingredient in the test food | — |
Secondary
| Measure | Time frame |
|---|---|
| AUC0-60hr, AUC0-156hr, AUC0-660hr of the plasma concentration of the ingredient in the test food AUC0-60hr, AUC0-156hr, AUC0-660hr of the plasma concentration change of the ingredient in the test food | — |
Countries
Japan
Contacts
Public ContactKanako Murase
TRANSGENIC INC. Clinical Research Dept.
Outcome results
None listed