No applicable
Conditions
Interventions
In consecutive 12 weeks, intake one test food (100g, a beverage containing 1*10^10 cfu of Bifidobacterium animalis subsp. lactis GCL2505, 2.0g of inulin and 9.0mg of paprika xanthophyll as an active i
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Males and females aged 20 to 59 years old. (2) Subjects their blood glucose level are in normal or border area (subjects their fasting blood glucose are less than 126 mg/dL or their blood glucose level of 120 min after OGTT are less than 200 mg/dL). (3) Subjects who show understanding of the study procedures and agreement with participating the study by written informed consent prior to the study.
Exclusion criteria
Exclusion criteria: 1) Subjects who didn't undergo abdominal surgical operation within 6 month before test start. 2) Subjects who are being treated medication at present. 3) Subjects who have allergy to test food. 4) Smokers 5) Subjects their living together has plane to participate to same clinical test. 6) Subjects who plan big change of lifestyle during test period. 7) Subjects with tendency of chronic diarrhea. 8) Subjects who have inappropriate medical history such as significant functional impairment in liver, kidney and/or heart-blood system. 9) Subjects who suspected chronic or serious infectious disease. 10) Females who are pregnant, lactating or possibility of pregnancy. 11) Subjects who have participated the other clinical test within 3 month before test start. 12) Subjects who can't refrain from consumption of lactic bacteria, bifidobacterium, oligosaccharide and/or dietary fiber rich foods during test period, of fermented foods such as the natto, pickles and/or cheese. 13) Subjects who regularly consume the supplement containing similar ingredient of Xanthophyll, a vegetable juice and/or a tomato juice more than 5 days a week. Subjects who can't refrain from consumption of the supplement and/or the juice mentioned above, of the wenzhou mandarin orange and/or that juice during test period. 14) Subjects who donated over 200mL blood and/or blood components within a month. 15) Males who donated over 400mL blood within the last 3 months. 16) Females who donated over 400mL blood within the last 4 months. 17) Males who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last 12 months are adding to the planned sampling amounts of this study. 18) Females who will be collected over 800mL blood and/or blood components when, the sampling amounts within the last 12 months are adding to the planned sampling amounts of this study. 19) Others they have been determined ineligible by principal investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insulin sensitivity (Matsuda-index) | — |
Secondary
| Measure | Time frame |
|---|---|
| * Insulin resistance (HOMA-IR) * Fasting blood glucose level * AUC of blood glucose * The number of Bifidobacterium in feces * Glycated albumin * BAP * d-RPMs * 8-OHdG * Accumulation level of advanced glycation end products | — |
Countries
Japan
Contacts
Public ContactMakoto Ichinohe
CPCC Company Limited Planning & Sales Department
Outcome results
None listed