An exploratory study of new features of test foods. - A placebo controlled, randomized, double blind, cross-over study
- Conditions
- Healthy adult
- Registration Number
- JPRN-UMIN000043066
- Lead Sponsor
- KSO Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 40
Not provided
(1)Subjects who has determined to be inappropriate as a subject by the investigator by a blood test performed on a screening test. (2)Subjects who have chronic disease and regularly use drugs and/or medicines and have serious complications. (3)Subjects who regularly use medicines related to intestinal regulation. (4)Subjects who has food allergy. (5)Subjects who take health foods (including Food for Specified Health Uses or Foods with Function Claims) and/or supplements on a daily basis. (6)Subjects who have digestive disorders that affect digestion and absorption and/or have a history of digestive surgery, and/or have disorders of the digestive tract such as stricture. (7)Subjects who couldn't take the prescribed meal to be carried out within the prescribed time in the screening test. (8)Subjects who had problems with gastrointestinal symptoms such as diarrhea and abdominal pain after taking the prescribed meal in the screening test. (9)Subjects who did not defecate pigmented stool within 26 hours after taking the prescribed meal and pigment capsule in the screening test. (10)Subjects who may do a lot of sweating work or exercise during the test period. (11)Subjects who smoke. (12)Subjects who usually have a tendency to develop diarrhea or constipation. (13)Subjects who has a medical history or current medical history of drug dependence and/or alcohol dependence. (14)Subjects who are participating in other studies that using foods, pharmaceuticals, and cosmetics now, or who have been participated or are willing to participate in other studies within a month from the date of informed consent. (15)Subjects who are judged as unsuitable for the study by the investigator for the other reasons.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fecal examination: Cholesterol, Crude fat, Sodium, Carbohydrates
- Secondary Outcome Measures
Name Time Method Fecal examination: Bile acid, Water content, Weight, Dietary fiber Urinalysis: Sodium, Creatinine