None(Healthy subjects)
Conditions
Interventions
A single ingestion of the natural extract - washout period(6 days or more)- single ingestion of the processed extract
A single ingestion of the processed extract - washout period(6 days or more)- sing
Sponsors
Medical Corporation Hokubukai Utsukushigaoka Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Japanese males and females from 20 to 64 years old when the consent is obtained 2) Subjects with the normal fasting serum triglyceride, HDL-cholesterol and LDL-cholesterol values at the screening test. 3) Subjects available at every designated visit. 4) Subjects who agree to participate in this study and can put a signature and date to informed consent form by themselves prior to the study.
Exclusion criteria
Exclusion criteria: (1) Subjects with hepatic, renal, cardiac or organ disorders or diabetes or other serious diseases. (2) Subjects with a surgical history of the digestive system (except appendicectomy). (3) Subjects with a history of a drug or food allergy. (4) Subjects currently under treatment with chronic diseases. (5) Subjects who are pregnant or intend to become pregnant during the study or are lactating. (6) Subjects who cannot restrict the intake of foods that may influence the measurement of the samples during the study. (7) Subjects who take excessive alcohol (equivalent to 60 g pure ethanol/day in average consumption). (8) Subjects who participate in other clinical trials. (9) Subjects who have a history of feeling ill or unwell during or after the blood draw. (10) Subjects who have donated over 400 mL of blood within the last three months prior to the screening of this study or expect to donate the same during the study. (11) Subjects with extremely irregular diet (night-shift worker, etc). (12) Subjects who have smoked within 6 months. (13) Subjects who need to avoid taking the foods that do not clearly indicate the origin of all ingredients, because of religions, etc. (14) Subjects judged as unsuitable for this study by the investigator for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of the serum lycopene concentration at each sampling point and of AUC 0-36h of lycopene between intake of processed tomato extract and normal tomato extract(The analysis of actual measured values and variation from baseline after the loading tomato extracts). | — |
Countries
Japan
Contacts
Public ContactYoshiyuki Shirakura
FUJIFILM Healthcare Laboratory Co., Ltd. Department of Supplement product management
Outcome results
None listed