Healthy adults
Conditions
Interventions
Preliminary test - the test before consumption of the test food - consumption of the usual amount of test food for 8 weeks and the test every week - the test after quit consumption of the test food.
Sponsors
Tokai Gakuen University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (1)Japanese healthy females aged 20 to 60 years old when consent acquisition. (2)Females who don't be given treatment by taking medicines, therapies and/or operations even seasonal, chronic or sudden case. (3)Females who show enough understanding of the clinical study procedures, and who agree with participating in the study by written informed consent from their own will. (4)Females those BMI are 18.5 to less than 30.0. (5)Females whose blood pressure (average from two times measurements) are within the conditions below. Systolic blood pressure is less or equal 139 mmHg. Diastolic blood pressure is less or equal 89 mmHg. (6)Females whose pulses are 40 to 100 times per minute. (7)Females whose body temperatures are 35.5 to 37.0 degrees Celsius. (8)Females who can prohibit excessive exercise during test period. (9)Females who basically take 3 meals a day and can prohibit drinking and eating too much. (10)Females who can contraception properly during test period. (11) Females who can understand and compliance to controlled matters.
Exclusion criteria
Exclusion criteria: (1) Females who have disorder that affect absorption, distribution, metabolism and/or excretion of test food, such as disease in digestive tract, liver, kidney, heart and/or circulation system. (2)Females who have surgery history in digestive tract such as gastrectomy, gastrointestinal suture surgery and/or intestinal resection etc., but except polypectomy and appendectomy. (3)Females who have medical history of cerebral vascular disorder. (4)Females who have specific constitution that occur allergy and/or hypersensitivity against test food. (5) Females who suspect to alcohol dependence and/or drug dependence. (6) Females who have attended other clinical trial and/or clinical study within 84 days before consent acquisition. (7) Females who have done 400mL of whole blood donation within 84 days before consent acquisition. Females who have done 200mL of whole blood donation within 28 days before consent acquisition. Females who have done 200mL of ingredient donation within 14 days before consent acquisition. (8)Females who are lactating and/or pregnant. (9) Females who engage in mid-night work.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Defecation frequency | — |
Secondary
| Measure | Time frame |
|---|---|
| Body Mass Index Condition of facial skin Microbiota of intestine Productive availability of equol | — |
Countries
Japan
Contacts
Public ContactAtsuhisa Nishimura
ICHIBIKI CO., LTD. Research Laboratory
Outcome results
None listed