Healthy adults
Conditions
Interventions
Intake test food, 1 tablets a day, for eight continuous weeks.
Intake control food, 1 tablets a day, for eight continuous weeks.
Sponsors
Aichi Shukutoku University.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Healthy Japanese aged 18 to 65 years old when consent acquisition. (2)Japanese who don't be given treatment by taking medicines, therapies and/or operations even seasonal, chronic or sudden case. (3)Japanese 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)Japanese 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. (5)Japanese whose pulses are 40 to 100 times per minute. (6)Japanese whose body temperatures are 35.5 to 37.0 degrees Celsius. (7)Japanese who basically take 3 meals a day and can prohibit drinking and eating too much(Includes overdose of alcohol, stimulants and caffeine). (8)Japanese who can contraception properly during test period. (9)Japanese who can understand and compliance to controlled matters. (10) Japanese who can prohibit the intake of supplements and foods with functional claims.
Exclusion criteria
Exclusion criteria: (1) Japanese 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)Japanese who have surgery history in digestive tract such as gastrectomy, gastrointestinal suture surgery and/or intestinal resection etc., but except polypectomy and appendectomy. (3)Japanese who have medical history of cerebral vascular disorder. (4)Japanese who have specific constitution that occur allergy and/or hypersensitivity against test food. (5) Japanese who suspect to alcohol dependence and/or drug dependence. (6) Japanese who have attended other clinical trial and/or clinical study within 84 days before consent acquisition. (7) Japanese who have done 400mL of whole blood donation within 84 days before consent acquisition. Japanese who have done 200mL of whole blood donation within 28 days before consent acquisition. Japanese who have done 200mL of ingredient donation within 14 days before consent acquisition. (8)Japanese who are lactating and/or pregnant. (9) Japanese who engage in mid-night work. (10) Japanese who are on any medication (please report if medication is required during this clinical study). (11) Japanese who taking contraceptive pills for any purpose.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (1)Defecation score (property, frequency) [after 8 weeks of ingestion] | — |
Secondary
| Measure | Time frame |
|---|---|
| (1)Defecation score (property, frequency) [after 4 weeks of ingestion] (2)Defecation status (experience, pain, score.) [after 4 and 8 weeks of ingestion] (3)Sleep status, physical condition (stress, fatigue, skin quality, anemia, hay fever, menstruation) [after 4 and 8 weeks of ingestion] | — |
Countries
Japan
Contacts
Public ContactNoriyuki Asai
ICHIBIKI CO., LTD. Research Laboratory
Outcome results
None listed