Verification of the effects of test food on vascular endothelium functionality and gut environment
- Conditions
- Healthy men / female subjects
- Registration Number
- JPRN-UMIN000042014
- Lead Sponsor
- CPCC Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 36
Not provided
(1) Subjects who are currently receiving medication. (2) Subjects who have a plan or who have taken medication which would affects the trial result (drug for intestinal disorder, antihypertensive, laxative or antibiotics) within a month before the trial start. (3) Subjects who are regularly consuming food for specified health uses (FOSHU), food with function claims, supplement and/or health foods which would affects the trial results for more the 3 times per week. (4) Subjects who are breast-feeding, pregnant, and are planning pregnancy. (5) Subjects who have current medical history/anamnesis of severe cardiac, hepatic, renal or digestive diseases. (6) Subjects who are heavy use of alcohol. (7) Subjects who have history of smoking. If subject have quit smoking for more than a month prior to trial, the subject could be included. (8) Subjects with irregular life style and diet. (9) Subjects who have allergies to food or medication. (10) Subjects who are currently participating, or who have been participated to other study for medicine or food within the last 4 weeks of the trial, or who possibly participate to other clinical trial after agreement of this study. (11) Subjects who donated over 200mL blood and/or blood components within a month to the current study. (12) Males who donated over 400mL blood and/or blood components within the last 3 months to the current study. (13) Females who donated over 400mL blood and/or blood components within the last 4 months to the current study. (14) 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. (15) 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. (16) 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 Flow Mediated Dilation (FMD)
- Secondary Outcome Measures
Name Time Method - Blood pressure (Systolic/Diastolic) - Reactive hyperemia peripheral arterial tonometry (RH-PAT) - Gut microbiota - Gut metabolites - Defecation characteristics (defecation frequency, No, of defecation, quantity, shape, color, incomplete evacuation, abdominal pain, fecal odor) - QOL Questionnaire - Laboratory test value