None listed
Conditions
Interventions
Sponsors
Medical Corporation Hokubukai Utsukushigaoka Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Japanese males and females aged 20-64 years when consented. 2) Subjects whose levels are included between 100-125 mg/dL in fasting blood glucose or 120-199 mg/dL in fasting triglyceride at the time of screening. 3) Subjects who can be available on schedule days. 4) Subjects who agree to participate in this study and can put signature and date to informed consent form by themselves prior to the study.
Exclusion criteria
Exclusion criteria: 1) Subjects who have been diagnosed as metabolic syndrome 2)Subjects with a history of hepatic, renal, cardiac or organ disorders, diabetes or other serious diseases. 3) Subjects with a surgical history of digestive system (except appendicectomy). 4) Subjects currently under treatment with chronic diseases. 5) Subjects with food allergies to the food used in the study. 6) Subjects who wish to become pregnant during the study period or who are lactating or pregnant or may be pregnant. 7) Heavy drinkers (average amount of intake as pure alcohol is 60 g or more per day). 8)Subjects who take supplement emphasizing the inclusion of inulin, epigallocatechin, chlorogenic acid, epigallocatechin gallate, indigestible dextrin, 5-aminolevulinic acid, gallic acid, lactoferrin, mulberry leaf extract, salacia extract, kudzu flower extract, African mango tree extract, DHA / EPA, or rose hip extract or general health foods(e.g., protein diet) for 3 days or more per week and have continued to take it for 6 months or more T, and who cannot stop taking it during the study period . 9) Subjects taking the medicines (e.g., the Bislat Gold EX or the Naishitol Zaf), the Chinese medicine (e.g., the Bofutsushosan or the Daisaikoto) or the supplements claiming for the reduction of the body fat on diet. 10) Subjects who are participating in clinical trials or consumer monitoring other than this study or who are planning to participate during this study period. 11) Subjects who have donated 200 ml or more of blood after 1 month before the primary screening or plan to donate them before the end of the study. 12) Subjects who frequently skip breakfast. 13) Subjects who work during 22:00 to 6:00 (shift worker, night- shift worker, etc.). 14) Subject who need to avoid consuming food whose origin is not clearly indicated due to religious or other reasons. 15) Subjects judged as unsuitable for this study by the investigator with other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of between test food and placebo in changes of blood glucose, triglyceride and blood pressure from baseline in subjects within each range from normal high to mild | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison between test food and placebo in changes of blood glucose, triglyceride and blood pressure from each baseline in the entire subjects | — |
Countries
Japan
Contacts
Public ContactIsao Takehara
Clinical Support Corporation, Ltd. Food Service Division
Outcome results
None listed