Effect of a Functional Food for Postprandial Triglyceride.
- Conditions
- /A (healthy adults)
- Registration Number
- JPRN-UMIN000042359
- Lead Sponsor
- TES Holdings Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 17
Not provided
[1]Individuals using medical products. [2]Individuals who are or are under treatment or have a history of hyperlipidemia, hypertension, diabetes, mental disabilities, sleep disorder or the other serious dysfunctions. [3]Individuals who used a drug to treat in the past 1 month (One-shot medicine of a headache, menstrual pain and a cold removes it). [4]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, lung disease, or blood disease. [5]Individuals who have digestive organ disease (disease of an appendix is removed). [6]Individuals whose menstrual period is during the test period and with serious anemia or poor physical condition during the period (only for females). [7]Individuals whose BMI is over 30kg/m2. [8]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. [9]Individuals with serious anemia. [10]Individuals who are difficult to conduct blood collections over time. [11]Individuals who are sensitive to test products or causes severe allergy in a food and medical supplies. [12]Individuals who cannot intake every diet the day before the inspection day or every loading food. [13]Individuals who are based on average alcohol per 1 day and exceeds 60g/day. [14]Individuals whose life style will change during the test period (ex. travel for a long time). [15]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements which adopt to improve lipid metabolism or glucose metabolism in the past 3 months or will ingest those foods during the test period. [16]Individuals who are or are possibly pregnant, or are lactating. [17]Individuals who participated in other clinical studies in the past 3 months. [18]Individuals judged inappropriate for the study by the principal.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method [1]Efficacy evaluation (changes, increase and decrease, Cmax, delta Cmaxm AUC and iAUC of TG and NEFA(1); blood viscosity and lipid composition analysis(2)). (1): Screening; Week 0, Week 4 (before ingestion of a challenge diet, and 2, 3, 4, 6 hours after ingestion of a challenge diet). (2): Screening; Week 0, Week 4 (before ingestion of a challenge diet, and 6 hours after ingestion of a challenge diet).
- Secondary Outcome Measures
Name Time Method *Safety [1]Blood pressure, pulsation(1). [2]Weight, body fat percentage, BMI(2). [3]Doctor's questions(1). [4]Subject's diary(3). *Other indexes [1]Hematologic test(4). [2]Blood biochemical test(2). [3]Urine analysis(4). [4]Anti-Aging QOL Common Questionnaire(2). (1):Screening; Week 0, Week 4 (before ingestion of a challenge diet, and 6 hours after ingestion of a challenge diet). (2):Screening; Week 0, Week 4 (before ingestion of a challenge diet). (3):From two days before ingestion of a challenge diet in observation period I to one day before ingestion of a challengediet in Week 4. (4):Screening. (5): Week 0, Week 4 (before ingestion of a challenge diet).