Effect of Test Food Intake on Blood Flow and Intestinal Environment.
- Conditions
- o
- Registration Number
- JPRN-UMIN000051004
- Lead Sponsor
- TES Holdings Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 24
Not provided
1) Individuals using medical products. 2) Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia. 3) Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease. 4) Individuals who are a patient or have a history of or endocrine disease. 5) Individuals with serious anemia. 6) Individuals who used a drug to treat a disease in the past 1 month. 7) Individuals whose BMI is less than 18.5kg/m2 and over 25kg/m2. 8) Individuals who have strong indefinite complaints due to menstruation and who may take medication to alleviate symptoms of anemia. 9) Individuals with constipation (less than 3 bowel movements per week, pain and bleeding during bowel movements, abdominal discomfort, etc.), and who may take medication to relieve constipation symptoms. 10) Individuals with inflammation and scratch at fingers. 11) Individuals who are a smoker. 12) Individuals who have excessive alcohol intake more than 20 g in a day of pure alcohol equivalent. 13) Individuals who have allergic reaction to ingredients of test foods and other foods or drugs. 14) Individuals with possible changes of life style during the test period. 15) Individuals who currently or within the past one month have a habit of continuously consuming citrus fruits (Unshu mikan, orange, lemon, navel, Iyokan, bitter orange, shikuwasa) and beverages or foods made from these fruits, or who plan to consume citrus fruits during the test period. 16) Individuals who have and had a habit to ingest food with functional claims, health foods, or supplements in the past 3 months or will ingest those foods during the test period. 17) Individuals who are or are possibly, or are lactating. 18) Individuals who participated in other clinical studies in the past 3 months. 19) Individuals judged inappropriate for the trial by the principal.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes, amount of change, AUC, and recovery rate of blood flow-related indexes in cold water stress test (blood flow measurement with laser doppler, skin surface temperature measurement with thermography). (Week0, Single dose, Week4 : before the cold stress test, just after the cold stress test, 2 min. after the cold stress test, 4 min. after the cold stress test, 6 min. after the cold stress test, 8 min. after the cold stress test, 10 min. after the cold stress test.)
- Secondary Outcome Measures
Name Time Method *Secondary indexes 1) Capillary evaluation by capillary scope(1) 2) Ubjective questionnaire(1) 3) Blood hesperetin(1) * Exploratory endpoint 1) Microbiome evaluation (genetic analysis [metagenomics]) (1) 2) Metabolite analysis (metabolomics) (1) *Safety indexes 1) Blood pressure, pulsation. (1) 2) Weight,body fat percentage,BMI(1) 3) Hematologic test. (2) 4) Blood biochemical test. (2) 5) Urine analysis. (2) 6) Doctor's questions(1) 7) Adverse events: number of cases and expression rate of adverse events(3) 8) Subject's diary(4) (1): Week0, Single dose, Week 4 (2): Week0, Week 4 (3): Single dose, Week 4 (4): From the first day of ingestion of a test material to the last day of the test